Manual versus target-controlled infusion of balanced propofol during diagnostic colonoscopy A prospective randomized controlled trial

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1 514 Srp Arh Celok Lek Sep-Oct;144(9-10): DOI: /SARH V ОРИГИНАЛНИ РАД / ORIGINAL ARTICLE UDC: ; Mnul versus trget-controlled infusion of blnced propofol during dignostic A prospective rndomized controlled tril Ver Vučićević 1, Brnko Milković 1,2, Milord Tešić 3, Jelen Djordjević 4, Srdjn Djurnović 2,5 1 Clinicl Center of Serbi, Center for Anesthesiology nd Renimtology, Belgrde, Serbi; 2 University of Belgrde, School of Medicine, Belgrde, Serbi; 3 Clinicl Center of Serbi, Clinic for Crdiology, Belgrde, Serbi; 4 Higher Eduction School of Professionl Helth Studies in Belgrde, Belgrde, Serbi; 5 Clinicl Center of Serbi, Clinic for Gstroenterology nd Heptology Belgrde, Serbi SUMMARY Introduction There is n incresing interest in blnced propofol sedtion (BPS) for in outptient settings. Propofol is potent nesthetic gent for this purpose nd hs nrrow therpeutic rnge, which increses risk of crdiovsculr nd respirtory complictions in cse of improper dministrtion. Objective The im of this study ws to compre ptients sfety nd comfort of endoscopists in two methods of BPS trgeting deep sedtion propofol trget-controlled infusion (TCI) nd mnul intrvenous titrtion technique (MT) during. Methods This prospective rndomized controlled tril included 90 ptients (clss I or II of the Americn Society of Anesthesiologists) deeply sedted with propofol, codministered with smll doses of midzolm nd fentnyl. Propofol ws given by MT technique (45 ptients) or by TCI (45 ptients). The following dverse effects were recorded: hypotension, hypertension, brdycrdi, tchycrdi, hypoxemi, brdypne, pne, hiccupping, nd coughing, s well s endoscopist s comfort during by mens of questionnire. Results The MT group compred to the TCI group hd lower men rteril pressure in the 10th minute fter the beginning (p = 0.017), nd t the end of (p = 0.006), higher oxygen sturtion in the fifth minute (p = 0.033), nd in the 15th minute (p = 0.008) fter the beginning of, nd lower hert rte t the beginning of the procedure (p = 0.001). There were no sttisticlly significnt differences in dverse events. Endoscopist s comfort during ws high 95.6% in the TCI group vs. 88.9% in the MT group (p = 0.069). Conclusion MT is cliniclly s stble s TCI of propofol for deep sedtion during, nd endoscopists experienced the sme comfort during in both groups. Thus, both combintions re suitble for deep sedtion during dignostic. Keywords: blnced propofol sedtion; deep sedtion; ; endoscopist s comfort; trgetcontrolled infusion Correspondence to: Ver VUČIĆEVIĆ Center for Anesthesiology nd Renimtology Clinicl Center of Serbi Višegrdsk Belgrde Serbi vervucicevic.bg@gmil.com INTRODUCTION Colonoscopy is n importnt invsive procedure, but n uncomfortble, pinful, nd unplesnt experience for lot of ptients [1]. For in outptient settings, deep sedtion in spontneously brething ptients is incresing in populrity, despite reltively high incidence of crdiovsculr nd respirtory suppression [2]. Propofol is incresingly used for sedtion during due to its phrmcologicl properties rpid onset of ction nd short recovery profile, moderte ntiemetic, nlgesic, nd mnestic effect [3, 4, 5]. However, propofol induces respirtory nd crdic depression which is dose-dependent nd my put ptients t risk. Therefore, there is n incresing interest in blnced propofol sedtion (BPS) with ddition of benzodizepines nd/or opioids in smll doses, the dose of propofol my be reduced [6, 7]. Propofol hs nrrow therpeutic rnge nd the current stndrd dministrtion technique in is intermittent dministrtion of propofol bolus [8], ccording to desired sedtion depth [4]. Among vrious methods which re now vilble for dministrtion of propofol, trget-controlled infusion (TCI) is one of the most sophisticted ones [9]. The bsic principle of TCI is tht nesthesiologist sets nd then djusts trget concentrtions of propofol. The infusion rte is djusted utomticlly ccording to vlidted phrmcokinetic model (Mrsh s or Schnider s) [10, 11], nd TCI mintins present concentrtion of propofol in the plsm (Cp) or the brin (Ce). OBJECTIVE The im of this clinicl study ws to compre ptients sfety nd endoscopists comfort in two methods of BPS trgeting deep sedtion propofol TCI with mnul intrvenous (i.v.) titrtion technique (MT) during.

2 Srp Arh Celok Lek Sep-Oct;144(9-10): METHODS We conducted prospective rndomized controlled clinicl tril which included 90 ptients, compring ptients sfety nd endoscopists comfort of the two different dministrtion techniques of propofol to ptients receiving concomitntly smll doses of midzolm nd fentnyl. The ptients were one-to-one rndomized into two groups MT nd TCI group using rndom-numbers tble. The study took plce t the Endoscopy Deprtment of the Clinic for Gstroenterology nd Heptology, Clinicl Centre of Serbi, Belgrde, during period of six months (from April through October, 2013). Seven expert endoscopists with similr clinicl experience performed colonoscopies in the tril. Propofol dministrtion nd dose djustments were crried out by one nesthesiologist, with the help of trined nurses. The study ws pproved by Institutionl Ethics Committee of the Clinicl Centre of Serbi (No. 4183/ ) nd written informed consent ws obtined from ll the ptients. We included 90 ptients, who signed the informed consent, of both sexes, yers old (body weight from 50 kg to 120 kg), clssified into group I or II ccording to the Americn Society of Anesthesiologist (ASA), recruited from the prctices nd scheduled for dignostic outptient with deep sedtion. Indictions for were s follows: screening for colorectl cncer, dirrhe, constiption, nd bleeding. The following ptients were excluded from the study: those llergic to the study drugs, ptients with previous problems with nesthesi or sedtion, ptients with history of stridor, snoring or sleep pne, ptients with neck bnormlities, nd those clssified into groups III or IV of Mllmpti clssifiction [12], ptient with neuropsychitric, crdic, respirtory, renl disorders, those in pregnnt stte, nd with history of lrge-bowel surgery. If, for ny reson, the endoscopist could not complete the procedure, the ptient ws excluded from the finl nlysis. All the ptients underwent n overnight fst nd bowel clensing by drinking 4 l of polyethylene glycol electrolyte solution (Fortrns, Beufour Ipsen Industrie, Dreux, Frnce). In the endoscopy room, intrvenous ccess ws obtined nd ech ptient received 8 ml/kg/h of isotonic sline solution in the form of infusion. Oxygen ws supplemented with msk (6 l/min.). Pre-induction mediction for ll the ptients ws s follows: midzolm (Dormicum, Roche Phrm, Reinch, Switzerlnd, 5 mg/5 ml) in bolus of 2 mg for the ptients up to 70 kg, nd 3 mg for those over 70 kg, nd fentnyl (Fentnyl, Jnssen-Cilg, Br, Switzerlnd, 0.05 mg/ml) in bolus of 1 ml for the ptients between 50 kg nd 60 kg, 1.5 ml for the ptients between 60 kg nd 80 kg, nd 2 ml for those over 80 kg. Both drugs were dministrted slowly (>60 seconds), two minutes before propofol. The ptients in the MT group received propofol intrvenously (Diprivn, Astr-Zenec, Stocholm, Sweden, 10 mg/ml), in bolus of 0.5 mg/kg, nd then mg were titrted every one to two minutes. The TCI group received propofol with TCI pump (Alris PK, Crdinl Helth, Dublin, OH, USA), ccording to the Schnider s phrmcokinetic model, with the initil Ce of 2.5 µg/ml. This concentrtion ws incresed or decresed by µg/ml until the deep level of sedtion ws chieved. After the deep sedtion level hd been chieved, ws performed. The Modified Observer s Assessment of Alertness/Sedtion (MOAA/S) scle ws used to document the ptients responsiveness scores [13]. The ptients who lost response to verbl commnds nd eyelsh reflex (MOAA/S = 2) were considered to be in deep sedtion. Administrtion of propofol ws stopped t the end of the by reching the bse of cecum nd seeing the lndmrk of ileocecl vlve. The ptients were monitored t five-minute intervls; hert rte, systolic nd distolic rteril pressure, then men rteril blood pressure were mesured utomticlly using ptient monitor (Mec-1000, Mindry Medicl Interntionl Limited, Shenzhen, Chin), s well s blood oxygen sturtion (SpO 2 ) using pulse oximeter (Oxipc, Dreger, Lübeck, Germny); respirtion rte per minute ws recorded by visul inspection nd plption. Endoscopist used Olympus (Olympus Corportion, Tokyo, Jpn) nd Pentx (Pentx Corportion, Tokyo, Jpn) video-endoscopes. The following observed dverse events in both groups (MT nd TCI) were recorded nd compred [14]: hypotension [men rteril pressure (MAP) < 60 mmhg], hypertension (MAP > 105 mmhg), brdycrdi [hert rte (HR) < 45 bets/min.], tchycrdi (HR > 115 bets/min.), hypoxemi (blood oxygen desturtion, SpO 2 < 92% for longer thn 30 seconds), brdypne (number of respirtions < 6/minute), pne (cesstion of brething) nd other dverse events relted to sedtion (coughing, hiccupping) [15]. Ech use of the following mneuvers ws lso registered: lifting the chin, increse in oxygen flow, plcement of n orophryngel irwy, ssisted ventiltion with bg-msk, nd endotrchel intubtion. After colonoscopies we sked the endoscopists to ssess the degree of difficulty of with n 11-point (0 10) rting scle, with 0 being very esy nd 10 extremely difficult. The endoscopists lso ssessed the ptients sedtion using verbl scle for the qulity of sedtion (excellent, good, fir, poor) [16], nd ptients comfort bsed on the observtion of defensive rections during [17]. The movement ws rted s none (no movement), mild (fce grimcing or smll movement), moderte (movement without the need to discontinue the procedure) or severe (movement requiring discontinution of the procedure). We lso sked the endoscopists to ssess the overll stisfction with procedure using five-point verbl scle for comfort (excellent, very good, good, fir, poor) [18]. Sttisticl nlysis The clcultion of smple size ws mde for two independent smples, with equl number of ptients in ech group (1:1). Probbility of type 1 sttisticl error (lph) ws set to 0.05, nd power of the study to 80%. The effect size ws clculted from the observed difference in time to opening of the eyes fter trget-controlled versus mnully-

3 516 Vučićević V. et l. Mnul vs. trget-controlled infusion of blnced propofol during dignostic controlled infusion of propofol in the study of Pssot et l. [19] (4.6 ± 2.0 minutes vs. 6.8 ± 2.5 minutes). The smple size ws clculted by G*Power softwre version (Heinrich Heine University Düsseldorf, Düsseldorf, Germny) [20], nd it turned out to be 45 ptients per group. Numeric vribles were described by centrl tendency mesures (the men) nd by mesures of sttisticl dispersion (the stndrd devition). Ctegoricl vribles were described by percentges. The Student s t-test ws used for comprison of the study groups fter confirming norml distribution of dt within the groups. Person s χ 2 test ws used for testing differences in ctegoricl vribles mong the study groups. The differences were considered significnt if probbility of null hypothesis ws less thn All clcultions were performed by IBM SPSS Sttistics for Windows, version 20.0 (IBM Corp., Armonk, NY, USA). RESULTS Ninety ptients in totl were enrolled in the study, nd 45 of them were llocted to ech of the two groups. Bseline chrcteristics of the ptients were similr in both groups, nd re shown in Tble 1. The durtion of in the MT group ws ± 5.16 minutes, nd in the TCI group 9.66 ± 5.18 minutes (p = 0.543). Totl dose of propofol in the MT nd TCI groups were ± mg nd ± mg, respectively (p = 0.563). Chnges in MAP, HR, respirtion rte, oxygen sturtion nd levels of sedtion during re presented in Tble 2. The MAP vlues before sedtion nd during were similr in both groups. However, in the 10th minute during, the MAP in the MT group ws significntly lower in comprison to the TCI group (86.50 ± 9.04 vs ± 6.37 mmhg, p = 0.017), nd the sme ws observed t the end of the (86.55 ± 9.28 vs ± 7.05 mmhg, p = 0.006). HR t the beginning of ws significntly higher in the MT group in comprison to the TCI group (79.55 ± vs ± bets/minute, p = 0.001), but during the procedure the difference in HR between the groups disppered. In both groups oxygen sturtion during the procedure ws in the rnge from 97% in the MT to 100% in the TCI group. The sturtion ws significntly lower in the MT group, compred with the TCI group, in the fifth (98.84 ± 1.67 vs ± 0.82%, p = 0.033) nd the 15th minute (97.38 ± 2.26 vs ± 0.51%, p = 0.008) of the procedure. In regrd to the respirtion rte, it ws lower in the TCI group in the fifth minute (12.26 ± 2.75 vs ± 4.0 min -1, p = 0.000) nd t the end of the procedure (13.28 ± 2.17 vs ± 3.0 min -1, p = 0.001). Tble 1. Demogrphic chrcteristic of the ptients Demogrphic chrcteristics MT group TCI group Sex (mle/femle), n 15/30 19/ b Age (yers), men ± SD ± ± Weight (kg), men ± SD ± ± Height (cm), men ± SD ± ± BMI (kg/m 2 ), men ± SD ± ± 3, Alcohol consumption (yes/no), n 0/45 3/ b Smoking (yes/no), n 18/27 21/ b ASA (I/II), n 29/16 25/ b MT mnul technique; TCI trget-controlled infusion; BMI body mss index; ASA Americn Society of Anesthesiologists; n number in group; SD stndrd devition; Student s t-test; b χ 2 test; sttisticl significnce p < 0.05 p Tble 2. Monitored prmeters before nd during Mesuring points MAP (mmhg) HR (bets/ min.) Oxygen sturtion (%) Respirtion rte per minute MOAA/S score Immeditely before sedtion (bsic vlue) Strt of fter 5 min. fter 10 min. fter 15 min. fter 20 min. The end of MT group ± ± ± ± ± ± ± 9.28 TCI group ± ± ± ± ± ± ± 7.05 p MT group ± ± ± ± ± ± ± TCI group ± ± ± ± ± ± ± p MT group ± ± ± ± ± ± ± 1.83 TCI group ± ± ± ± ± ± ± 0.77 p MT group ± ± ± ± ± ± ± 3.03 TCI group ± ± ± ± ± ± ± 2.17 p MT group 5* 2.24 ± ± ± ± ± 0.00 / TCI group 5* 2.00 ± ± ± ± ± 0.00 / p / / / / MT mnul technique; TCI trget-controlled infusion; MAP men rteril pressure; HR hert rte; SD stndrd devition; MOAA/S Modified Observer s Assessment of Alertness/Sedtion, scle being s follows: 6 = gitted; 5 = responds to nme in norml tone; 4 = lethrgic response to nme in norml tone; 3 = responds to nme clled loudly; 2 = responds to mild prodding/shking; 1 = does not respond to mild prodding/shking; nd 0 = does not respond to deepstimulus sternl rub * immeditely before sedtion (bse vlue) = 5; mesured vlues refer to the mesured points from the strt until the end of the Student s t-test; Vlues re men ± SD; sttisticl significnce p < doi: /SARH V

4 Srp Arh Celok Lek Sep-Oct;144(9-10): Tble 3. Endoscopist s comfort nd judgment of ptient s comfort Questions MT group TCI group How would you rte difficulty of (men ± SD), rting scle (0 10) 5.20 ± ± Excellent 41 (91.1) 43 (95.6) Wht ws ptient s sedtion for like, n (%) Good 3 (6.7) 2 (4.4) Fir 1 (2.2) / 0.536b Poor / / No movements 40 (88.9) 43 (95.6) Wht ws ptient s comfort during like, n (%) Mild movements 2 (4.4) 2 (4.4) Moderte movements 1 (2.2) / 0.375b Severe movements 2 (4.4) / Excellent 40 (88.9) 43 (95.6) Very good / 2 (4.4) Wht ws your comfort during like, n (%) Good 3 (6.7) / 0.069b Fir 2 (4.4) / Poor / / MT mnul technique; TCI trget-controlled infusion; SD stndrd devition; Student s t-test; b χ 2 test; sttisticl significnce p < 0.05 p Tble 4. Procedure-relted time nd sedtive doses Procedure/sedtion times MT group (men ± SD) TCI group (men ± SD) Induction time (min.) 3.31 ± ± Time of deeper sedtion (min.) ± ± Totl sedtion time (min.) ± ± Erly eye-opening time, (min.) 5.91 ± ± Durtion of (min.) ± ± Propofol (mg) ± ± Midzolm (mg) 2.60 ± ± Fentnyl (ml) 1.59 ± ± MT mnul technique; TCI trget-controlled infusion; SD stndrd devition; Student s t-test; sttisticl significnce p < 0.05 Vlues of MAP, HR, SpO 2 nd respirtion rte per minute in both groups were significntly bove the minimum cceptble vlues of 60 mmhg, 45 bets/minute 92% nd six breths per minute, respectively. Gret mjority of the ptients from both groups reched the desired level of sedtion (MOAA/S score = 2), from the strt until the end of, but the ptients in the TCI group in the fifth minute during the hd deeper sedtion level thn the ptients in the MT group (2.00 ± 0.00 vs ± 0.43, p = 0.001). Deep sedtion level ws chieved in both groups without risk of oxygen desturtion. None of the ptients required increse in oxygen flow, plcement of n orophryngel irwy, the ssisted ventiltion with bg-msk, or endotrchel intubtion. However, the chin hd to be lifted in one ptient from the MT group. Occurrence rte of dverse events relted to sedtion were similr in both groups, with only one hiccupping in the TCI group nd two in the MT group (p = 0.554) nd without coughing in both groups. Endoscopists comfort during nd their judgment of ptients comfort is shown in Tble 3. All endoscopists completed the questionnire. There were no p sttisticl differences between the groups. Difficulty rte of ws 5.2 ± 1.7 in the MT group vs. 5.5 ± 2.37 in the TCI group (p = 0.422). Endoscopists registered five ptients (11%) with movements in the MT group, wheres in TCI there were two ptients with movements (p = 0.375). The overll stisfction with ptients sedtion ws high, 91.1% described it s excellent in the MT group vs. 95.6% who described it s excellent in the TCI group (p = 0.536). Also, endoscopists ssessment of their own comfort ws high, 95.6% in the TCI group vs. 88.9% in the MT group (p = 0.069). Men vlues of propofol, midzolm, fentnyl doses, dministered to the study groups, nd the prmeters of sedtion nd procedurl time re shown in Tble 4. The observed differences were not significnt. In the TCI group, Ce min = 1 µg/ml, Ce mx = 4.5 µg/ml, nd mod = 2.3 (TCI rnge of propofol: 1 µg/ml 4.5 µg/ml, mod = 2.3) DISCUSSION As fr s we know, this is the first rndomized, prospective study which compred dministrtion of propofol by titrtion with TCI following intrvenous dministrtion of midzolm nd fentnyl for chieving deep sedtion in dignostic. However, despite numerous publictions describing propofol use in, there re limited dt studying the incidence of crdiorespirtory complictions of BPS trgeted to deep sedtion. Our study shows tht lthough severl crdiopulmonry prmeters were more stble numericlly in the TCI group, the MT group lso mintined the vlues sufficiently bove the lower limit indicted. No ptients in both groups required dditionl oxygen, orophryngel irwy, endotrchel intubtion, or ssisted ventiltion. Seven endoscopists prticipted in the study, nd their comfort ws the sme in both groups. Our results of endoscopists comfort re similr to those of Ching et l. [21]: they compred the propofol dministrtion by TCI using Schnider s model with mnully

5 518 Vučićević V. et l. Mnul vs. trget-controlled infusion of blnced propofol during dignostic controlled propofol infusion, with both groups premedicted with lfentnil, for the sme-dy bidirectionl endoscopy in deep sedtion. They reported high endoscopists stisfction score in both groups, but nurse nesthetists hd to dditionlly ssist the upper irwys throughout the procedure for the group of ptients with mnully controlled propofol infusion. This result is in correltion with ours: the chin hd to be lifted in one ptient, nd four ptients movements were registered in the MT group. Unlike our reserch, in this study the TCI with propofol gve less hemodynmic nd respirtory dverse events thn mnully controlled propofol infusion. The question whether sedtion technique influences endoscopist s comfort ws investigted by Mznikov et l. [22] Anesthesiologist-mnged propofol sedtion with constnt propofol infusion in deep sedtion hd no impct on the degree of gstroenterologist s stisfction when compred with ptient-controlled moderte sedtion with propofol/remifentnil in endoscopic retrogrde cholngiopncretogrphy [22]. Also, the study of Stonel et l. [23] showed tht endoscopists hd similr stisfction during, compred with ptient-controlled sedtion using TCI of propofol with nesthesiologist-dministered propofol bolus technique trgeting moderte sedtion. Advntge of TCI over mnul regimen ws shown in the study of Chn et l. [17], in which they compred TCI with propofol using Mrsh s phrmcokinetic model with intermittent bolus of sedtive cocktil (midzolm + lfentnil + smll doses of propofol) during deep sedtion for ; the TCI group produced less hypoxi, hypotension nd brdycrdi thn with intermittent bolus of sedtive cocktil. The dvntges of the TCI were lso shown in the study of Abslom et l. [24] with closed-loop control of moderte sedtion for by using bispectrl index. None of the ptients becme pneic, required irwy support or becme hemodinmiclly unstble while sedted. On the other hnd, Eberl et l. [25] reported less hemodynmic stbility with combintion of lfentnil nd TCI of propofol thn when lfentnil lone or combintion of midzolm nd fentnyl were used for chieving moderte sedtion during. The propofol group experienced more hypotensive events, but less oxygen desturtion episodes, similr s with the opioid-only group. Both propofol lone nd propofol in combintion with opites nd/or benzodizepines re frequently used during to chieve moderte levels of sedtion [3]. Lee et l. [7] found no significnt differences between the blnced propofol sedtion nd conventionl groups (midzolm nd meperidine) with regrd to the rtes of crdiopulmonry complictions, but BPS provided significntly higher level of endoscopist s stisfction. Incresing interest in BPS titrted to deep sedtion is shown in the study of Ho et l. [26]: compring lfentnil nd fentnyl in BPS during gstroscopy nd they reported the sme sfety profile. In our hospitl, ptients nd endoscopists fvor highqulity sedtive nd pin-free. Therefore, the ASA level of deep sedtion (MOAA/S = 2) ws set in our reserch [13, 27]. In study of 17,999 endoscopic procedures performed over 8 yers, the uthors concluded tht deep sedtion during endoscopic procedures is sfe nd dverse events occurred in smll proportion of ptients (4.5%) [28]. In the present study, deep sedtion level ws chieved in both groups without crdiorespirtory risk. Also, deep sedtion showed excellent endoscopists comfort nd low incidence of dverse events such s hiccup nd cough [29, 30]. El Chfic et l. [15] reported tht the rte of coughing ws very low in 757 ptients deeply sedted for endoscopy only 13% hd t lest one cough nd 3% prolonged cough. Although the ptients from both groups were without coughing in our study, hiccupping ws more frequent in the MT group (6.7% vs. 3.3%) which did not ffect excellent comfort of the endoscopists. The limittions of our study include the ptients selection bis s they were ll of ASA I nd II sttus nd below 65 yers of ge. It should be noted tht exmintions in Serbi re not routinely done in sedtion. They re indicted by gstroenterologist for the ptients who re frid of exmintion, or hve low pin tolernce, or previous unsuccessful exmintions. It is lso possible tht we missed episodes of hypotension lrger thn the recorded ones, but the shorter intervls of pressure mesuring during the procedure, which pproximtely lsted 15 to 20 minutes, s well s invsive precise blood pressure monitoring, were inconvenient for the ptients. In this study, seven specilists were performing ll colonoscopies. Idelly, future studies should be done with single specilist to insure consistency of the procedure. CONCLUSION Both techniques of dministrtion of blnced propofol, MT nd TCI, provide the sme sfety nd endoscopist s comfort in deep sedtion, thus both combintions re suitble during dignostic. TCI might hve some dvntges, since severl crdiopulmonry indictors were more stble numericlly. For strtegy to be introduced to dily prctices, method hs to be not only cliniclly effective but lso cost-effective. From tht point of view further observtion is wrrnted regrding cost-effectiveness of TCI in comprison to MT. ACKNOWLEDGEMENT Tril registrtion: the study ws pproved by Institutionl Ethics Committee of the Clinicl Centre of Serbi (No. 4183/ ) nd in ISRCTN registry with study ID ISRCTN doi: /SARH V

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7 520 Vučićević V. et l. Mnul vs. trget-controlled infusion of blnced propofol during dignostic Поређење болусне и циљаном концентрацијом вођене примене пропофола током дијагностичке колоноскопије проспективна рандомизована контролисана студија Вера Вучићевић 1, Бранко Милаковић 1,2, Милорад Тешић 3, Јелена Ђорђевић 4, Срђан Ђурановић 2,5 1 Клинички центар Србије, Центар за анестезиологију и реаниматологију, Београд, Србија; 2 Универзитет у Београду, Медицински факултет, Београд, Србија; 3 Клинички центар Србије, Клиника за кардиологију, Београд, Србија; 4 Висока здравствена школа струковних студија у Београду, Београд, Србија; 5 Клинички центар Србије, Клиника за гастроентерохепатологију, Београд, Србија КРАТАК САДРЖАЈ Увод Све је веће интересовање за примену балансиране седације пропофолом (BPS) током колоноскопије у амбулантним условима. Пропофол је потентан анестетик са малом терапијском ширином, а неправилним интравенским давањем повећава се ризик од кардиоваскуларних и респираторних компликација. Циљ рада Циљ ове студије је био да се пореди безбедност пацијента и комфор ендоскописте применом две методе BPS у дубокој седацији: циљано контролисаном инфузијом (TCI) и давањем пропофола у болусима у одређеним временским интервалима (MT) током колоноскопије. Методе рада Ово је проспективна рандомизована контролисана студија са 90 пацијената који су испунили услове за укључивање у студију (класификације I или II Америчког удружења анестезиолога), дубоко седираних пропофолом уз претходно интравенско давање малих доза мидазолама и фентанила. Пропофол је даван MT (45 пацијената) или TCI (45 пацијената) техником. Бележена су следећа нежељена дејства: хипотензија, хипертензија, брадикардија, тахикардија, хипоксемија, брадипнеа, апнеа, штуцање и кашаљ, а кроз упитник је испитан комфор ендоскописте током колоноскопије. Резултати MT група је у поређењу са TCI имала нижи средњи артеријски притисак у десетом минуту после почетка (p = 0,017) и на крају колоноскопије (p = 0,006), виши степен сатурације у петом минуту (p = 0,033) и у петнаестом минуту (p = 0,008) после почетка колоноскопије, као и спорији пулс на почетку процедуре (p = 0,001). Није било статистички значајне разлике у испољавању нежељених догађаја током примене пропофола на ова два начина. Комфор ендоскописта током колоноскопије је био висок, 95,6% у TCI према 88,9% у MT групи (p = 0,069). Закључак MT је клинички безбедна као и TCI пропофола, а комфор ендоскописта током колоноскопије је исти у обе групе, тако да су обе технике адекватне за дубоку седацију током дијагностичке колоноскопије. Кључне речи: балансирана седација пропофолом; дубока седација; колоноскопија; комфор ендоскописте Примљен Received: 12/11/2015 Ревизија Revision: 29/03/2016 Прихваћен Accepted: 01/04/2016 doi: /SARH V