Clinical Trial Details (PDF Generation Date :- Sun, 10 Mar 2019 06:52:14 GMT) CTRI Number Last Modified On 29/07/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2016/08/007125 [Registered on: 01/08/2016] - Trial Registered Retrospectively No Interventional Drug Randomized, Crossover Trial To compare the responses of pulse rate and blood pressure for electroconvulsive therapy in general anesthesia when dexmedetomidine, lignocaine and esmolol are used. A comparison of two doses of Dexmedetomidine, Esmolol and Lignocaine for the prevention of haemodynamic response to electroconvulsive therapy under general anaesthesia Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NIL NIL Details of Principal Investigator Sanchita Garg Phone 09356823568 Assistant Professor-Anesthesiology doc.sanchita@gmail.com Details Contact Person (Scientific Query) Devangi Parikh Phone 9820471638 ASSOCIATE PROFESSOR-ANAESTHESIOLOGY sdevangi10@gmail.com Details Contact Person (Public Query) Devangi Parikh ASSOCIATE PROFESSOR-ANAESTHESIOLOGY page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Phone 9820471638 sdevangi10@gmail.com Source of Monetary or Material Support > Lokmanya tilak municipal medical college and lokmanya tilak municipal general hospital Type of Sponsor Dr Devangi Parikh List of Countries of Principal Investigator Dr Sanchita Garg Primary Sponsor Details Lokmanya Tilak Municipal General Hospital Lokmanya Tilak Municipal medical college and hospital Sulochana Shetty road Sion, - Government medical college Lokmanya Tilak Municipal medical college and hospital Sulochana Shetty road Sion, - of Site Site Phone// Lokmanya Tilak Municipal General Hospital Psychiatry OPD. Hospital OPD building,2nd floor, room number 206. 09356823568 doc.sanchita@gmail.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Committee, Staff research and society, Lokmanya Tilak Municipal Medical college and hospital Status Not Applicable Health Type Patients Approved 01/02/2012 No Date No Date Specified Condition patients suffering from various psychiatric disorders for whom electroconvulsive therapy (ECT)is advised by the psychiatrist Type Details Comparator Agent Normal saline as Placebo Each patient who is to receive five ECTs in five different sittings are enrolled in the study. Apart from the intervention listed below, each patient will receive normal saline as placebo. The patients will receive an intravenous infusion of 50 ml Normal Saline over 10 min followed by a bolus of 10 ml Normal saline over 15 seconds. Intervention Dexmedetomidine 1microgram/kg The patients will receive an intravenous infusion of page 2 / 5
Inclusion Criteria Intervention Dexmedetomidine 0.5microgram/kg Dexmedetomidine 1mcg/kg over 10 min followed by bolus of 10ml normal saline over 15 minutes before induction of anesthesia. The patients will receive an intravenous infusion of Dexmedetomidine 0.5mcg/kg over 10 min followed by a bolus of 10 ml NS over 15 seconds before induction of anesthesia Intervention Esmolol 1mg/kg The patients will receive an intravenous infusion of 50 ml NS over 10 min followed by a bolus of Esmolol (1mg/kg) in 10 ml NS over 15 seconds before induction of anaesthesia. Intervention Lignocaine 1mg/kg The patients will receive an intravenous infusion of 50 ml NS over 10 min followed by a bolus of lignocaine (1mg/kg) in 10 ml NS over 15 seconds before induction of anaesthesia. Age From Age To Gender Details 18.00 Year(s) 60.00 Year(s) Both Inclusion Criteria 1.ASA grade I/II 2.Patients of either sex. 3.Age between 18-60 years. 4.Patients undergoing ECT in general anaesthesia who advised atleast five ECTS. 5.Patients consenting for the study Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Details Computer generated randomization Exclusion Criteria Sequentially numbered, sealed, opaque envelopes Participant, Investigator and Outcome Assessor Blinded 1.ASA grade III/IV 2.BMI>30 3.Known sensitivity to General Anaesthetic drugs. 4.Known allergy to study drugs. 5.Pregnant and lactating females. 6.Patients on beta blockers or calcium channel blockers. 7.Known Hypertensives on treatment. 8.Bronchospasm or bronchial asthma. 9.Systolic BP 10.Heart rate Primary Outcome Outcome Timepoints To compare the effects of two doses of Dexmedetomidine(0.5 and 1mic), Esmolol and Lignocaine during Electroconvulsive therapy under general anaesthesia in terms of Intraoperative hemodynamics (heart rate, blood pressure, rate pressure product). at baseline, after study drug, after induction of anaesthesia, and at 1, 3, 10 minutes after ECT. page 3 / 5
Secondary Outcome Outcome Timepoints 1.Duration of motor seizure. 2.Time to spontaneous breathing, eye opening and obeying commands. 3.Post-procedure sedation/agitation. 4.Readiness to discharge. 5.Propofol requirement. all this will be noted at the end of the ECT session upto discharge. Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=30 Sample Size from =30 Post Marketing Surveillance 02/02/2012 No Date Specified Years=0 Months=3 Days=0 Not Applicable Completed 2. Begec Z., Toprak H. I., Demirbilek S. et al; Dexmedetomidine blunts acute hyperdynamic responses to electroconvulsive therapy without altering seizure duration; ActaAnaesthesiologicaScandinavica, February 2008; 52(2): 302 306. Electroconvulsive therapy (ECT) is frequently used for treatment of psychiatric illness, primarily major affective disorders, and in certain cases of schizophrenia. This therapy works by electrically inducing grand mal seizures. ECT is known for its well-described, brief parasympathetic sequence followed by adrenergic outflow during the seizure, which markedly increases heart rate (HR), arterial blood pressure, and plasma levels of catecholamines. These haemodynamic effects can produce cardiovascular stress and could place a patient with coronary or cerebrovascular disease at the risk of myocardial ischaemia/infarction, congestive heart failure, cardiac arrest or cerebrovascular accidents. A number of drug regimens have been used to prevent or to attenuate the hemodynamic response to ECT. Few of these suggested regimens include NItroglycerin, Lignocaine, opioids such as Fentanyl, adrenoceptor antagonists such as Labetalol, Esmolol, centrally acting α-receptor agonists Clonidine and page 4 / 5
Powered by TCPDF (www.tcpdf.org) Dexmedetomidine. ECTs are frequently performed on an outpatient basis; therefore, anaesthetic drugs used for the procedure should be short-acting with rapid recovery profiles. In addition, several of these drugs cause post-procedure sedation and can prolong time to discharge or cognitive recovery. Thus, although it is desirable to prevent the cardiovascular responses to ECT, the choice of a premedication to accomplish this should be appropriate. In the present study, we plan to compare the effects of Esmolol, lignocaine and two doses of Dexmedetomidine on hemodynamic response to Electroconvulsive therapy under general anaesthesia using a double blind, randomized, placebo-controlled, crossover design. Each patient will receive each of the treatments and will serve as his or her own control. page 5 / 5