(1) Objective: Comparison the effect of Propofol, Etomidate and Thiopental on seizure duration following Electroconvulsive Therapy.
(2) Design: Single blind clinical trial study.
(3) Setting and conduct: Selecting 90 patients need to be treated by ECT in psychiatric unit of 5 Azar tertiary hospital affiliated to Golestan University of Medical Sciences and assigning them to three groups by simple random allocation method.
(4) Participants including major eligibility criteria: Inclusion Criteria: Age between 15 to 50 years; Having psychiatric disorders based on DSM-IV diagnostic criteria and indication for ECT according to psychologist`s opinion. Exclusion Criteria: Having cardiovascular diseases and hypertension; Using medications affecting the duration of seizure; and Contraindication for ECT.
(5) Interventions: Standard monitoring and pre-oxygenation with 100% FiO2 for 3 minutes for all patients in three groups; Anesthesia of the patients in the first, second, and third group with Thiopental (1.5 mg/kg), Etomidate (0.1 mg/kg), and Propofol (0.6 mg/kg), respectively; Administration of Succinyl Colin (0.5 mg/kg) as muscle relaxant and Atropine for prevention of bradycardia in all patients.
(6) Main outcome measures (variable): Duration of seizure and recovery; changes in hemodynamic status such as heart rate and mean arterial pressure; and amount of charge for ECT.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071135021N1
Registration date:2017-08-13, 1396/05/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Ramin Amini
Name of organization / entity
Golestan university of Medical Sciences, Gorgan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 17 3235 4936
Email address
r.amini@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Golestan University of Medical Sciences, Gorgan, Iran
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Propofol, Etomidate and Thiopental on Seizure Duration following Electroconvulsive Therapy
Public title
Comparison the Effect of Propofol, Etomidate and Thiopental on Seizure following Electroconvulsive Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age between 15 to 50 years; Having psychiatric disorders based on DSM-IV diagnostic criteria and indication for ECT according to psychologist`s opinion. Exclusion Criteria: Having cardiovascular diseases and hypertension; Using medications affecting the duration of seizure; and Contraindication for ECT.
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Shastkola road, Falsafi Educational Campus of Golestan University of Medical Sciences, Gorgan, Golestan province, Iran
City
Gorgan
Postal code
4934174515
Approval date
2017-02-12, 1395/11/24
Ethics committee reference number
IR.goums.REC1395.240
Health conditions studied
1
Description of health condition studied
Seizure
ICD-10 code
G40.6
ICD-10 code description
Grandmal seizures, unspecified (with or without petit mal
Primary outcomes
1
Description
Duration of Seizure
Timepoint
Following ECT, from beginning of seizure to end of it.
Method of measurement
by chronometer in second
Secondary outcomes
1
Description
Duration of Recovery
Timepoint
Recovery of consciousness after induction of anesthesia
Method of measurement
By chronometer in second
2
Description
changes of hemodynamic parameters including heart rate in beat per minute and mean arterial pressure in millimeter mercury according to systolic and diastolic blood pressure
Timepoint
During the study
Method of measurement
Recording of the non-invasive hemodynamic monitoring device
3
Description
Amount of charge for ECT
Timepoint
During setting up the ECT device
Method of measurement
Observation of the ECT Device Settings
Intervention groups
1
Description
Third intervention group: standard monitoring and pre-oxygenation with 100% FiO2 for 3 minutes; Anesthesia with intravenous Propofol (0.6 mg/kg); Administration of intravenous Succinyl Colin (0.5 mg/kg) as muscle relaxant and intravenous Atropine (0.1 mg/kg) for prevention of bradycardia
Category
Treatment - Drugs
2
Description
First intervention group: standard monitoring and pre-oxygenation with 100% FiO2 for 3 minutes; Anesthesia with intravenous Thiopental (1.5 mg/kg); Administration of intravenous Succinyl Colin (0.5 mg/kg) as muscle relaxant and intravenous Atropine (0.1 mg/kg) for prevention of bradycardia.
Category
Treatment - Drugs
3
Description
Second intervention group: standard monitoring and pre-oxygenation with 100% FiO2 for 3 minutes; Anesthesia with intravenous Etomidate (0.1 mg/kg); Administration of intravenous Succinyl Colin (0.5 mg/kg) as muscle relaxant and intravenous Atropine for prevention of bradycardia.