| CTRI Number |
CTRI/2018/08/015218 [Registered on: 07/08/2018] Trial Registered Prospectively |
| Last Modified On: |
06/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two anesthetic agents in electric shock therapy for psychiatric illnesses |
|
Scientific Title of Study
|
A Comparative Study of Etomidate and Propofol as Induction Agents in Modified Electroconvulsive Therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samiksha kumari |
| Designation |
junior resident |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
Shaheed Bhagat Singh Nagar
Near Khadi Bhandar
PO-Sujanpur
Teh n Distt.- Pathankot
Gurdaspur
PUNJAB
145023
India |
| Phone |
9876922625 |
| Fax |
|
| Email |
drsamiksha309@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Jindal |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
Dr Seema Jindal
H.no. 42
GGS Medical Campus
Sadiq Road, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
7986514858 |
| Fax |
|
| Email |
jindalseema77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Jindal |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
Dr Seema Jindal
H.no. 42
GGS Medical Campus
Sadiq Road, Faridkot
Bathinda
PUNJAB
151203
India |
| Phone |
7986514858 |
| Fax |
|
| Email |
jindalseema77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Gobind Singh Medical College and Hospital, Faridkot |
|
|
Primary Sponsor
|
| Name |
Samiksha kumari |
| Address |
Shaheed Bhagat Singh Nagar
Near Khadi Bhandar
P0-Sujanpur
Teh n distt.-Pathankot
Pin-145023 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Samiksha Kumari |
Guru Gobind Singh hospital Faridkot |
Department of Anesthesia
Guru Gobind Singh Medical College and Hospital, Faridkot
pin-145023
Faridkot
PUNJAB |
9876922625
drsamiksha309@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Gobind Singh Medical College and Hospital Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Psychiatric patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ETOMIDATE |
Induction agent
Dose 0.2 mg/kg iv adminidtration
Frequency depends on therapeutic response (as decided by physician) |
| Intervention |
PROPOFOL |
induction agent
Dose 1 mg/kg iintra-venous administration
Frequency depends on therapeutic response (as decided by physician)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Adult patients of equal number of males and females, aged between 18 to 55 years.
2) Patients belonging to American Society of Anesthesiologist Grade I and II.
3) Patients scheduled for electroconvulsive therapy.
|
|
| ExclusionCriteria |
| Details |
1) Patient or relatives refusal for electroconvulsive therapy or both.
2) Patients with known allergy to the study drug.
3) Patients with full stomach, neuromuscular disorders, displaced bone fractures, severe osteoporosis.
4) Patients with history of recent myocardial infarction (<3 months), recent cerebrovascular accident or raised ICP.
5) Patients with epilepsy
6) Patients with hypopituitarism and major illnesses like bronchial asthma and tuberculosis.
7) Pregnant patients.
8) Agitated patients requiring additional sedation.
9) ASA grade III and IV patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of motor seizure duration in isolated limb in seconds for both the drugs |
Measurement of motor seizure duration in isolated limb in seconds just after giving electric shock for both the drugs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Recovery parameters
Any side effects |
Intra-operatively and after every 5 min after the procedure |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A COMPARATIVE STUDY
OF ETOMIDATE AND
PROPOFOL AS INDUCTION
AGENTS IN MODIFIED
ELECTROCONVULSIVE THERAPY
INTRODUCTION: Modified ECT is used in refractory psychiatric illnesses
with anaesthesia to avoid trauma to the patient physically and psychologically.
Propofol and etomidate are short acting iv anaesthetic agents used in ECT.
AIMS AND OBJECTIVES: 1) To study
propofol in terms of induction time, motor seizure duration, hemodynamic
parameters, recovery time and adverse effects. 2)To study etomidate in terms of induction time, motor seizure duration, hemodynamic
parameters, recovery time and adverse effects. 3)Comparison of propofol and etomidate in terms of induction time, motor
seizure duration, hemodynamic parameters, recovery time, adverse effects in
modified electroconvulsive therapy.
MATERIAL AND METHODS: The study will be conducted in
Department of Anaesthesiology, GGS Medical College, Faridkot. INCLUSION CRITERIA 1)Adult
patients of equal number of males and females, aged between 18 and 55 years. 2)Patients
belonging to American Society of Anesthesiologist Grade I and II. 3)Patients
scheduled for electroconvulsive therapy. EXCLUSION
CRITERIA 1)Patient
or relatives refusal for electroconvulsive therapy or both. 2)Patients with known allergy to the
study drug. 3)Patients with full stomach,
neuromuscular disorders, displaced bone fractures, severe osteoporosis.
3)Patients with history of recent myocardial infarction (<3 months), recent
cerebrovascular accident or raised ICP. 4)Patients with epilepsy 5)Patients
with hypopituitarism and major illnesses like bronchial asthma and
tuberculosis. 6)Pregnant patients. 7)Agitated patients requiring additional
sedation. 7)ASA grade III and IV patients.
Written
informed consent will be obtained from each patient. 70 patients scheduled for
electroconvulsive therapy at Department of Anaesthesia, GGSMCH, Faridkot will
be randomly assigned to one of two general anaesthetic groups.
Group
A patients will recieve propofol 1.0 mg/kg and Group B patients will receive etomidate
0.2 mg/kg as induction agents respectively and motor seizure duration of the
two drugs will be measured.
Intra
–operatively, motor seizure duration, induction time, hemodynamic and recovery
parameters and any adverse effects will be noted. Following ECT, patients will
be assessed by patient satisfaction score and emergence agitation score. |