| CTRI Number |
CTRI/2025/01/079636 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare the effects of varying Doses of Propofol on the heart rate , oxygen saturation and blood pressure in Patients having Electro Convulsive Therapy (ECT) |
|
Scientific Title of Study
|
To Compare the effects of Two Different Doses of Propofol on the Hemodynamic Parameters in Patients Undergoing Electro Convulsive Therapy (ECT) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prachi Pravin Deshmukh |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital |
| Address |
Department of Anaesthesia
Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital,(DMIHER)
Radhikabai PG Girls hostel
Room No G11
Sawangi (Meghe), Wardha MH Pin Code 442001
Wardha MAHARASHTRA 442001 India |
| Phone |
8275783077 |
| Fax |
|
| Email |
prachipdeshmukh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vivek Chakole |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital(DMIHER) |
| Address |
Department of Anaesthesia Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospita(DMIHER)
Sawangi (Meghe), Wardha MH Pin Code 442001
Wardha MAHARASHTRA 442001 India |
| Phone |
7583836564 |
| Fax |
|
| Email |
drvivekchakole@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prachi Pravin Deshmukh |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital |
| Address |
Department of Anaesthesia Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital (DMIHER)
Radhikabai PG girls hostel
Room No G11
Sawangi (Meghe), Wardha MH Pin Code 442001
Wardha MAHARASHTRA 442001 India |
| Phone |
8275783077 |
| Fax |
|
| Email |
prachipdeshmukh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha MH Pin Code 442001 |
|
|
Primary Sponsor
|
| Name |
Anaesthesiology Dept, Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital |
| Address |
Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha MH Pin Code 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Prachi Pravin Deshmukh |
Jawaharlal Nehru Medical College, Acharya Vinoba Bhave Rural Hospital( DMIHER) |
Department of Anaesthesia
Neuroanaesthesia OT
Sawangi (Meghe), Wardha MH Pin Code 442001 Wardha MAHARASHTRA |
8275783077
prachipdeshmukh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research,Jawaharlal Nehru Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electro Convulsive Therapy,
total intravenous Anaesthesia |
To Compare the effects of Two Different Doses of Propofol given in total intravenous anaesthesia on the Hemodynamic Parameters in Patients Undergoing Electro Convulsive Therapy (ECT)
total duration of intervention(ECT) - 20mins |
| Comparator Agent |
Propofol |
1.0 mg/kg, 1.5 mg/kg doses
Comparison
intravenous administration
duration 20mins |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients (20 to 60 years of age )
Either gender Male and Female
Patients included in ASA grade 1 and 2
Patients recommended to receive ECT |
|
| ExclusionCriteria |
| Details |
Patients Refusal
Patients with comorbidities such as hypertension, diabetes, bronchial asthma, tuberculosis, acute respiratory disorders, neuromuscular disorders and cardiovascular disorders.
Secondary diagnosis of a amnestic disorder, dementia, or delirium, or epilepsy.
Pregnancy, Lactation.
History of alcohol or Abuse of substances in the year before the start of the study.
Allergy to drugs (Propofol and Succinylcholine used in the procedure). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lower Dose of drug shows better hemodynamic stability |
Baseline , 1 minute , 3 minutes , 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post-seizure apnea time
Post-electroconvulsive therapy recovery time
Duration of seizures
Quality of seizure |
baseline , 1 minute ,3 minutes, 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| 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="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Since its introduction, Electro Convulsive Therapy (ECT) has been used to treat variety of mental diseases which include treatment-resistant depression, bipolar mood disorder, multi-drug resistance, and depression with psychosis. The aim of ECT is to cure particular mental illnesses by applying an electrical charge or amount of current to the frontal lobe of the brain. Anaesthesia has been a component of ECT treatment since the 1950s. It was then called Modified ECT which included muscle relaxants and general anesthetic to lessen stress on the body and mind. Its goals are to lower hazards both during and after ECT procedures and to ensure patients’ comfort. This procedure included patient getting modified anaesthesia by Anaesthesia team.
The goal of Electro Convulsive Therapy is therapeutic effectiveness. Therapy’s Effectiveness depends on each patient getting ECT having high-quality seizure activity. To be classified as having good quality seizure activity, a patient must have motor seizures that last longer than 15 seconds, electroencephalography (EEG) seizures that last longer than 20 sec, and postictal suppression that is greater than 50%. Among the anesthetic drugs frequently used during Electroconvulsive therapy operations is Propofol. Propofol is an anesthetic induction drug with characteristics like a quick onset of action and a quick recovery. The aim of this study is to compare the results of two distinct dosages of Propofol (1.0 mg/kg and 1.5 mg/kg) on hemodynamic parameters, post-seizure apnea time, post-electroconvulsive therapy recovery time, duration of seizures, and quality of seizures. Patients who get lower dose are expected to experience shorter recovery times, better hemodynamic stability, a shorter time to regain consciousness and reduced anxiety and more positive attitude towards ECT without compromising efficacy.
Keywords: Electro Convulsive Therapy, Anesthesia, Propofol |