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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
 
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