A Randomized Controlled Trial Comparing Propofol and Ketofol for Hemodynamic Stability During Electroconvulsive Therapy
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fauji Foundation Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Mean Systolic Blood Pressure 20 Minutes After Electroconvulsive Therapy
Overview
Brief Summary
This randomized controlled trial will compare two anesthetic agents, propofol and ketofol (a combination of propofol and ketamine), in patients undergoing electroconvulsive therapy (ECT). Propofol is commonly used but may lower blood pressure, while ketofol may help maintain more stable cardiovascular function. The study will evaluate changes in systolic blood pressure following ECT when either propofol or ketofol is used for anesthesia induction. A total of 80 adult patients will be enrolled and randomly assigned to one of the two treatment groups. Findings may guide anesthesiologists in selecting the safest and most effective induction agent for ECT.
Detailed Description
Electroconvulsive therapy (ECT) is an established treatment for depression and other psychiatric disorders that do not respond to medications. The procedure requires short-term anesthesia. Propofol is the most commonly used drug for anesthesia during ECT because it acts quickly and allows patients to recover rapidly, but it is often linked with low blood pressure and shorter seizure duration. Ketamine, another anesthetic drug, increases blood pressure and heart rate and may prolong seizures, but it is rarely used alone because of side effects such as agitation.
A newer approach is to combine both drugs, known as ketofol, to balance their effects. This study will directly compare propofol and ketofol as induction agents during ECT, with a focus on how each affects systolic blood pressure. Eighty adult patients scheduled for ECT will be randomly assigned to receive either propofol or ketofol for anesthesia. Blood pressure will be measured before and after the procedure, and additional information such as seizure duration, recovery time, and side effects will be recorded. The results will provide evidence on whether ketofol offers better hemodynamic stability than propofol alone, potentially improving safety during ECT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18-65 years
- •Both genders
- •ASA physical status I-II
- •Scheduled for electroconvulsive therapy
Exclusion Criteria
- •History of chronic opioid therapy
- •Known allergy or hypersensitivity to propofol or ketamine
- •History of cardiovascular disease
- •History of renal disease
Arms & Interventions
Propofol group
Participants receive intravenous propofol (1 mg/kg) as the induction agent for modified electroconvulsive therapy (ECT). Glycopyrrolate (0.004 mg/kg) is given as premedication, and Ringer's lactate is started before induction. ECT is performed using bifrontotemporal electrodes under standard monitoring. Systolic blood pressure is recorded 20 minutes after shock delivery.
Intervention: Propofol (Drug)
Ketofol group
Participants receive ketofol (a 1:1 mixture of ketamine and propofol) as the induction agent for modified ECT. Ketofol is prepared by mixing propofol 0.5 mg/kg and ketamine 0.5 mg/kg in the same syringe. Standard premedication and monitoring apply. Systolic blood pressure is recorded 20 minutes after shock delivery.
Intervention: Ketofol (Drug)
Outcomes
Primary Outcomes
Mean Systolic Blood Pressure 20 Minutes After Electroconvulsive Therapy
Time Frame: 20 minutes after seizure stimulus during the index ECT session
Systolic blood pressure (SBP) will be recorded 20 minutes after the delivery of electrical stimulus in both study groups using a non-invasive blood pressure monitor. Baseline SBP will also be recorded prior to induction. The mean SBP between propofol and ketofol groups will be compared to determine the effect of anesthetic agent on post-ECT hemodynamic stability.
Secondary Outcomes
- Heart Rate at 20 Minutes Post-ECT(20 minutes post-ECT)
- Seizure Duration(Immediately following ECT)
- Recovery Time(Up to 30 minutes after ECT)
- Incidence of Hypotension(From induction until 30 minutes post-ECT)
- Oxygen Saturation (SpO₂)(Baseline, intra-procedure, and up to 30 minutes post-ECT)
- Adverse Events(Intraoperative period and recovery up to 30 minutes post-ECT)