Comparison of Propofol and Ketofol as Induction Agents for Electroconvulsive Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-12-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Intravenous induction agent administered before electroconvulsive therapy. Participants in this arm will receive IV propofol 1 mg/kg as a single slow bolus immediately before ECT under continuous ECG, pulse oximetry, and non-invasive blood pressure monitoring. Premedication with glycopyrrolate 0.004 mg/kg IV will be given to all patients. Ringer's lactate infusion will begin prior to induction. After loss of eyelash reflex, ECT will be performed using bifrontotemporal electrodes. Systolic blood pressure, heart rate, and oxygen saturation will be recorded at baseline and 20 minutes after shock delivery. The patient will be ventilated with 100 % oxygen until spontaneous breathing resumes.

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.

Group Type ACTIVE_COMPARATOR

Ketofol

Intervention Type DRUG

Intravenous admixture prepared immediately before induction by combining equal parts of ketamine and propofol in the same syringe. Participants will receive propofol 0.5 mg/kg + ketamine 0.5 mg/kg as a slow IV bolus immediately before ECT. Continuous ECG, pulse oximetry, and non-invasive blood pressure monitoring will be maintained. Premedication and procedural steps are identical to the propofol arm. The rationale is that ketamine's sympathetic stimulation counterbalances the hypotensive effect of propofol, potentially improving hemodynamic stability during ECT. Hemodynamic variables and seizure duration will be documented at baseline, during, and 20 minutes after shock delivery. Patients will receive 100 % oxygen ventilation until spontaneous respiration resumes.

Interventions

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Propofol

Intravenous induction agent administered before electroconvulsive therapy. Participants in this arm will receive IV propofol 1 mg/kg as a single slow bolus immediately before ECT under continuous ECG, pulse oximetry, and non-invasive blood pressure monitoring. Premedication with glycopyrrolate 0.004 mg/kg IV will be given to all patients. Ringer's lactate infusion will begin prior to induction. After loss of eyelash reflex, ECT will be performed using bifrontotemporal electrodes. Systolic blood pressure, heart rate, and oxygen saturation will be recorded at baseline and 20 minutes after shock delivery. The patient will be ventilated with 100 % oxygen until spontaneous breathing resumes.

Intervention Type DRUG

Ketofol

Intravenous admixture prepared immediately before induction by combining equal parts of ketamine and propofol in the same syringe. Participants will receive propofol 0.5 mg/kg + ketamine 0.5 mg/kg as a slow IV bolus immediately before ECT. Continuous ECG, pulse oximetry, and non-invasive blood pressure monitoring will be maintained. Premedication and procedural steps are identical to the propofol arm. The rationale is that ketamine's sympathetic stimulation counterbalances the hypotensive effect of propofol, potentially improving hemodynamic stability during ECT. Hemodynamic variables and seizure duration will be documented at baseline, during, and 20 minutes after shock delivery. Patients will receive 100 % oxygen ventilation until spontaneous respiration resumes.

Intervention Type DRUG

Eligibility Criteria

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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

Pregnancy

Known allergy or hypersensitivity to propofol or ketamine

History of cardiovascular disease

History of renal disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No