Comparison of Propofol and Ketofol as Induction Agents for Electroconvulsive Therapy

A Randomized Controlled Trial Comparing Propofol and Ketofol for Hemodynamic Stability During Electroconvulsive Therapy

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Propofol; Drug: Ketofol

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Rawalpindi, Pakistan
    • Department of Anesthesia, Fauji Foundation Hospital, Rawalpindi, Pakistan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Systolic Blood Pressure 20 Minutes After Electroconvulsive Therapy	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.	20 minutes after seizure stimulus during the index ECT session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate at 20 Minutes Post-ECT	Heart rate will be measured at baseline, immediately after ECT, and 20 minutes post-shock to compare cardiovascular response between the two groups.	20 minutes post-ECT
Seizure Duration	Duration of the ECT-induced seizure will be measured in seconds using EEG tracing or motor observation from the time of electrical stimulus until cessation of seizure activity.	Immediately following ECT
Recovery Time	Time in minutes from the completion of ECT to spontaneous respiration and recovery of consciousness (Aldrete score ≥ 9) will be recorded to assess recovery profile.	Up to 30 minutes after ECT
Incidence of Hypotension	The occurrence of hypotension (defined as a ≥20% decrease from baseline mean arterial pressure) during or after ECT will be documented and compared between groups.	From induction until 30 minutes post-ECT
Oxygen Saturation (SpO₂)	Minimum oxygen saturation will be monitored continuously using pulse oximetry and recorded to identify any desaturation episodes during and after ECT.	Baseline, intra-procedure, and up to 30 minutes post-ECT
Adverse Events	Any adverse event such as nausea, vomiting, arrhythmia, emergence agitation, or hallucination will be recorded and compared between the two study arms.	Intraoperative period and recovery up to 30 minutes post-ECT

Collaborators and Investigators

• Sponsor: Fauji Foundation Hospital

Publications and helpful links

General Publications

• Smischney NJ, Beach ML, Loftus RW, Dodds TM, Koff MD. Ketamine/propofol admixture (ketofol) is associated with improved hemodynamics as an induction agent: a randomized, controlled trial. J Trauma Acute Care Surg. 2012 Jul;73(1):94-101. doi: 10.1097/TA.0b013e318250cdb8.
• Ikiz C, Gunenc F, Iyilikci L, Ozbilgin S, Ellidokuz H, Cimilli C, Mermi Z, Gokel E. Effects of Propofol and Propofol-Remifentanil Combinations on Haemodynamics, Seizure Duration and Recovery during Electroconvulsive Therapy. Turk J Anaesthesiol Reanim. 2021 Feb;49(1):44-51. doi: 10.5152/TJAR.2020.157. Epub 2020 Dec 16.
• Mehta D, Palta S, Gupta N, Saroa R. Comparison of effect of etomidate with propofol on hemodynamics during modified electroconvulsive therapy. J Anaesthesiol Clin Pharmacol. 2022 Jan-Mar;38(1):104-110. doi: 10.4103/joacp.JOACP_185_20. Epub 2022 Apr 25.
• Guha D, Sheshadri K, Singh S, Bhan S. Efficacy of propofol versus ketamine in modified electroconvulsive therapy: a prospective randomized control trial. J Acute Dis. 2022;11(3):89-93.
• Smischney NJ, Seisa MO, Morrow AS, Ponce OJ, Wang Z, Alzuabi M, Heise KJ, Murad MH. Effect of Ketamine/Propofol Admixture on Peri-Induction Hemodynamics: A Systematic Review and Meta-Analysis. Anesthesiol Res Pract. 2020 May 8;2020:9637412. doi: 10.1155/2020/9637412. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): December 10, 2025
• Study Completion (Actual): December 10, 2025

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Estimated): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Propofol Ketofol Electroconvulsive Therapy Anesthesia Hemodynamic Stability
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol
• Other Study ID Numbers: FFH-PropKet-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No