Comparison of Propofol and Ketofol as Induction Agents for Electroconvulsive Therapy

NCT07273851 | Completed

• 1 other identifier: FFH-PropKet-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Propofol Ketofol Electroconvulsive Therapy Anesthesia Hemodynamic Stability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Propofol group

ACTIVE COMPARATOR

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

Ketofol group

ACTIVE COMPARATOR

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

Interventions

Propofol 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.

Propofol group

Ketofol 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.

Ketofol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years
• Both genders
• ASA physical status I-II
• Scheduled for electroconvulsive therapy

You may not qualify if:

• History of chronic opioid therapy
• Pregnancy
• Known allergy or hypersensitivity to propofol or ketamine
• History of cardiovascular disease
• History of renal disease

Sponsors & Collaborators

• Fauji Foundation Hospital: lead

Study Sites (1)

Department of Anesthesia, Fauji Foundation Hospital, Rawalpindi, Pakistan

Rawalpindi, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 33718905 BACKGROUND

• 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.

  PMID: 35706636 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22743378 BACKGROUND

• 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.

  PMID: 32454816 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Propofol

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 10, 2025
• Study Start: July 1, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 10, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)