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AzTrials

Major Depressive DisorderNCT07273851

Comparison of Propofol and Ketofol as Induction Agents for Electroconvulsive Therapy

A study testing Propofol and Ketofol in people with Major Depressive Disorder, run by Fauji Foundation Hospital at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Propofol and Ketofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 sitePakistan
Study dates
1 Jul 2025to 10 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

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

    Rawalpindi

Other trials in Pakistan

About this study

Official title: 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.

Read the 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.

Being tested
Propofol, Ketofol
Keywords
Propofol Ketofol Electroconvulsive Therapy Anesthesia Hemodynamic Stability
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    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.

  • KetofolDrug

    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.

Study groups in NCT07273851
Study groupRoleWhat they receive
Propofol groupActive comparatorParticipants 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.
Receives: Drug: Propofol
Ketofol groupActive comparatorParticipants 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.
Receives: Drug: Ketofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 20 minutes after seizure stimulus during the index ECT session

Secondary outcomes (6)

  1. 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.

    Measured: 20 minutes post-ECT

  2. 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.

    Measured: Immediately following ECT

  3. 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.

    Measured: Up to 30 minutes after ECT

  4. 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.

    Measured: From induction until 30 minutes post-ECT

  5. Oxygen Saturation (SpO₂)

    Minimum oxygen saturation will be monitored continuously using pulse oximetry and recorded to identify any desaturation episodes during and after ECT.

    Measured: Baseline, intra-procedure, and up to 30 minutes post-ECT

  6. Adverse Events

    Any adverse event such as nausea, vomiting, arrhythmia, emergence agitation, or hallucination will be recorded and compared between the two study arms.

    Measured: Intraoperative period and recovery up to 30 minutes post-ECT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2025
  2. Study start1 Jul 2025
  3. Primary completion10 Dec 2025
  4. Study completion10 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07273851
Sponsor's protocol ID
FFH-PropKet-01
Status last verified
Dec 2025
First submitted
18 Nov 2025
Last updated
12 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33718905

  • 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.

    PubMed 35706636

  • 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, 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.

    PubMed 22743378

  • 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.

    PubMed 32454816

Questions about this trial

What is this clinical trial studying?

A study testing Propofol and Ketofol in people with Major Depressive Disorder, run by Fauji Foundation Hospital at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Systolic Blood Pressure 20 Minutes After Electroconvulsive Therapy (time frame: 20 minutes after seizure stimulus during the index ECT session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07273851, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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