We are trying to assess the effect of mixture of Propofol and ketamine drugs which is being used during lumbar spinal vertebra surgery on patient’s depression after the surgery

EVALUATION OF THE ROLE OF ketamine-propofol mixture (KETOFOL) as anaesthetic maintenance agents on post operative depression in patient undergoing lumbar fusion surgery: a double blind randomised controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/063294

Enrollment

320

Registered

2024-02-29

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: 8- Other Procedures

Interventions

Intervention1: Ketamine plus propofol infusion: Ketamine 2 ml of 50mg per ml (100 mg) + 40 ml of Propofol 1% (40 mg)+ 8ml normal saline to be loaded in total 50 ml in a syringe Rate of infusion in bot

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of either sex 2.American Society Anaesthesiologists’ physical status I- II, 3.Age between 18 and 65 years, 4.Scheduled for elective lumbar fusion surgical procedures requiring general anaesthesia

Exclusion criteria

Exclusion criteria: Patient refusal, known depression or antidepressant drugs, coronary artery disease, chronic renal and hepatic insufficiency, allergy to study drugs, history of seizure or psychiatric disorder, history of alcohol or substance abuse, antipsychotics, anticonvulsants, and Pregnancy

Design outcomes

Primary

Measure	Time frame
Incidence of depression after lumbar fusion surgery using Beck Depression Inventory-II (BDI-II) Timepoint: At the time of discharge, at 1 month and 3 months	—

Secondary

Measure	Time frame
1.Severity of depression 2.Postoperative recovery (QoR 15 score) 3.Postoperative pain assessment (VAS score) 4.Postoperative cognitive function? (CAM ICU) 5.Adverse drug reactions- (postoperative nausea and vomiting [PONV], nightmare, dizziness, blurred vision, dissociation and delirium) Timepoint: 1.Severity of depression- At the time of discharge, at 1 month and 3 months 2.Pain score at 24 hours 3.QoR-at the time of discharge, and, at 1 month and 3 months 4.Postoperative cognitive function? (CAM ICU) at 24 hr and at 48 hrs 5.Adverse drug reactions at 24 hours	—

Measure

Time frame

1.Severity of depression 2.Postoperative recovery (QoR 15 score) 3.Postoperative pain assessment (VAS score) 4.Postoperative cognitive function? (CAM ICU) 5.Adverse drug reactions- (postoperative nausea and vomiting [PONV], nightmare, dizziness, blurred vision, dissociation and delirium) Timepoint: 1.Severity of depression- At the time of discharge, at 1 month and 3 months 2.Pain score at 24 hours 3.QoR-at the time of discharge, and, at 1 month and 3 months 4.Postoperative cognitive function? (CAM ICU) at 24 hr and at 48 hrs 5.Adverse drug reactions at 24 hours

—

Countries

India

Contacts

Public ContactDr Devendra Gupta

Sanjay Gandhi Post Graduate Institute of Medical Sciences Lucknow

drdevendragpt@yahoo.com8004904596

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026