Low-dose ketamine to improve consistency of anesthetic depth
Effect of Subanaesthetic Dose of Ketamine on Depth of Anaesthesia Consistency During Propofol Total Intravenous Anaesthesia Administered by Closed-loop Anaesthesia Delivery System in Adults Undergoing Elective Laparoscopic Surgery: a Randomised Controlled Study
This study will test whether adding a small dose of ketamine to propofol makes the depth of general anesthesia more consistent for adults having elective laparoscopic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sir Ganga Ram Hospital Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT06986109 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for elective laparoscopic surgery lasting more than 60 minutes receive propofol total intravenous anesthesia (TIVA) combined with either a subanesthetic dose of ketamine or a placebo while clinical parameters are recorded. Depth of anesthesia will be monitored using the Bispectral Index (BIS) and a closed-loop anesthesia delivery system to measure variability and consistency of sedation. The trial excludes patients with significant cardiovascular, hepatic, renal, psychiatric, endocrine disorders, recent sedative use, substance abuse, or anticipated postoperative ventilation. Outcomes compare BIS variability and stability between the ketamine and placebo groups to see if ketamine reduces fluctuations in anesthetic depth.
Who should consider this trial
Good fit: Adults (ASA I–II) scheduled for elective laparoscopic surgery expected to last over 60 minutes and without major organ dysfunction or psychiatric disease.
Not a fit: Patients with uncontrolled cardiovascular, liver, kidney, endocrine, or psychiatric disease, recent sedative or antipsychotic use, substance abuse, or those who need postoperative ventilation are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, adding low-dose ketamine could produce more stable anesthetic depth, potentially reducing episodes of under- or over-sedation and improving patient safety and recovery.
How similar studies have performed: Previous work has shown ketamine can alter EEG patterns and provide analgesic benefits as an adjuvant to propofol, but its specific effect on BIS consistency within closed-loop TIVA systems is not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA physical status I and II. * Patients scheduled for elective laparoscopic surgery with estimated duration greater than 60-minutes. Exclusion Criteria: * Known uncontrolled cardiovascular disease (e.g., hypertension, systolic and diastolic dysfunction) * Liver function abnormality (liver enzymes \>2 times the normal range) * Kidney function abnormality (serum creatinine \>1.4 mg/dl) * Known psychiatric or neurological disorder * Known uncontrolled endocrine disorder (diabetes mellitus, hypothyroidism) * Known allergy or hypersensitivity to the study drug * Recent intake of sedative medication or anti-psychotic medication * Substance abuse * Anticipated need for postoperative ventilation * Refusal to informed consent
Where this trial is running
New Delhi, National Capital Territory of Delhi
- Sir Ganga Ram Hospital — New Delhi, National Capital Territory of Delhi, India (Recruiting)
Study contacts
- Study coordinator: Nitin Sethi, DNB
- Email: nitinsethi77@yahoo.co.in
- Phone: 00919717494498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.