Comparing two methods of delivering anesthesia during surgery
Evaluation of Propofol Total Intravenous Anaesthesia Administered by Closed Loop Anaesthesia Delivery System Versus Target Controlled Infusion Device in Adults Undergoing Non-Cardiac Surgery: A Randomised Controlled Study
This study is testing which method of giving anesthesia works better for patients having non-cardiac surgery, to see if one helps them recover more comfortably than the other.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sir Ganga Ram Hospital Academic / other |
| Locations | 2 sites (New Delhi, Delhi and 1 other locations) |
| Trial ID | NCT04731480 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of a closed loop anesthesia delivery system with a target controlled infusion device for administering total intravenous anesthesia (TIVA) using propofol. TIVA is preferred for its benefits, including reduced postoperative nausea and vomiting (PONV) and improved recovery quality. The study aims to evaluate the precision and outcomes of these two delivery methods in patients undergoing elective non-cardiac surgery lasting at least 60 minutes. Participants will be monitored for their response to anesthesia and recovery metrics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with ASA physical status I-II undergoing elective non-cardiac surgery.
Not a fit: Patients with uncontrolled cardiovascular or endocrine diseases, or those requiring postoperative ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance anesthesia delivery, leading to better recovery outcomes and fewer complications for patients.
How similar studies have performed: While the use of TIVA has been established, the specific comparison of closed loop systems versus target controlled infusion devices is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged 18-65 years * ASA physical status I-II * undergoing elective non-cardiac surgery of minimum 60-minutes duration Exclusion Criteria: * Uncompensated cardiovascular disease (e.g. uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction) * Hepato-renal insufficiency * Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism) * Known allergy/hypersensitivity to the study drug * Drug dependence/substance abuse * Requirement of postoperative ventilation * Refusal to informed consent
Where this trial is running
New Delhi, Delhi and 1 other locations
- Nitin Sethi — New Delhi, Delhi, India (Recruiting)
- Sir Ganga Ram Hospital — New Delhi, Delhi, India (Recruiting)
Study contacts
- Principal investigator: Nitin Sethi, MBBS, DNB — Sir Ganga Ram Hospital, New Delhi, INDIA
- Study coordinator: Nitin Sethi, MBBS, DNB
- Email: nitinsethi77@yahoo.co.in
- Phone: 00911142252523
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.