Comparison of TIVA by Closed Loop Anaesthesia Delivery System Versus Target Controlled Infusion Device
Launched by SIR GANGA RAM HOSPITAL · Jan 28, 2021
Trial Information
Current as of May 08, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different methods of delivering a type of anesthesia called Total Intravenous Anesthesia (TIVA) during non-cardiac surgery. One method uses a Target Controlled Infusion (TCI) device, which delivers a specific amount of medication based on pre-set models. The other method is an automated Closed Loop Anesthesia Delivery System (CLADS) that adjusts the medication based on the patient's brain activity, ensuring a more precise level of anesthesia. The goal is to find out which method maintains appropriate anesthesia depth better and leads to a smoother recovery for patients.
To participate in this trial, you need to be between 18 and 65 years old and in good overall health, meaning you shouldn't have serious heart, liver, or kidney issues, or other uncontrolled medical conditions. The surgery you would be undergoing should last at least 60 minutes. Participants can expect to be randomly assigned to one of the two anesthesia delivery methods and will be monitored throughout the process to assess how well each method works in terms of anesthesia depth and recovery. It's important to know that if you have any allergy to the study drug or refuse to give consent, you won't be eligible to participate.
Gender
ALL
Eligibility 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
About Sir Ganga Ram Hospital
Sir Ganga Ram Hospital is a premier multi-specialty healthcare institution located in New Delhi, India, renowned for its commitment to delivering high-quality patient care and advancing medical research. Established in 1954, the hospital is equipped with state-of-the-art facilities and a team of highly skilled professionals dedicated to clinical excellence. As a clinical trial sponsor, Sir Ganga Ram Hospital actively engages in innovative research initiatives aimed at improving treatment outcomes and enhancing patient safety. Through its robust ethical framework and adherence to regulatory standards, the hospital fosters a collaborative environment for clinical research, contributing to the global medical community's efforts in developing effective therapies and interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Delhi, Delhi, India
New Delhi, Delhi, India
Patients applied
Trial Officials
Jayashree Sood, MBBS, MD, FFRCA, PGDHHM, FICA
Study Chair
Sir Ganga Ram Hospital, New Delhi, INDIA
Goverdhan D Puri, MBBS, MD, PhD
Study Director
Postgraduate Institute for Medical Education & Research, Chandigarh, India
Nitin Sethi, MBBS, DNB
Principal Investigator
Sir Ganga Ram Hospital, New Delhi, INDIA
Amitabh Dutta, MBBS, MD, PGDHR
Principal Investigator
Sir Ganga Ram Hospital, New Delhi, INDIA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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