NCT05305313 Evaluation of Propofol Dosing Based on Total Body Weight Using Closes-loop Anaesthesia Delivery System
| NCT ID | NCT05305313 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sir Ganga Ram Hospital |
| Condition | Obesity, Morbid |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2022-04-19 |
| Primary Completion | 2027-11-04 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 46 participants in total. It began in 2022-04-19 with a primary completion date of 2027-11-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The pharmacokinetic profile of various drugs is altered in obese patients especially those administered by the intravenous route. Propofol is the commonly used intravenous anesthetic agent for induction and maintenance of anaesthesia as part of total intravenous anaesthesia (TIVA) regimen. A major concern with propofol dosing based on total body weight (TBW) in obese patients is disproportionate drug administration leading to undue drug accumulation in body with a potential to overdosing, delayed recovery from anaesthesia, and adverse hemodynamic outcome. Studies on propofol dosing based on various weight scalars have recommended that lean body weight (LBW) should be used for calculating bolus dose during anaesthesia induction and TBW or adjusted body weight (ABW) for arriving at an infusion dose required for maintenance of anesthesia. Although propofol delivery based on dose calculated by TBW has been well researched the evidence for propofol delivery based on dose calculated by ABW is lacking. Recent advance in the delivery of propofol has been the development of computer controlled anaesthesia delivery systems. These devices deliver propofol based on patient's frontal cortex electrical activity as determined by bispectral index (BIS). Evaluation of anaesthesia delivery by these systems has shown that they deliver propofol and maintain depth of anaesthesia with far more precision as compared to manual administration. One such indigenously developed computer controlled anaesthesia delivery system is the closed loop anesthesia delivery system (CLADS). CLADS functions on control of processed EEG response parameter captured from anesthetized patients with the help of a BIS- monitor, which is continuously fed into an automated drug infusion pump. The infusion pump then accordingly delivers the anesthetic drug to the patients based on pharmacodynamic requirements. The investigators plan to evaluate the propofol maintenance dose requirement based on TBW versus ABW using CLADS for propofol delivery.
Eligibility Criteria
Inclusion Criteria: 1. ASA physical status II/III 2. laparoscopic and non-laparoscopic surgery of more than 60-minutes duration 3. Body mass index \> 35kg/m2 Exclusion Criteria: 1. Cardiovascular disorders (uncontrolled hypertension, Atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance \& diastolic dysfunction) 2. Neurological disorders (previous neurosurgery, psychiatric disorders, autonomic nervous system disorders- orthostatic hypotension, transient ischemic attacks) 3. Hepato-renal insufficiency 4. Uncontrolled diabetes mellitus 5. Known allergy/hypersensitivity to study drug 6. Pulmonary dysfunction (restrictive /obstructive lung disease) 7. Acute/chronic drug dependence/substance abuse
Contact & Investigator
Goverdhan D Puri, MD, PhD
STUDY DIRECTOR
Post Graduate Institute of Medical Education & Research, Chandigarh, India
Frequently Asked Questions
Who can join the NCT05305313 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obesity, Morbid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05305313 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05305313 currently recruiting?
Yes, NCT05305313 is actively recruiting participants. Contact the research team at nitinsethi77@yahoo.co.in for enrollment information.
Where is the NCT05305313 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT05305313 clinical trial?
NCT05305313 is sponsored by Sir Ganga Ram Hospital. The principal investigator is Goverdhan D Puri, MD, PhD at Post Graduate Institute of Medical Education & Research, Chandigarh, India. The trial plans to enroll 46 participants.
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