Performance Analysis of Hermetic Closed-loop Anesthesia Delivery System

NCT05967403 | Recruiting DMC

• 1 other identifier: EC/05/23/2282
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Total intravenous anaesthesia (TIVA) is now a preferred technique for providing general anaesthesia (GA) because of its various inherent advantages like reduced postoperative nausea and vomiting (PONV), improved quality of post-operative recovery, anti-inflammatory and antioxidant action, anti-neoplastic activity, analgesic action, and absence of greenhouse effect. The evolution and advancement in automated anaesthesia delivery systems particularly for propofol have made propofol-TIVA more efficient by removing the human interface for both rate and concentration adjustments. Automated computer-controlled closed loop anaesthesia device adjusts propofol delivery based on patient's frontal cortex electrical activity determined by bispectral index (BIS). Closed loop anaesthesia delivery system (CLADS) is an indigenously developed patented (Patent no.502/DEL/2003 \& US 9,108,013 B2) computer-controlled anaesthesia delivery system which works with feedback loop information elicited by BIS monitoring and delivers propofol TIVA to the patient via a non-TCI automated infusion pump. It has been an extensively used and validated in patients undergoing both cardiac and non-cardiac surgical procedures. A new compact and upgraded version of CLADS is now available. This new version incorporates the anesthetic depth monitor, hemodynamic monitor, controller, user interface and actuator syringe pump into a single, compact and user-friendly module. The investigators aim to conduct a prospective randomized pilot study comparing the new CLADS and older CLADS version with respect to: adequacy of anaesthesia depth maintenance, performance characteristic of propofol delivery system, propofol requirement, haemodynamics stability, recovery from anesthesia and postoperative sedation.

Conditions

Anesthesia

Keywords

propofol; closed-loop; anesthesia

Outcome Measures

Primary Outcomes (1)

• Anaesthesia depth consistency

  It will be determined by the percentage of the anaesthesia time during which the BIS remained +/- 10 of the target BIS of 50

  From beginning of anaesthesia till 5- minutes post skin closure

Secondary Outcomes (13)

• Performance characteristic of propofol delivery system

  From beginning of anaesthesia till 5- minutes post skin closure

• Performance characteristic of propofol delivery system

  From start of anesthesia till 5- minutes post skin closure

• Performance characteristic of propofol delivery system

  From start of anesthesia till 5- minutes post skin closure

• Performance characteristic of propofol delivery system

  From start of anesthesia till 5- minutes post skin closure

• . Propofol induction dose (mg/kg)

  From start of propofol injection till 10-minutes intraoperatively

Study Arms (2)

Conventional CLADS group

ACTIVE COMPARATOR

Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the conventional (prototype) closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of anesthesia

Drug: Propofol

Hermetic CLADS group

ACTIVE COMPARATOR

Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the hermetic closed-loop anaesthesia delivery system (CLADS).\[(Clarity Medical Private Ltd., Mohali, Punjab India\]. A BIS value of 50 will be used as the target point for induction and maintenance of anesthesia

Drug: Propofol

Interventions

Propofol DRUG

Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the conventional closed loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesia.

Conventional CLADS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-65 years-
• ASA physical status I-II
• undergoing elective non-cardiac surgery of minimum 60-minutes duration

You may not qualify if:

• Uncompensated cardiovascular disease (e.g., uncontrolled hypertension, atrio- ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction).
• Hepato-renal insufficiency.
• Any history of neurological disorder (e.g., epilepsy) or brain trauma
• Uncontrolled endocrine diseases (e.g., diabetes mellitus, hypothyroidism).
• Known allergy/hypersensitivity to the study drug.
• History of any psychiatric disorder and/or drug dependence/substance abuse.
• Requirement of postoperative ventilation.
• Refusal to informed consent.

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Nitin Sethi

New Delhi, National Capital Territory of Delhi, 110060, India

RECRUITING

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Nitin Sethi, DNB

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY DIRECTOR

• Amitabh Dutta, MD, PGDHR

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

• Goverdhan D Puri, MD, PhD

  Post Graduate Institute of Medical Education & Research, Chandigarh, India

  STUDY CHAIR

Central Study Contacts

Amitabh Dutta, MD, PGDHR

CONTACT

+919810848064; duttaamitabh@yahoo.co.in

Nitin Sethi, DNB

CONTACT

+919717494498; nitinsethi77@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Inside the operating, the attending anaesthesiologist will not be blinded to the technique utilized to administer general anaesthesia (GA) and the recovery parameters immediately after extubation. However, the postoperative patient recovery profile will be evaluated by an independent assessor blinded to the GA technique and peri-extubation profile.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Institute of Anaesthesiology, Pain & Perioperative Medicine

Model Details: One hundred and fifty participants (75/group) aged 18-65 years, ASA physical status I-II, of either sex, and undergoing elective non-cardiac surgery of minimum 60-minutes duration recruitment will be randomly divided into one of the two groups: Group-1 \[Conventional CLADS (CC) group, n= 75\]: Anaesthesia will be induced and maintained with propofol administered using the automated conventional CLADS. Group-2 \[Hermetic CLADS (HC) group, n= 75\]: Anaesthesia will be induced and maintained with propofol administered using the hermetic CLADS.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: December 9, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)