Comparison of TIVA by Closed Loop Anaesthesia Delivery System Versus Target Controlled Infusion Device

NCT04731480 | Completed DMC

• 1 other identifier: EC/12/20/1787
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief Summary

Total intravenous anaesthesia (TIVA) is now being adopted as a preferred technique for providing GA because of its various inherent advantages like reduced PONV incidence, improved quality of recovery post GA, anti-inflammatory and anti-oxidant action, anti-neoplastic activity, analgesic action, and absence of greenhouse effect. Over the years propofol-TIVA delivery has become more methodical due to the use of target-controlled infusion (TCI) systems. The current TCI technology has evolved with the introduction of the 'open' TCI concept wherein syringes of any configuration can be attached to the TCI-pumps having pre-programmed propofol PK-PD models. The two most commonly use propofol PK-PD models are the Marsh and Schneider models targeting the propofol blood plasma concentration and effect site concentration in the brain respectively. Automated delivery of propofol using computer-controlled closed loop anaesthesia device delivers 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. A recent advance in propofol delivery has been the development of automated closed loop anaesthesia delivery system. These devices deliver propofol based on patient's frontal cortex electrical activity as determined by bispectral index (BIS).Closed loop anaesthesia delivery system (CLADS) is an indigenously developed continuous automated intravenous infusion system which delivers propofol based on patients' EEG profile (BIS) feedback. Currently there is no data available comparing the efficacy of TCI delivered propofol versus automated propofol delivery systems. The investigators hypothesize that automated propofol delivery by CLADS will provide more consistent anaesthesia depth maintenance as compared to TCI delivered propofol. This randomized controlled study aims to compare the efficiency of CLADS-driven propofol TIVA versus TCI administered in patients undergoing non-cardiac surgery with respect to adequacy of anaesthesia depth maintenance, performance characteristic of propofol delivery system hemodynamic stability, recovery from anaesthesia and postoperative sedation.

Conditions

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 end of surgery till 8 hours intraoperatively

Secondary Outcomes (12)

• Performance characteristic of propofol delivery system

  From end of surgery till 10-hours intraoperatively

• Performance characteristic of propofol delivery system

  From end of surgery till 10-hours intraoperatively

• Performance characteristic of propofol delivery system

  From end of surgery till 10-hours intraoperatively

• Performance characteristic of propofol delivery system

  From end of surgery till 10-hours intraoperatively

• Propofol induction dose (mg/kg)

  From start of propofol injection till 2-minutes intraoperatively

Study Arms (4)

CLADS group

ACTIVE COMPARATOR

Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the 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

Marsh model group

ACTIVE COMPARATOR

The target-controlled infusion (TCI) pump will be programmed to marsh model with the target plasma site concentration of 3-µg/ml. The plasma concentration will be altered to maintain a target BIS of 50 during induction and maintenance of anesthesia

Drug: Propofol

Schnider model group

ACTIVE COMPARATOR

The TCI-pump will be programmed to will be programmed to Schnider model with the target effect site concentration of 3-µg/ml. The effect-site concentration will be altered to maintain a target BIS of 50 during induction and maintenance of anesthesia.

Drug: Propofol

Manual group

ACTIVE COMPARATOR

Propofol administration will be controlled manually using an intravenous infusion pump to maintain a target BIS of 50 during 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 closed loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesia.

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
• 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

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (2)

Nitin Sethi

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

Location

Sir Ganga Ram Hospital

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

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jayashree Sood, MBBS, MD, FFRCA, PGDHHM, FICA

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY CHAIR

• Goverdhan D Puri, MBBS, MD, PhD

  Postgraduate Institute for Medical Education & Research, Chandigarh, India

  STUDY DIRECTOR

• Nitin Sethi, MBBS, DNB

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

• Amitabh Dutta, MBBS, MD, PGDHR

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

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

Model Details: One hundred sixty-participants (40/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 four groups: Group-1 \[CLADS group, n= 40, study group\], Group-2 \[Marsh model (MM) group, n= 40, study group\], Group-3 \[Schneider Model (SM) Group, n= 40, study group\], and Group-4 \[Manual (M) Group, n= 40, Control group\].

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 1, 2021
• Study Start: February 2, 2021
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)