Evaluation of Automated Propofol Delivery in Patients Undergoing Thoracic Surgery

NCT03307551 | Completed Phase 4 DMC

• 1 other identifier: EC/09/17/1254
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Automated delivery of propofol using computer-controlled closed loop anaesthesia device delivers propofol based on patient's frontal cortex electrical activity as determined by bi-spectral 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. By automatically controlling anaesthesia depth consistency they provide time to the anaesthesiologist to focus on other aspects of patient care such as managing intra-operative hemodynamics and ventilation perturbations during major surgeries. 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. Although a few studies have already evaluated these automated systems in patients undergoing thoracic surgery, but suffered from significant limitations (small number of patients, not dedicated to thoracic surgery cohort). Currently, there is no data available regarding CLADS performance vis a vis adequacy of GA and haemodynamic profile in patients undergoing thoracic surgery. We contend that propofol as delivered by CLADS will proffer greater consistency to anaesthesia depth, intra-operative hemodynamic stability, and rapid recovery upon anaesthesia discontinuation than manual means of delivering propofol TIVA. This randomised controlled study aims to compare the efficiency of CLADS-driven propofol TIVA versus manually controlled propofol TIVA in patients undergoing thoracic surgery.

Conditions

Thoracic Diseases; Surgery

Keywords

propofol, automated, manual

Outcome Measures

Primary Outcomes (1)

• Anaesthesia depth consistency using BIS scores

  Determined by the percentage of the total anaesthesia time in which the BIS scores remain within a score of 10% of the target BIS (i.e. BIS-50) in both the study arms.

  From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively

Secondary Outcomes (8)

• Performance Characteristic of propofol anaesthesia delivery system

  From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively

• Change in Intra-operative heart Rate (beats per minute)

  From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively

• Change in Intra-operative systolic , diastolic, and mean (mmHg)

  From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively

• Recovery from anesthesia

  From end of anaesthesia till 20-minutes postoperatively]

• Recovery from anesthesia

  From end of anaesthesia till 20-minutes postoperatively]

Study Arms (2)

CLADS group

ACTIVE COMPARATOR

Anaesthesia will be induced and maintained with Propofol administered by CLADS. Its administration rate will be controlled by a feedback loop facilitated by BIS monitoring. A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesia.

Drug: Propofol

Manual group

ACTIVE COMPARATOR

Anaesthesia will be induced and maintained with propofol administration by an intravenous infusion pump. Its administration rate will be controlled manually to maintain a target BIS of 50 during induction and maintenance of anaesthesia.

Drug: Propofol

Interventions

Propofol DRUG

Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient (CLADS group)

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:

• ASA physical status I-III

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

• Dr Nitin Sethi: lead

Study Sites (1)

Sir Ganga Ram Hospital

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

Location

MeSH Terms

Conditions

Thoracic Diseases

Interventions

Propofol

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Goverdhan D Puri, MD, PhD

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

  STUDY CHAIR

• Jayashree Sood, MD,FFRCA

  Sir Ganga Ram Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be blinded to the type of anaesthesia intervention.The attending anaesthesiologist will however not be blinded to the technique utilized to administer GA and recovery immediately after extubation inside the OR. The postoperative patient recovery profile will be evaluated by an independent assessor blinded to the technique of GA.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor & Consultant

Model Details: 30-patients aged 18-65 years, ASA physical status I-III, of either sex, and undergoing unilateral open thoracic surgery or unilateral video-assisted thoracic surgery (VATS) will randomly allocated by computer generated numbers to one of the following two groups of 15 patients each: Group-1 \[CLADS Group, n=15, Study group\]: Anaesthesia will be induced and maintained with propofol administered using the automated CLADS. Group-2 \[Manual Group, n=15, Control group\]: Anaesthesia will be induced and maintained with propofol administered using manually controlled infusion pumps titrated to BIS scores.

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 11, 2017
• Study Start: October 31, 2017
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)