Effect of Dexmedetomidine on Propofol Requirement During Anesthesia

NCT02599168 | Completed Phase 4 DMC

• 1 other identifier: EC/04/15/807
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine, a selective alpha-2 agonist agent used for maintaining sedation in intensive care patients in receipt of mechanical ventilation, is being increasingly utilized in anaesthesia practice for facilitating anaesthesia depth as an adjunct to base anaesthetics (intravenous; propofol: inhalational; sevoflurane, desflurane). The investigators intend to assess the anaesthetic potential of dexmedetomidine in controlled anaesthesia settings empowered by the use of an objective, patient response based, safe, efficient, and patented closed loop anaesthesia delivery system (CLADS). CLADS functions on control of processed EEG response parameter captured from anaesthetized patients with the help of a BIS- monitor, which is continuously fed into a automated drug infusion pump. The infusion pump then accordingly delivers the anaesthetic drug to the patients based on pharmacodynamic requirements. If dexmedetomidine has anaesthesia potential then it is likely that propofol use delivered by CLADS can be reduced further. In addition the effect of two drugs (viz, base agent-propofol plus adjunct agent-dexmedetomidine) on different receptor site within the brain would help gain greater anaesthetic depth consistency as well as a lower incidence of intraoperative patient awareness. This prospective randomized two-arm study aims to assess effect of the use of dexmedetomidine on propofol requirements (primary objective), anaesthesia depth consistency, and intraoperative patient awareness (secondary objectives).

Conditions

Anesthesia

Keywords

dexmedetomidine; propofol; BIS; CLADS

Outcome Measures

Primary Outcomes (2)

• Change in Propofol usage in milligrams

  Comparison of 'dexmedetomidine' versus 'no dexmedetomidine' administration in decreasing quantitative propofol requirements (measured in milligrams) during closed loop anaesthesia delivery system empowered and Bi-spectral index controlled propofol-based general anaesthesia.

  From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively

• Assessment of change in anaesthesia depth using Bi-spectral index score

  Comparison of anaesthesia depth adequacy in intervention (with dexmedetomidine) versus control (without dexmedetomidine) using Varvel criteria to assess Bi-spectral index (BIS) score consistency during closed loop anaesthesia delivery system empowered and BIS-controlled propofol-based general anaesthesia

  From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively

Secondary Outcomes (6)

• Change in Intraoperative heart Rate (beats per minute)

  From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively

• Change in Intraoperative blood pressure - systolic , diastolic, and mean (mmHg)

  From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively

• Postoperative sedation

  From the end of anaesthesia till 24-hours, postoperatively

• Intraoperative awareness

  From the end of anaesthesia till 48-hours, postoperatively

• Postoperative nausea and vomiting

  From the end of anaesthesia till 24-hours, postoperatively

Study Arms (2)

Dexmedetomidine group

ACTIVE COMPARATOR

Patients will receive a pre-induction loading dose of dexmedetomidine 1-µ/kg over 10 minutes followed by an intraoperative infusion of 0.5-µ/kg/hour . Over and above the use of study drug dexmedetomidine propofol administration will be controlled with Closed Loop Anaesthesia Delivery system to maintain a consistent anaesthetic depth (BIS 40-60) using bispectral index monitor in all the patients

Drug: Propofol; Drug: Dexmedetomidine

Non-Dexmedetomidine group

PLACEBO COMPARATOR

Patients will receive a pre-induction loading dose of 0.9% saline solution over 10 minutes followed by an intraoperative infusion.Over and above the use of 0.9% saline solution propofol administration will be controlled with Closed Loop Anaesthesia Delivery system to maintain a consistent anaesthetic depth (BIS 40-60) using bispectral index monitor in all the patients

Drug: Propofol; Drug: Placebo (normal saline)

Interventions

Propofol DRUG

Dexmedetomidine group; Non-Dexmedetomidine group

Dexmedetomidine DRUG

Dexmedetomidine group

Placebo (normal saline) DRUG

Non-Dexmedetomidine group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I/II
• Undergoing elective laparoscopic / robotic surgery of more than 60-minutes duration

You may not qualify if:

• Cardiovascular disorders (uncontrolled hypertension, Atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance \& diastolic dysfunction)
• Neurological disorders (previous neurosurgery, psychiatric disorders, autonomic nervous system disorders- orthostatic hypotension, transient ischemic attacks)
• Any hepato-renal insufficiency
• Uncontrolled diabetes mellitus
• Known allergy/hypersensitivity to study drug
• Pulmonary dysfunction (restrictive /obstructive lung disease)
• Acute/chronic drug dependence/substance abuse

Sponsors & Collaborators

• Dr Nitin Sethi: lead

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Related Publications (1)

• Dutta A, Sethi N, Sood J, Panday BC, Gupta M, Choudhary P, Puri GD. The Effect of Dexmedetomidine on Propofol Requirements During Anesthesia Administered by Bispectral Index-Guided Closed-Loop Anesthesia Delivery System: A Randomized Controlled Study. Anesth Analg. 2019 Jul;129(1):84-91. doi: 10.1213/ANE.0000000000003470.

  PMID: 29787410 DERIVED

MeSH Terms

Interventions

Propofol; Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Goverdhan D Puri, MD, PhD

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

  STUDY DIRECTOR

• Jayashree Sood, MD, FFRCA

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY CHAIR

• Amitabh Dutta, MD

  Sir Ganga Ram Hospital, New Delhi, INDIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: November 6, 2015
• Study Start: December 5, 2015
• Primary Completion: March 20, 2017
• Study Completion: March 20, 2017
• Last Updated: October 4, 2017

Record last verified: 2017-10

Locations

IN (1)