MedTrace Logo

Effect of Dexmedetomidine on Propofol Requirement During Anesthesia

NCT02599168 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-10-04

No results posted yet for this study

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

Interventions

DRUG

Propofol

DRUG

Dexmedetomidine

DRUG

Placebo (normal saline)

Sponsors & Collaborators

  • Dr Nitin Sethi

    lead OTHER

Principal Investigators

  • Goverdhan D Puri, MD, PhD · Post Graduate Institute of Medical Education & Research, Chandigarh, India

  • Jayashree Sood, MD, FFRCA · Sir Ganga Ram Hospital, New Delhi, INDIA

  • Amitabh Dutta, MD · Sir Ganga Ram Hospital, New Delhi, INDIA

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-05
Primary Completion
2017-03-20
Completion
2017-03-20

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02599168 on ClinicalTrials.gov