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Effect of Dexmedetomidine on Propofol Requirement During Anesthesia

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ClinicalTrials.gov Identifier: NCT02599168
Recruitment Status : Completed
First Posted : November 6, 2015
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Nitin Sethi, Sir Ganga Ram Hospital

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).

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Propofol Drug: Dexmedetomidine Drug: Placebo (normal saline) Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Dexmedetomidine on Propofol Requirements During Anesthesia Administered by Bispectral Index-Guided Closed-Loop Anesthesia Delivery System: A Randomized Controlled Study
Actual Study Start Date : December 5, 2015
Actual Primary Completion Date : March 20, 2017
Actual Study Completion Date : March 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexmedetomidine group
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
Placebo Comparator: Non-Dexmedetomidine group
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)



Primary Outcome Measures :
  1. Change in Propofol usage in milligrams [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively ]
    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.

  2. Assessment of change in anaesthesia depth using Bi-spectral index score [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively ]
    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


Secondary Outcome Measures :
  1. Change in Intraoperative heart Rate (beats per minute) [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively ]
    Comparison of intraoperative heart rate in the 'intervention' (with dexmedetomidine) versus 'control' (without dexmedetomidine) during closed loop anaesthesia delivery system empowered and Bi-spectral index controlled propofol-based GA

  2. Change in Intraoperative blood pressure - systolic , diastolic, and mean (mmHg) [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively ]
    Comparison of intraoperative blood pressure (systolic , diastolic, and mean) in the 'intervention' (with dexmedetomidine) versus 'control' (without dexmedetomidine) during closed loop anaesthesia delivery system empowered and Bi-spectral index controlled propofol-based GA

  3. Postoperative sedation [ Time Frame: From the end of anaesthesia till 24-hours, postoperatively ]
    Will be assessed using Observer asssesment of Alertness/Sedation Scale (OAAS)

  4. Intraoperative awareness [ Time Frame: From the end of anaesthesia till 48-hours, postoperatively ]
    Will be assessed using modified brice questionnaire

  5. Postoperative nausea and vomiting [ Time Frame: From the end of anaesthesia till 24-hours, postoperatively ]
    Will be assessed using PONV scale

  6. Postoperative Analgeisa [ Time Frame: From the end of anaesthesia till 24-hours, postoperatively ]
    Will be assessed using Visual Analogue Scale (VAS) Score



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02599168


Locations
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India
Sir Ganga Ram Hospital
New Delhi, India, 110060
Sponsors and Collaborators
Dr Nitin Sethi
Investigators
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Study Director: Goverdhan D Puri, MD, PhD Post Graduate Institute of Medical Education & Research, Chandigarh, India
Study Chair: Jayashree Sood, MD, FFRCA Sir Ganga Ram Hospital, New Delhi, INDIA
Principal Investigator: Amitabh Dutta, MD Sir Ganga Ram Hospital, New Delhi, INDIA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Nitin Sethi, Doctor, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT02599168    
Other Study ID Numbers: EC/04/15/807
First Posted: November 6, 2015    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017
Keywords provided by Dr Nitin Sethi, Sir Ganga Ram Hospital:
dexmedetomidine
propofol
BIS
CLADS
Additional relevant MeSH terms:
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Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action