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Use of Dexmedetomidine for Deep Sedation in Patients Undergoing Outpatient Hysteroscopic Surgery

This study has been terminated.
(The study drug delayed time of discharge which is clinically impracticable.)
Sponsor:
Information provided by (Responsible Party):
Shireen Ahmad, Northwestern University
ClinicalTrials.gov Identifier:
NCT01337739
First received: April 19, 2010
Last updated: December 10, 2012
Last verified: December 2012
History of Changes
  Purpose

Patients undergoing deep sedation for outpatient procedures typically receive a combination of benzodiazepines, propofol, and opioids. Side effects of such anesthetics include respiratory depression, nausea and vomiting, and urinary retention, with resultant extended hospital stays and unanticipated admission. The use of dexmedetomidine for deep sedation may increase patient safety by maintaining respiratory drive, while providing sedation, hypnosis, and analgesia. Furthermore, patients may experience decreased pain, nausea, and time to discharge in the PACU, especially if dexmedetomidine decreases the requirement of other drugs such as opioids.

The hypothesis of this study is administration of dexmedetomidine during deep sedation for ambulatory hysteroscopic surgery will result in a 50% reduction of intraoperative opioid compared to sedation with propofol.


Condition Intervention
Pain
 Drug: Placebo administration
Drug: Dexmedetomidine administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Use of Dexmedetomidine for Deep Sedation in Patients Undergoing Outpatient Hysteroscopic Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Intraoperative opioid requirement [ Time Frame: intraoperative (day 1) ] [ Designated as safety issue: Yes ]
    Difference in intraoperative opioid (fentanyl) administration between patients receiving dexmedetomidine and those receiving propofol


Enrollment: 8
Study Start Date: October 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Comparator
Continuous infusion of placebo during operative procedure
 Drug: Placebo administration
Placebo administration
Active Comparator: Active Comparator
Administration of Dexmedetomidine
 Drug: Dexmedetomidine administration
Administration of Dexmedetomidine

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II
  • Age: 18-64 years
  • Female
  • Surgery: Gynecologic hysteroscopy
  • Language: English speaking
  • Consent: Obtained

Exclusion Criteria:

  • Pregnant or breast feeding
  • Significant arrhythmia or high degree atrioventricular nodal block
  • Significant hepatic or renal dysfunction
  • Chronic use or addiction to opiates or sedatives
  • History of heavy alcohol usage (>4 drinks/day)
  • Psychiatric or emotional disorder
  • Chronic use of α2-agonists
  • Patients with OSA or BMI greater than 30
  • Allergy to study drug or anesthetic medications utilized in the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337739

Locations
United States, Illinois
Prentice Womens Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Shireen Ahmad, MD Northwestern University
  More Information

Publications:

Responsible Party: Shireen Ahmad, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01337739     History of Changes
Other Study ID Numbers: STU00027663
Study First Received: April 19, 2010
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Hysteroscopic Surgery
Dexmedetomidine
Sedation
Opioids

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on May 16, 2013