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

Stopped early · Not applicable · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT01337739

Run by

Northwestern University

People needed

8

Starts

2010-10-01

Expected to finish

2012-04-01

Last updated by the study team

2013-07-12

Who can join

Age: 18 and older, up to 64. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Prentice Womens Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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