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

May 23, 2013 updated by: Shireen Ahmad, Northwestern University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients will be recruited up to 21 days prior to the day of surgery. Preoperatively: A full preoperative assessment will be completed. Preoperatively, patients will be instructed on the proper use of the verbal rating scale (VRS) for pain and nausea scores. Patients will be randomized by a computer-generated scheme to receive prepared infusions containing either dexmedetomidine (4grams per milliliter or propofol (10 milligrams per milliliter) intraoperatively. The study drug infusions will be prepared by study personnel who are not involved in the assessments. Patients, medical personnel other than the anesthesiologist, and outcome assessors will be blinded to treatment allocation. Only the anesthesiologist administering the treatment infusion and medications intraoperatively will be aware of group allocation.

Intraoperatively: A standardized intraoperative anesthetic plan will be utilized by the anesthesia personnel.All patients will receive premedication with midazolam 2 milligrams intravenous bolus and ketorolac 30 milligrams via the intravenous catheter.

Intraoperative monitoring will include standard monitoring which includes noninvasive blood pressure, electrocardiography, pulse oximetry, and capnography. In addition transcutaneous CO2 will be monitored using the Tosca monitor.(Radiometer, Basel, Austria).

The study drug infusion will be started as either dexmedetomidine (1gram per kilogram over 10 min as a loading dose, followed by a maintenance infusion 0.2 to 1.5 grams per kilogram or propofol (started at 75gram per kilogram per minute and ranging from 12.5 to 125 gram per kilogram per minute titrated to maintain the Observer's Assessment of Alertness/Sedation Scale (OAA/SS) between 0-1. Intraoperative fluids will be restricted to 500 milliliter + 100mililiterml of Lactated Ringer's solution. At the onset of the procedure, the anesthesiologist will administer 0.7gram/kilogram bolus of fentanyl intravenous, followed by additional 25-50gram boluses for any patient movement to surgical stimulus. All patients will receive ondansetron 4 milligram IV 15-20 minutes prior to the end of surgery. Patients will receive glycopyrrolate 0.2 mg IV if HR decreases below 50 bpm.

Postoperatively:

In the recovery room, VRS for pain will be assessed upon admission and at 30 minute intervals thereafter. Analgesics will be administered according to the severity of the pain and degree of alertness.Vomiting and retching episodes.will be assessed at 30 minute intervals using a VRS, and patients with scores greater than 4 or those who request antiemetic treatment will be treated with metoclopramide 10 mg IV.

Recovery from anesthesia and return of psychomotor ability will be assessed using the Modified Post Anesthesia Discharge Scoring System (MPADSS). A score of 8 or greater will indicate discharge readiness. Discharge readiness requires that a patient be awake and alert with stable vital signs, able to ambulate without assistance, and free of side effects. 24 hours after discharge.

Times from end of surgery to oral intake and readiness for discharge, , and all adverse events and medications administered will be recorded. These data will be recorded by research staff blinded to the study group assignments. Subjects will be contacted by telephone 24 hours after surgery to obtain post-discharge data, including a repeat QoR-40 assessment.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60611
        • Prentice Womens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Comparator
Continuous infusion of placebo during operative procedure
Drug: Placebo Comparator
Placebo administration (.9 normal saline sterile)
Active Comparator: Active Comparator
Administration of Dexmedetomidine
Drug: Active Comparator
Administration of Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Primary Outcome Will be the Difference in Intraoperative Opioid (Fentanyl) Administration Between Patients Receiving Dexmedetomidine and Those Receiving Propofol.
Time Frame: Interoperative period
The primary outcome will be the difference in intraoperative opioid (fentanyl) administration between patients receiving dexmedetomidine and those receiving propofol. As described by mean and standard deviation.
Interoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Discharge
Time Frame: 24 Hours
Time to discharge from the Post Anesthesia Care Unit or home or to hospital room.
24 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Shireen Ahmad, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

April 19, 2010

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

July 12, 2013

Last Update Submitted That Met QC Criteria

May 23, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU00027663

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Placebo Comparator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe