Dex as Analgesic Adjuvant in OSA Patients

August 1, 2018 updated by: Montefiore Medical Center

A Double Blinded Randomized Placebo Controlled Study Evaluating the Use of Intraoperative Dexmedetomidine in Reducing Postoperative Pain and Narcotic Requirement in Patients With Moderate to Severe OSA.

The purpose of this study is to assess whether intravenous peri-operative Dexmedetomidine reduces opioid requirements and or improves pain control after Uvulopalatopharyngoplasty (UPPP) in patients with obstructive sleep apnea (OSA).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND/STUDY SIGNIFICANCE

Patients with OSA undergoing surgery have increased surgical risk compared to patients that do not have OSA . Perioperative medication such as benzodiazepines and opioids can decrease upper airway tone, inhibit central respiratory drive and inhibit upper airway reflexes. The supine position may also worsen the severity of the OSA. Additionally, this group of patients is more likely to have a higher incidence of complications, particularly post operative hypoxemia , difficult intubation , and complicated extubation course .

Uvulopalatopharyngoplasty (UPPP) along with other tongue base procedures are commonly performed surgical procedures used to help alleviate the symptoms of obstructive sleep apnea (OSA). Postoperative management of oropharyngeal pain is challenging since narcotic administration may compromise respiratory status in OSA patients. The Anesthesiology and Otorhinolaryngology communities have begun to rethink acceptable narcotic use in OSA patients especially following the recent FDA announcement highlighting serious adverse effects related to codeine consumption in children who had undergone tonsillectomies.

Dexmedetomidine (Precedex) is a sedative with minimal respiratory depression. Its mechanism is via alpha 2 agonism and has 8 times the affinity for the alpha 2 adrenoreceptor than clonidine. It has been shown to have sedative, analgesic, and anxiolytic effects. It produces a predictable and dose dependent decrease in heart rate and blood pressure. Dexmedetomidine undergoes extensive metabolism in the liver and is then eliminated as methyl and glucuronide conjugates mostly via the renal system. The pharmacokinetics are markedly affected by hepatic insufficiency .

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

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
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or older
  • Patients scheduled for UPPP
  • Patients with diagnosis of OSA via polysomnography
  • American Society of Anesthesiology (ASA) classification 3 or lower

Exclusion Criteria:

  • Bradycardia as defined as resting heart rate <60 Beats per min (BPM) or symptomatic
  • Any degree of heart block diagnosed by ECG
  • Hypotension as defined as <20% from baseline or symptomatic
  • Liver failure, (two fold rise in liver enzymes)
  • Chronic Kidney Disease (CKD) III or greater
  • History of allergy to opioids or dexmedetomidine
  • ASA classification 4 or higher
  • ICU or Step down admission
  • Difficult airway as defined by previous history of difficult intubation or requiring a fiberoptic intubation.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine Sedation
This group will receive 1mcg/kg bolus of dexmedetomidine over 15 minutes after intubation followed by an infusion of dexmedetomidine at 0.5mcg/kg/hr until approximately 30 minutes before the end of surgery.
Drug: Dexmedetomidine
Dexmedetomidine is an alpha-2 agonist that provides both sedation and analgesia
Other Names:
  • Precedex
Placebo Comparator: Placebo
This group will receive a colorless, odorless liquid (i.e. normal saline) in order to resemble Dexmedetomidine.
Drug: Placebo
saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: within 24 hours post-operative
Patient self-reported pain scores will be measured immediately after awakening post-op using the Numerical Pain Rating Scale and opioid requirements using morphine equivalents
within 24 hours post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: within 24 hours post-operative
Pain score and opioid requirements will continue to be measured up to 24 hours postoperatively
within 24 hours post-operative
Nausea
Time Frame: within 24 hours post-operative
participants experience of nausea will be reported
within 24 hours post-operative
Hypoxia
Time Frame: within 24 hours post-operative
Number of hypoxic events will be calculated
within 24 hours post-operative
Length of hospital stay
Time Frame: from admission to discharge, up to 14 days
Number of days spent in the hospital from admission to discharge will be assessed.
from admission to discharge, up to 14 days
Sedation
Time Frame: within 24 hours post-operative
Ramsay Sedation Scale
within 24 hours post-operative
Time to extubation
Time Frame: from post-operative until extubation, up to 72 hours
length of time from operation to removal of endotracheal tube will be measured
from post-operative until extubation, up to 72 hours
Number of participants experiencing vomiting
Time Frame: within 24 hours post-operative
participants' experiencing vomiting will be assessed and reported by care providers
within 24 hours post-operative

Collaborators and Investigators

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

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Tracey Straker, MD, Montefiore Medical Center

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

July 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 3, 2018

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-10-168

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

product manufactured in and exported from the U.S.

Yes

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.

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