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Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea

Primary Purpose

Sleep Apnea, Obstructive Sleep Apnea, Postoperative Complications

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Control
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sleep Apnea focused on measuring Ketamine, Postoperative morbidity

Eligibility Criteria

19 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 19-100
  • scheduled to undergo general ENT or Orthopedic Surgery
  • diagnosis of obstructive sleep apnea as confirmed by sleep study or deemed high risked for obstructive sleep apnea by clinical predictors (greater than 4 clinical predictors of obstructive sleep apnea as described by STOP BANG ).

Exclusion Criteria:

  • positive pregnancy test
  • ASA > III
  • history of alcohol or narcotic abuse in last 90 days
  • significant cardiovascular or respiratory disease (baseline oxygen saturation below 92%)
  • significant psychiatric or neurologic disease
  • history of significant hepatic or renal disease (baseline creatinine>1.5)
  • history of allergy or contraindication to anesthetic agents or ketamine including patients with increased ICP
  • increased IOP
  • severe arrhythmias
  • history of delirium
  • history of hallucinations
  • history of psychosis
  • history of uncontrolled seizures
  • potential risk for malignant hyperthermia (family history)
  • history of difficult intubation that would preclude standard induction of anesthesia
  • prisoners
  • persons who are mentally impaired
  • non-English speakers

Sites / Locations

  • UAB Department of Anesthesiology and Perioperative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control Group

Ketamine Group

Arm Description

OSA patients will receive standard inhaled anesthesia with normal saline infusion

OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.

Outcomes

Primary Outcome Measures

Pain Scores
Visual Analog Scale pain rating

Secondary Outcome Measures

Patient Satisfaction Score
Patients will rate their quality of anesthesia services

Full Information

First Posted
April 6, 2017
Last Updated
December 18, 2019
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03109418
Brief Title
Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea
Official Title
Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea: A Prospective, Randomized, Controlled, Double-Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Recruitment challenges
Study Start Date
June 2, 2016 (Actual)
Primary Completion Date
September 12, 2018 (Actual)
Study Completion Date
September 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.
Detailed Description
Obstructive sleep apnea (OSA) affects millions of people in the U.S., and currently, there is not a well-established, general anesthetic technique that clearly decreases the risk of postoperative respiratory complications in these patients. If OSA patients have significantly decreased postoperative opioid requirements and improved recovery profiles in the PACU, the protocol could have significant implications in defining future standardized general anesthesia recommendations for patients with this disease. Ultimately, the aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea. The objective of this study is to compare the postoperative recovery profile of OSA patients receiving standard Sevoflurane inhaled anesthesia with normal saline infusion versus Sevoflurane combined with a low-dose ketamine infusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive Sleep Apnea, Postoperative Complications
Keywords
Ketamine, Postoperative morbidity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
OSA patients will receive standard inhaled anesthesia with normal saline infusion
Arm Title
Ketamine Group
Arm Type
Active Comparator
Arm Description
OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
OSA patients receiving standard inhaled anesthesia combined with normal saline
Primary Outcome Measure Information:
Title
Pain Scores
Description
Visual Analog Scale pain rating
Time Frame
up to 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Patient Satisfaction Score
Description
Patients will rate their quality of anesthesia services
Time Frame
At 24 hrs post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 19-100 scheduled to undergo general ENT or Orthopedic Surgery diagnosis of obstructive sleep apnea as confirmed by sleep study or deemed high risked for obstructive sleep apnea by clinical predictors (greater than 4 clinical predictors of obstructive sleep apnea as described by STOP BANG ). Exclusion Criteria: positive pregnancy test ASA > III history of alcohol or narcotic abuse in last 90 days significant cardiovascular or respiratory disease (baseline oxygen saturation below 92%) significant psychiatric or neurologic disease history of significant hepatic or renal disease (baseline creatinine>1.5) history of allergy or contraindication to anesthetic agents or ketamine including patients with increased ICP increased IOP severe arrhythmias history of delirium history of hallucinations history of psychosis history of uncontrolled seizures potential risk for malignant hyperthermia (family history) history of difficult intubation that would preclude standard induction of anesthesia prisoners persons who are mentally impaired non-English speakers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Nagi, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Department of Anesthesiology and Perioperative Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea

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