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

Phase 2

Terminated

• Conditions: Sleep Apnea; Obstructive Sleep Apnea; Postoperative Complications
• Interventions: Procedure: Control; Drug: Ketamine

• Registration Number: NCT03109418
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06-02
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Primary Completion: 2018-09-12
• Study Completion: 2018-09-12
• Results First Submitted: 2019-10-01
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-18
• Last Update Submitted: 2019-12-18
• Results First Posted: 2019-12-19
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 ).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control	OSA patients will receive standard inhaled anesthesia with normal saline infusion
Ketamine Group	Ketamine	OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.

Primary Outcome Measures

Name	Time	Method
Pain Scores	up to 24 hours postoperatively	Visual Analog Scale pain rating

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Score	At 24 hrs post-op	Patients will rate their quality of anesthesia services

Trial Locations

Locations (1)

UAB Department of Anesthesiology and Perioperative Medicine; 🇺🇸 Birmingham, Alabama, United States