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

Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea: A Prospective, Randomized, Controlled, Double-Blind Study

The aim of this study is to substantially reduce overall postoperative morbidity and mortality associated with obstructive sleep apnea.

Study Overview

• Status: Terminated
• Conditions: Postoperative Complications; Obstructive Sleep Apnea; Sleep Apnea
• Intervention / Treatment: Procedure: Control; Drug: Ketamine

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • UAB Department of Anesthesiology and Perioperative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; OSA patients will receive standard inhaled anesthesia with normal saline infusion	Procedure: Control; OSA patients receiving standard inhaled anesthesia combined with normal saline
Active Comparator: Ketamine Group; OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.	Drug: Ketamine; 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; Other Names: Ketalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Visual Analog Scale pain rating	up to 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Score	Patients will rate their quality of anesthesia services	At 24 hrs post-op

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Peter A Nagi, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2016
• Primary Completion (Actual): September 12, 2018
• Study Completion (Actual): September 12, 2018

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Ketamine; Postoperative morbidity
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Postoperative Complications; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: F160224001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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