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

NCT03109418 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: F160224001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Apnea; Obstructive Sleep Apnea; Postoperative Complications

Keywords

Ketamine; Postoperative morbidity

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Visual Analog Scale pain rating

  up to 24 hours postoperatively

Secondary Outcomes (1)

• Patient Satisfaction Score

  At 24 hrs post-op

Study Arms (2)

Control Group

PLACEBO COMPARATOR

OSA patients will receive standard inhaled anesthesia with normal saline infusion

Procedure: Control

Ketamine Group

ACTIVE COMPARATOR

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

Drug: Ketamine

Interventions

Ketamine DRUG

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

Also known as: Ketalar

Ketamine Group

Control PROCEDURE

OSA patients receiving standard inhaled anesthesia combined with normal saline

Control Group

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Postoperative Complications

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Adam Sturdivant
• Organization: University of Alabama at Birmingham

Adamsturdivant@uabmc.edu

205-934-4042

Study Officials

• Peter A Nagi, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: June 2, 2016
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: December 19, 2019
• Results First Posted: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)