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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03109418
• Other study ID #: F160224001
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 2, 2016
• Est. completion date: September 12, 2018

Study information

• Verified date: December 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: September 12, 2018
• Est. primary completion date: September 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Postoperative Complications
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Procedure:
• Control
OSA patients receiving standard inhaled anesthesia combined with normal saline

Locations

Country	Name	City	State
United States	UAB Department of Anesthesiology and Perioperative Medicine	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores	Visual Analog Scale pain rating	up to 24 hours postoperatively
Secondary	Patient Satisfaction Score	Patients will rate their quality of anesthesia services	At 24 hrs post-op