NCT03109418

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 19 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep Apnea
• Obstructive Sleep Apnea
• Postoperative Complications

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-06-02
• Primary completion: 2018-09-12
• Completion: 2018-09-12
• First posted: 2017-04-12
• Last updated: 2019-12-19
• Results posted: 2019-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study