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

• ClinicalTrials.gov Identifier: NCT03109418
• Recruitment Status: Terminated
• First Posted: April 12, 2017
• Results First Posted: December 19, 2019
• Last Update Posted: December 19, 2019
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Peter A. Nagi, University of Alabama at Birmingham

Tracking Information

• First Submitted Date: April 6, 2017
• First Posted Date: April 12, 2017
• Results First Submitted Date: October 1, 2019
• Results First Posted Date: December 19, 2019
• Last Update Posted Date: December 19, 2019
• Actual Study Start Date: June 2, 2016
• Actual Primary Completion Date: September 12, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 18, 2019)

Pain Scores [ Time Frame: up to 24 hours postoperatively ]

Visual Analog Scale pain rating

• Original Primary Outcome Measures (submitted: April 6, 2017): Time to first analgesic [ Time Frame: Baseline to 48 hrs postoperatively ]

Current Secondary Outcome Measures (submitted: December 18, 2019)

Patient Satisfaction Score [ Time Frame: At 24 hrs post-op ]

Patients will rate their quality of anesthesia services

Original Secondary Outcome Measures (submitted: April 6, 2017)

• Comparison of Patient Demographics [ Time Frame: Baseline to 48 hrs postoperatively ]
  Vital signs
• Mean number of analgesic (PCA) demands [ Time Frame: Baseline to 48 hrs postoperatively ]
  Total number of PCA demands during the initial 24 hour postoperative period
• Mean amount of analgesic consumed in the OR and PACU [ Time Frame: Baseline to 48 hrs postoperatively ]
  Total amount of morphine administered by PCA during the initial 24 hour postoperative period
• Frequency of side events [ Time Frame: Baseline to 48 hrs postoperatively ]
  Side events includes adverse respiratory event, hemodynamic instability, presence of nausea, presence of vomiting, presence dysphoria, and admission to the ICU
• Mean number of desaturations [ Time Frame: Baseline to 48 hrs postoperatively ]
  The oxygen desaturation index (ODI) or the number of desaturations per hour of recording will be collected. ODI correlates with PSG-determined apnea/hypopnea idex and can be used as an indicator of postoperative apneic episodes.
• Patient Satisfaction Score [ Time Frame: At 24 hrs post-op ]
  Patients will rate their quality of anesthesia services

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea
• Official Title: Intraoperative Low-dose Ketamine Infusion for Patients With Obstructive Sleep Apnea: A Prospective, Randomized, Controlled, Double-Blind Study
• 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.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention

Condition

• Sleep Apnea
• Obstructive Sleep Apnea
• Postoperative Complications

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

Study Arms

• Placebo Comparator: Control Group
  OSA patients will receive standard inhaled anesthesia with normal saline infusion
  Intervention: Procedure: Control
• Active Comparator: Ketamine Group
  OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion.
  Intervention: Drug: Ketamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 14, 2018): 9
• Original Estimated Enrollment (submitted: April 6, 2017): 150
• Actual Study Completion Date: September 12, 2018
• Actual Primary Completion Date: September 12, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 100 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03109418
• Other Study ID Numbers: F160224001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Peter A. Nagi, University of Alabama at Birmingham
• Study Sponsor: University of Alabama at Birmingham
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Alabama at Birmingham
• Verification Date: December 2019