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

NCT ID: NCT03109418

Last Updated: 2019-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-02

Study Completion Date

2018-09-12

Brief Summary

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

Detailed Description

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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

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Sleep Apnea Obstructive Sleep Apnea Postoperative Complications

Keywords

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Ketamine Postoperative morbidity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control Group

OSA patients will receive standard inhaled anesthesia with normal saline infusion

Group Type PLACEBO_COMPARATOR

Control

Intervention Type PROCEDURE

OSA patients receiving standard inhaled anesthesia combined with normal saline

Ketamine Group

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Control

OSA patients receiving standard inhaled anesthesia combined with normal saline

Intervention Type PROCEDURE

Other Intervention Names

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Ketalar

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Peter A. Nagi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter A Nagi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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F160224001

Identifier Type: -

Identifier Source: org_study_id