f Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea

Zagazig University30 enrolled

Overview

The investigator compared the sedative effects of propofol alone and ketamine added to propofol in drug induced sleep endoscopy

Propofol and ketamineare commonly used intravenous anesthetic drug used for procedural sedation. The investigator compared the effect of propofol and propofol ketamine in patients undergoing drug induced sleep endoscopy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Sleep Apnea Syndromes

Interventions

Ketamine + propofolDRUG

effect of adding ketamine to propofol for patients undergoing DISE surgery

propofolDRUG

effect of IV propofol alone for patients undergoing DISE surgery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Age \> 18 years old. * American society of anesthesiologists (ASA) physical status I or II. I / II Exclusion Criteria: * patient refusal * American society of anesthesiologists (ASA) physical status \> III * known or suspected allergy to the studied drugs or its components, allergy to eggs or soy beans * morbid obesity * patients with moderate to severe chronic obstructive pulmonary disease or uncontrolled asthma, congestive e heart failure ,seizures ,or cerebrovascular disease * pregnancy

Locations (1)

zagazig University

Zagazig, Sarkia, Egypt

RECRUITING

Outcomes

Primary Outcomes

Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction)

Time frame: the duration of the procedure under sedation is usually about 20 minutes to complete the procedure

Secondary Outcomes

time until suﬃcient sedation to start endoscopy

time to start endoscopy is deﬁned as the duration between start of the studied drugs until MOAA/S Modified observer assessment scale of alertness sedaion score 1 was obtained.

Time frame: It is about 5-10 minutes from start of studied drug till patient is ready to start endoscopy

The total propofol and ketamine dose(mg)/patient needed/patient was calculated

The total propofol and ketamine(mg) /patient dose needed/patient was calculated

Time frame: the procedure

any airway intervention and occurrence of laryngospasm after start of the DISE procedure until its completion with diagnosis of site and degree of obstruction

Once the DISE began, the airway interventions were important as outcomes, because these interrupted the clinical study of the DISE. Furthermore, laryngospasm was deﬁned by the requirement for positive pressure ventilation of \>20 cmH2O or administration of succinylcholine or propofol or any .

Time frame: the procedure

Adverse events (hypotension, bradycardia, arrhythmia, laryngospasm, cough, gag reﬂex, apnea or aspiration) were recorded during the procedure

Bradycardia was diagnosed if heart rate dropped below 60beats/min and atropine 0.01mg/kg was given if HR decreased below 50beats/min. Hypotension was diagnosed if mean arterial blood pressure (MAP) decreased by more than 30% from baseline or below 60mmHg

Central Contacts

Heba M EL-Asser, MD

CONTACT

01062393152 aseelaswad1@yahoo.com

Hala A Mohamed, MD

CONTACT

01000089532

Data from ClinicalTrials.gov

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