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

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

Detailed Description
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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.

Official Title
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The Effect Of Adding Ketamine to Propofol For Drug-induced Sleep Endoscopy in Adult Patients With Obstructive Sleep Apnea A Randomized Controlled Study

Conditions
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Sleep Apnea Syndromes

Intervention / Treatment
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* Drug: Ketamine + propofol
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: propofol (P)<br>patients will receive only propofol intravenous for sedation | Drug: propofol<br>* effect of IV propofol alone for patients undergoing DISE surgery<br>* Other names: diprivan;|
| Active Comparator: propofol ketamine (pk)<br>patients will receive ketamine in addition to propofol intravenous for sedation | Drug: Ketamine + propofol<br>* effect of adding ketamine to propofol for patients undergoing DISE surgery<br>* Other names: ketamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction) | Number of patients with successful completion of the procedure (with diagnosis of site and degree of obstruction) | the duration of the procedure under sedation is usually about 20 minutes to complete the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 . | 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 | the procedure | 
| Time till Recovery | Time between stop of the study drugs until Modified observer's assessment of alertness sedation MOAA/S score of 4 was calculated and patient is shifted to recovery room( MOAA/S score btween 0-6 where 1 patient is ready for endoscopic airway evaluation and 1 patient is ready for discharge to recovery room ) Time till (MOAA/S) score 4 was calculated . | an average of 5 minutes between stop of drugs until Modified observer's assessment of alertness sedation MOAA/S became 4 | 
| patients and surgeon satisfaction | Both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied | about 30 minutes after complete recovery both patients' and surgeon satisfaction were recorded using a 7-point Likert-like verbal rating scales for patients and surgeon satisfaction where 7 is extremely satisfied and 1 is extremely dissatisfied | 
| Time to Aldrete's recovery scores became 10 (maximum) (patient is ready to discharge) was recored post procedure in the recovery room | Time to Aldrete's recovery scores became 10 (maximum)(patient is ready to discharge) was recorded post procedure in the recovery room | Average 15-30 minutes post procedure to have Aldrete's recovery scores 10 (maximum) (patient is ready to discharge) in the recovery room |