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

NCT ID: NCT04452383

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-23

Study Completion Date

2021-12-30

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.

Conditions

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Sleep Apnea Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
A computer-generated randomization table divided patients into 2 equal groups randomly allocated patients.

Study Groups

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propofol (P)

patients will receive only propofol intravenous for sedation

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

effect of IV propofol alone for patients undergoing DISE surgery

propofol ketamine (pk)

patients will receive ketamine in addition to propofol intravenous for sedation

Group Type ACTIVE_COMPARATOR

Ketamine + propofol

Intervention Type DRUG

effect of adding ketamine to propofol for patients undergoing DISE surgery

Interventions

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Ketamine + propofol

effect of adding ketamine to propofol for patients undergoing DISE surgery

Intervention Type DRUG

propofol

effect of IV propofol alone for patients undergoing DISE surgery

Intervention Type DRUG

Other Intervention Names

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ketamine diprivan

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Heba Mohamed EL -Asser,MD

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heba M EL-Asser, MD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

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zagazig University

Zagazig, Sarkia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Heba M EL-Asser, MD

Role: CONTACT

Phone: 01062393152

Email: [email protected]

Hala A Mohamed, MD

Role: CONTACT

Phone: 01000089532

Facility Contacts

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Heba M ELasser, MD

Role: primary

References

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Cho JS, Soh S, Kim EJ, Cho HJ, Shin S, Kim HJ, Koo BN. Comparison of three sedation regimens for drug-induced sleep endoscopy. Sleep Breath. 2015 May;19(2):711-7. doi: 10.1007/s11325-015-1127-9. Epub 2015 Feb 3.

Reference Type BACKGROUND
PMID: 25643766 (View on PubMed)

De Vito A, Agnoletti V, Berrettini S, Piraccini E, Criscuolo A, Corso R, Campanini A, Gambale G, Vicini C. Drug-induced sleep endoscopy: conventional versus target controlled infusion techniques--a randomized controlled study. Eur Arch Otorhinolaryngol. 2011 Mar;268(3):457-62. doi: 10.1007/s00405-010-1376-y. Epub 2010 Sep 2.

Reference Type BACKGROUND
PMID: 20811901 (View on PubMed)

Other Identifiers

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Sedation in DISE

Identifier Type: -

Identifier Source: org_study_id