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

Z

Zagazig University

Status and phase

Unknown
Phase 4

Conditions

Sleep Apnea Syndromes

Treatments

Drug: propofol
Drug: Ketamine + propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT04452383
Sedation in DISE

Details and patient eligibility

About

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

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

30 participants in 2 patient groups

propofol (P)
Active Comparator group
Description:
patients will receive only propofol intravenous for sedation
Treatment:
Drug: propofol
propofol ketamine (pk)
Active Comparator group
Description:
patients will receive ketamine in addition to propofol intravenous for sedation
Treatment:
Drug: Ketamine + propofol

Trial contacts and locations

1

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Central trial contact

Heba M EL-Asser, MD; Hala A Mohamed, MD

Data sourced from clinicaltrials.gov

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