Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients

NCT ID: NCT02863861

Last Updated: 2016-12-22

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Brief Summary

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The purpose of this study is to compere between Propofol-Ketamine combination and Dexmedetomidine-Ketamine combination for sedation in upper gastrointestinal endoscopy in paediatric patients.

Detailed Description

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Conditions

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Upper Gastrointestinal Endoscopy

Keywords

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Sedation Pediatric Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group PK

Propofol-Ketamine group: patients in this group will receive IV ketamine at a dose of 1mg.kg-1 in addition to IV propofol 1mg.kg-1 for induction with added doses of propofol 1mg.kg-1 when needed.

Group Type EXPERIMENTAL

propofol-ketamine

Intervention Type DRUG

Group DK

Dexmedetomidine-Ketamine group: patients in this group will receive IV ketamine at a dose of 1mg.kg-1 in addition to IV dexmedetomidine 0.5 mcg.kg-1 for induction with additional doses of dexmedetomidine 0.5mcg.kg-1 when required

Group Type EXPERIMENTAL

Dexmedetomidine-ketamine

Intervention Type DRUG

Interventions

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Dexmedetomidine-ketamine

Intervention Type DRUG

propofol-ketamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists ASA I-II patients aging 2-7 years.

Exclusion Criteria

known allergy to any of the study drugs, significant cardiovascular disease vomiting.
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Akram Mohamed Mohamed Amer

Lecturer in Department of Anesthesiology, Intensive Care, and Pain Management, Faculty of Medicine, Ain-Shams University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain shams university- faculty of medicine- department of anesthesia, intensive care and pain management

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Amer AM, Youssef AM, El-Ozairy HS, El-Hennawy AM. [Propofol-ketamine versus dexmedetomidine-ketamine for sedation during upper gastrointestinal endoscopy in pediatric patients: a randomized clinical trial]. Braz J Anesthesiol. 2020 Nov-Dec;70(6):620-626. doi: 10.1016/j.bjan.2020.08.005. Epub 2020 Dec 5.

Reference Type DERIVED
PMID: 33293038 (View on PubMed)

Other Identifiers

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FMASU R 12/2016

Identifier Type: -

Identifier Source: org_study_id