Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients

December 21, 2016 updated by: Akram Mohamed Mohamed Amer, Ain Shams University

Comparative Study Between Propofol-Ketamine Combination and Dexmedetomidine-Ketamine Combination for Sedation in Upper Gastrointestinal Endoscopy in Paediatric Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: propofol-ketamine
Experimental: 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
Drug: Dexmedetomidine-ketamine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of stay in PACU
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 8, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Estimate)

December 22, 2016

Last Update Submitted That Met QC Criteria

December 21, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 12/2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Upper Gastrointestinal Endoscopy

Clinical Trials on propofol-ketamine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe