Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy

August 1, 2017 updated by: Mohamed galal aly, Assiut University

Propofol-Ketamine vs. Propofol-Fentanyl for Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy

comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It is a prospective double blinded controlled study that will be carried out on 60 pediatric patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:- Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

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

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatric patients undergoing diagnostic GIT endoscopy
  • ASA I-II

Exclusion Criteria:

  • Emergency endoscopy
  • Respiratory infection and hyperactive airways
  • History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs
  • Morbid obesity, and neuropsychiatric disorders

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fentanyl
Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV.
Drug: Fentanyl
fentanyl used with propofol for sedation
Other Names:
  • Fentanyl Citrate
Active Comparator: Ketamine
Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV.
Drug: Ketamine
ketamine used with propofol for sedation
Other Names:
  • katalar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of desaturation
Time Frame: up to 2 days after operation
when oxygen saturation below 90%
up to 2 days after operation

Collaborators and Investigators

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

Sponsor

Assiut 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 (Anticipated)

August 16, 2017

Primary Completion (Anticipated)

June 15, 2018

Study Completion (Anticipated)

August 15, 2018

Study Registration Dates

First Submitted

July 27, 2017

First Submitted That Met QC Criteria

July 31, 2017

First Posted (Actual)

August 1, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17100212

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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