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NCT03235609 Clinical Trial

Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy

Sedation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03235609
Other study ID # 17100212
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 27, 2017
Last updated August 1, 2017
Start date August 16, 2017
Est. completion date August 15, 2018

Study information
Verified date August 2017
Source Assiut University
Contact Mohamed Aly
Phone 00201062011126
Email galalm1967@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date August 15, 2018
Est. primary completion date June 15, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 16 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Fentanyl
fentanyl used with propofol for sedation
• Ketamine
ketamine used with propofol for sedation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Michaud L; Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Sedation for diagnostic upper gastrointestinal endoscopy: a survey of the Francophone Pediatric Hepatology, Gastroenterology, and Nutrition Group. Endoscopy. 2005 Feb;37(2):167-70. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of desaturation when oxygen saturation below 90% up to 2 days after operation
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