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Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy Gastrointestinal Endoscopy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03235609
Enrollment
60
Registered
2017-08-01
Start date
2017-08-16
Completion date
2018-08-15
Last updated
2017-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation

Brief summary

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

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.

Interventions

DRUGFentanyl

fentanyl used with propofol for sedation

DRUGKetamine

ketamine used with propofol for sedation

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

double blind

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
incidence of desaturationup to 2 days after operationwhen oxygen saturation below 90%

Contacts

Primary ContactMohamed Aly
galalm1967@yahoo.com00201062011126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026