NCT03235609

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

August 16, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

July 27, 2017

Last Update Submit

August 1, 2017

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

  • incidence of desaturation

    when oxygen saturation below 90%

    up to 2 days after operation

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV.

Drug: Fentanyl

Ketamine

ACTIVE COMPARATOR

Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV.

Drug: Ketamine

Interventions

FentanylDRUG

fentanyl used with propofol for sedation

Also known as: Fentanyl Citrate
Fentanyl
KetamineDRUG

ketamine used with propofol for sedation

Also known as: katalar
Ketamine

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1055/s-2004-826144.

    PMID: 15692933BACKGROUND

MeSH Terms

Interventions

FentanylKetamine

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Mohamed Aly

CONTACT

00201062011126galalm1967@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 1, 2017

Study Start

August 16, 2017

Primary Completion

June 15, 2018

Study Completion

August 15, 2018

Last Updated

August 3, 2017

Record last verified: 2017-08