CClinicalTrials.gg
Sign In
CompletedNCT02863861Updated Dec 22, 2016

Sedation for Upper Gastrointestinal Endoscopy in Pediatric Patients

A Phase 4 interventional study of Dexmedetomidine-ketamine and propofol-ketamine in Upper Gastrointestinal Endoscopy, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 2 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-22.

Sponsored by Ain Shams University · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
2 Years to 7 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Upper Gastrointestinal Endoscopy

Keywords

  • Sedation
  • Pediatric Patients
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • American Society of Anesthesiologists ASA I-II patients aging 2-7 years.

Exclusion criteria

Exclusion Criteria:

known allergy to any of the study drugs, significant cardiovascular disease vomiting.

05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
120 participants (actual)

Study arms

  • 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

Interventions

  • DrugDexmedetomidine-ketamine
  • Drugpropofol-ketamine
06

What researchers measure

Primary outcomes

  1. length of stay in PACU

    Time frame: three months

07

Study locations

1 site
  • Ain shams university- faculty of medicine- department of anesthesia, intensive care and pain management
    Cairo, Egypt
08

References and documents

Publications

  • Amer AM, Youssef AM, El-Ozairy HS, El-Hennawy AM. [Propofol-ketamine versus dexmedetomidine-ketamine for sedation during upper gastrointestinal endoscopy in pediatric patients: a randomized clinical trial]. Braz J Anesthesiol. 2020 Nov-Dec;70(6):620-626. doi: 10.1016/j.bjan.2020.08.005. Epub 2020 Dec 5. PubMed 33293038 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02863861
Lead sponsor
Ain Shams University
Responsible party
Akram Mohamed Mohamed Amer (Lecturer in Department of Anesthesiology, Intensive Care, and Pain Management, Faculty of Medicine, Ain-Shams University, Ain Shams University) — Principal investigator
First posted
Aug 11, 2016
Start date
Sep 2016
Primary completion
Dec 2016
Last update
Dec 22, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Ain Shams University

Start the discussion