NCT02863861

Brief 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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

August 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2016

Enrollment Period

3 months

First QC Date

August 8, 2016

Last Update Submit

December 21, 2016

Conditions

Upper Gastrointestinal Endoscopy

Keywords

SedationPediatric Patients

Outcome Measures

Primary Outcomes (1)

  • length of stay in PACU

    three months

Study Arms (2)

Group PK

EXPERIMENTAL

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

Group DK

EXPERIMENTAL

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

Dexmedetomidine-ketamineDRUG
Group DK
propofol-ketamineDRUG
Group PK

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university- faculty of medicine- department of anesthesia, intensive care and pain management

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 33293038DERIVED

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Department of Anesthesiology, Intensive Care, and Pain Management, Faculty of Medicine, Ain-Shams University

Study Record Dates

First Submitted

August 8, 2016

First Posted

August 11, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Last Updated

December 22, 2016

Record last verified: 2016-12

Locations

EG(1)