- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07423676
Comparison Between Two Drugs in Sedation of Upper GI Endoscopy
Ketamine - Dexmedetomidine(Ketodex) Versus Propofol -Midazolam for Sedation in Patients Undergoing Upper Gastrointestinal Endoscopy
The goal of this clinical trial is to compare time of sedation between two drugs administered to patients undergoing upper gastrointestinal endoscopy Primary outcome : Time of sedation : is the time to reach sedation score of 5 according to modified Ramsay sedation score starting from the time of injecting bolts dose of study drugs
Secondary outcome :
- Recovery time :is the time to reach score 2 of modified Ramsay sedation score starting from injecting bolus dose of study drugs .
- Hemodynamics (MAP,HR) & oxygen saturation
- Drug side effects (nausea,vomitting,agitation)
- Endoscopist satisfaction
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed Esam Hamad, Register
- Phone Number: +201095529439
- Email: tahawy188@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- Patient acceptance
- Adults aged 21-60 years.
- Both sexes
- BMI<35 kg/m2
- ASA physical status :I& II
- Patients Undergoing Gastrointestinal endoscopy
- Duration <30mintues
Exclusion Criteria:
• Known allergy to any of the study drugs
- Unstable Cardiovascular disease
- Moderate to severe respiratory diseases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Ketamine dexmetamodine and propofol midazolam
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison between time of sedation between ketamine Dexametomidine and propofol midazolam in sedation of GI endoscopy
Time Frame: Baseline
|
Time of sedation :is the time to reach sedation score of 5 according to modified Ramsay sedation score starting from the time of injecting bolts dose of study drugs
|
Baseline
|
|
Comparison time of sedation between ketamine Dexametomidine and propofol midazolam in sedation of GI endoscopy
Time Frame: Baseline
|
Time of sedation:is the time to reach sedation score of 5 according to modified Ramsay sedation score starting from the time of injecting bolts dose of study drugs
|
Baseline
|
|
Comparison of time of sedation between ketamine Dexametomidine g
Time Frame: Basline
|
• Time of sedation :is the time to reach score 5 of modified Ramsay sedation score starting from injecting bolus dose of study drugs .
|
Basline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Doaa Mohamed Farid, MD, Doaa mohamed Farid
- Study Director: Rehab Abdalla Wahdan, MD, Rehab Abdalla Wahdan
- Principal Investigator: Olfat Monium Abraham, MD, Olfat abdelmonium Ebrahim
Publications and helpful links
General Publications
- Rey JF. Sedation for upper gastrointestinal endoscopy: as much as possible, or without? Endoscopy. 1996 Mar;28(3):308-9. doi: 10.1055/s-2007-1005460. No abstract available.
- Sachdeva A, Bhalla A, Sood A, Duseja A, Gupta V. The effect of sedation during upper gastrointestinal endoscopy. Saudi J Gastroenterol. 2010 Oct-Dec;16(4):280-4. doi: 10.4103/1319-3767.70616.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Sedation in GI endoscopy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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