- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06756594
Efficacy of Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation
May 21, 2026 updated by: Ahmed Hany Hamed, Sohag University
Efficacy of Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation During Gastrointestinal Endoscopy
This study aims to compare efficacy of sedation between Dexmedetomidine-Propofol and Ketamine-Propofol combinations in the upper or lower gastrointestinal system endoscopy.
We compare between 2 combinations as regard hemodynamic stability, post operative side effects as occurrence of delirium, nausea, vomiting, headache, hallucination or agitation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sohag, Egypt
- Sohag University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- American Society of Anesthesiologists physical status I to II.
- Age between 18 and 60 years.
- Both sexes.
Exclusion Criteria:
- Having severe heart, lung, liver disease, kidney failure, or bleeding disorder.
- Patients having fever, hypothermia or infection, electrolyte disorders, such as hypokalemia and hypocalcaemia, acid-base disorder, allergy to drugs to be used.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Dexmedetomidine-Propofol for sedation during gastrointestinal endoscopy
efficacy of sedation with Dexmedetomidine-Propofol combination in the upper or lower gastrointestinal system endoscopy.
|
efficacy of sedation with Dexmedetomidine-Propofol combination in the upper or lower gastrointestinal system endoscopy.
|
|
Active Comparator: Ketamine-Propofol for sedation during gastrointestinal endoscopy
efficacy of sedation with Ketamine-Propofol combination in the upper or lower gastrointestinal system endoscopy.
|
efficacy of sedation with Ketamine-Propofol combination in the upper or lower gastrointestinal system endoscopy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intraoperative and postoperative monitoring of sedation during upper or lower gastrointestinal system endoscopy.
Time Frame: every 5 minutes intraoperative and every 15 minutes for 2 hours postoperative.
|
Sedation level
|
every 5 minutes intraoperative and every 15 minutes for 2 hours postoperative.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Tekeli AE, Oguz AK, Tuncdemir YE, Almali N. Comparison of dexmedetomidine-propofol and ketamine-propofol administration during sedation-guided upper gastrointestinal system endoscopy. Medicine (Baltimore). 2020 Dec 4;99(49):e23317. doi: 10.1097/MD.0000000000023317.
- Zhang F, Sun HR, Zheng ZB, Liao R, Liu J. Dexmedetomidine versus midazolam for sedation during endoscopy: A meta-analysis. Exp Ther Med. 2016 Jun;11(6):2519-2524. doi: 10.3892/etm.2016.3186. Epub 2016 Mar 24.
- Chang ET, Certal V, Song SA, Zaghi S, Carrasco-Llatas M, Torre C, Capasso R, Camacho M. Dexmedetomidine versus propofol during drug-induced sleep endoscopy and sedation: a systematic review. Sleep Breath. 2017 Sep;21(3):727-735. doi: 10.1007/s11325-017-1465-x. Epub 2017 Jan 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 12, 2024
Primary Completion (Actual)
June 11, 2025
Study Completion (Actual)
June 11, 2025
Study Registration Dates
First Submitted
December 26, 2024
First Submitted That Met QC Criteria
December 26, 2024
First Posted (Actual)
January 3, 2025
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 21, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Anesthetics
- Central Nervous System Depressants
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Neurotransmitter Agents
- Hypnotics and Sedatives
- Anesthetics, Intravenous
- Anesthetics, General
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Adrenergic Agents
- Excitatory Amino Acid Agents
- Anesthetics, Dissociative
- Excitatory Amino Acid Antagonists
- Dexmedetomidine
- Propofol
- Ketamine
Other Study ID Numbers
- Soh-Med-24-11-02MS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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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