PropofolNCT06756594
Efficacy of Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation
A study testing Dexmedetomidine-Propofol and Ketamine-Propofol in people with Propofol, run by Sohag University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Propofol
- What is being tested?
- Dexmedetomidine-Propofol and Ketamine-Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Nov 2024to 11 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status I to II.
- Age between 18 and 60 years.
- Both sexes.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Propofol
- Being tested
- Dexmedetomidine-Propofol, Ketamine-Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine-PropofolDrug
efficacy of sedation with Dexmedetomidine-Propofol combination in the upper or lower gastrointestinal system endoscopy.
Ketamine-PropofolDrug
efficacy of sedation with Ketamine-Propofol combination in the upper or lower gastrointestinal system endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine-Propofol for sedation during gastrointestinal endoscopy | Active comparator | efficacy of sedation with Dexmedetomidine-Propofol combination in the upper or lower gastrointestinal system endoscopy. Receives: Drug: Dexmedetomidine-Propofol |
| Ketamine-Propofol for sedation during gastrointestinal endoscopy | Active comparator | efficacy of sedation with Ketamine-Propofol combination in the upper or lower gastrointestinal system endoscopy. Receives: Drug: Ketamine-Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative and postoperative monitoring of sedation during upper or lower gastrointestinal system endoscopy.
Sedation level
Measured: every 5 minutes intraoperative and every 15 minutes for 2 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start12 Nov 2024
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PropofolStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hany Hamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756594
- Sponsor's protocol ID
- Soh-Med-24-11-02MS
- Status last verified
- May 2026
- First submitted
- 26 Dec 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33285707Zhang 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.
PubMed 27284342Chang 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.
PubMed 28130737
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation During Gastrointestinal Endoscopy
- ClinicalTrials.gov ID
- NCT06756594
- Acronym / sponsor ID
- Soh-Med-24-11-02MS
- Conditions
- Propofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine-Propofol for sedation during gastrointestinal endoscopy | Active comparator | Drug: Dexmedetomidine-Propofolefficacy of sedation with Dexmedetomidine-Propofol combination in the upper or lower gastrointestinal system endoscopy. |
| Ketamine-Propofol for sedation during gastrointestinal endoscopy | Active comparator | Drug: Ketamine-Propofolefficacy of sedation with Ketamine-Propofol combination in the upper or lower gastrointestinal system endoscopy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical status I to II.
- Age between 18 and 60 years.
- Both sexes.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine-Propofolefficacy of sedation with Dexmedetomidine-Propofol combination in the upper or lower gastrointestinal system endoscopy. | Drug | Dexmedetomidine-Propofol for sedation during gastrointestinal endoscopy |
| Ketamine-Propofolefficacy of sedation with Ketamine-Propofol combination in the upper or lower gastrointestinal system endoscopy. | Drug | Ketamine-Propofol for sedation during gastrointestinal endoscopy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 33285707Tekeli 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.
- Background: PubMed 27284342Zhang 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.
- Background: PubMed 28130737Chang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine-Propofol and Ketamine-Propofol in people with Propofol, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06756594, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.