Upper Gastrointestinal EndoscopyPhase 4NCT07190612
Efficacy of Propofol Combination With Either Ketamine, Dexmedetomidine or Midazolam for Sedation During Upper Gastrointestinal Endoscopic Procedures
A Phase 4 study testing Dexmedetomidine and propofol, Midazolam and propofol and ketamine and propofol in people with Upper Gastrointestinal Endoscopy and Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The investigators are comparing the efficacy of three different sedative agents in gastrointestinal endoscopic procedures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Gastrointestinal Endoscopy, Anesthesia
- What is being tested?
- Dexmedetomidine and propofol, Midazolam and propofol and ketamine and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Dec 2024to 8 Apr 2026
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female patients aged between 18 and 65 years
- Patients who are scheduled for elective upper gastrointestinal endoscopic procedures with sedation
- Patients who are classified as ASA (American Society of Anesthesiologists) I and II
Who cannot join
- Patient's refusal to participate
- Respiratory compromise as patients with respiratory failure or with active chest conditions, e.g., bronchial asthma or pneumonia
- Cardiovascular compromise including heart failure and shocked patients
- Severe uncontrolled hematemesis with shock or risk of aspiration.
- Patients who are allergic or have any contraindications to any of the used drugs.
- Patients who have a chronic neuropsychiatric disorder or are on a neuropsychiatric drug.
- Patients on long-term sedative medication have a history of drug or alcohol abuse.
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Propofol Combination With Either Ketamine, Dexmedetomidine or Midazolam for Sedation During Upper Gastrointestinal Endoscopic Procedures: A Prospective, Randomized, Comparative Study
The investigators are comparing the efficacy of three different sedative agents in gastrointestinal endoscopic procedures.
Read the detailed description
The investigators aim to compare the efficacy of ketamine-propofol, dexmedetomidine-propofol, and midazolam-propofol combinations as procedural sedative agents for adult patients undergoing elective upper gastrointestinal endoscopic procedures.
- Conditions
- Upper Gastrointestinal Endoscopy, Anesthesia
- Being tested
- Dexmedetomidine and propofol, Midazolam and propofol, ketamine and propofol
- Keywords
- sedation, ketamine, dexmetomidine, propofol, upper endoscopy, anesthesia, midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine and propofolDrug
Also called Precedex, Diprivan
Dexmedetomidine infusion syringe (50mls): will be filled with 2mls of dexmedetomidine (200µg) diluted in 48 ml of 0.9% normal saline to make a final volume of 50mls and a final dexmedetomidine concentration of 4µg/ml. It will be infused as 1µg
/kg/hr iv. Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol (200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 minutes, then infused at a rate of 0.5mg/kg/hr.
Midazolam and propofolDrug
Also called Dormicum, Diprivan
Midazolam infusion syringe (50mls): will be filled with 10mls of Midazolam (50mg) diluted in 40mls 0.9% normal saline to make a final volume of 50mls to reach a final midazolam concentration of 1mg/ml. It will be administered as a bolus dose of 0.05 mg/kg iv over 2 minutes then infused at a rate of 0.025mg/kg/hr. Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol (200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 minutes, then infused at a rate of 0.5mg/kg/hr.
ketamine and propofolDrug
Also called Ketam
Ketamine infusion syringe (50mls): will be filled with 2mls of ketamine (100mg) diluted in 48mls 0.9% normal saline to make a final volume of 50mls to reach a final ketamine concentration of 2mg/ml. It will be administered as a bolus dose of 0.25 mg/kg iv then infused at a rate of 0.25mg/kg/hr. Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol (200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 minutes, then infused at a rate of 0.5mg/kg/hr.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Dexmedetomidine (200 µg/2ml vial) + Propofol (1% 20 mls ampoule) Receives: Drug: Dexmedetomidine and propofol |
| Group 2 | Experimental | Ketamine (50mg/1ml vial) + Propofol (1% 20 mls ampoule) Receives: Drug: ketamine and propofol |
| Group 3 | Experimental | Midazolam (5mg/1ml ampoule) + Propofol (1% 20 mls ampoule) Receives: Drug: Midazolam and propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
The time from the stoppage of the drug infusions till achieving a score of≥9 according to the modified Aldrete score.
Measured: From end of drug infusion until recovery (defined as modified Aldrete score ≥9), assessed up to 24 hours postoperatively.
Induction time
The time to reach a sedation level of ≥ 4 on Ramsay's sedation score.
Measured: Preoperatively - before the surgery
Secondary outcomes (8)
Mean arterial pressure (MAP)(mmHg)
systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg) recorded to calculate the Mean arterial pressure
Measured: perioperatively
Ramsay Sedation Scale
All patients will be targeted to reach deep sedation defined as a Ramsay Sedation Scale score of ≥4 (scale range: 1-6; 1 = anxious/awake, 6 = no response to stimuli).
Measured: Every 5 minutes from the start of the procedure until its completion, assessed up to 4 hours.
Endoscopist satisfaction
Endoscopist assessment of the sedation as excellent/good/not bad/bad
Measured: Perioperatively
Endoscopy procedure time
The duration of time the endoscope was in the oral orifice.
Measured: Peri- operatively
Rescue propofol total doses (mg)
In the case of RSS<4 or if the patient shows limb movement at any time within the procedure, propofol 20 mg IV increments will be given, and total given doses in mg will be recorded
Measured: Perioperatively
Sedation-related adverse effects (SRAEs) and complications
Any incidence of respiratory (e.g. apnea, desaturation) or hemodynamic compromise (e.g hypotension, bradycardia, tachycardia, arrhythmia, cardiac arrest) or any other adverse effects (e.g. nausea, vomiting, allergy, seizure, recovery agitation, and delayed recovery) will be managed accordingly and documented.
Measured: Perioperatively
Heart rate
(beats/min)
Measured: Perioperatively
Peripheral oxygen saturation (SPO2)
oxygen %
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start12 Dec 2024
- Primary completion6 Apr 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three study groups: propofol in combination with either: midazolam, dexmetomidazine, or ketamine.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hazem Mohammad, Msc., Principal investigator, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190612
- Sponsor's protocol ID
- FMASU MD228/2024
- Status last verified
- Sep 2024
- First submitted
- 24 Jul 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Propofol Combination With Either Ketamine, Dexmedetomidine or Midazolam for Sedation During Upper Gastrointestinal Endoscopic Procedures: A Prospective, Randomized, Comparative Study
- ClinicalTrials.gov ID
- NCT07190612
- Acronym / sponsor ID
- FMASU MD228/2024
- Conditions
- Upper Gastrointestinal Endoscopy, Anesthesia
- Keywords
- sedation, ketamine, dexmetomidine, propofol, upper endoscopy, anesthesia, midazolam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 24 Sep 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.
The investigators are comparing the efficacy of three different sedative agents in gastrointestinal endoscopic procedures.
Detailed description
The investigators aim to compare the efficacy of ketamine-propofol, dexmedetomidine-propofol, and midazolam-propofol combinations as procedural sedative agents for adult patients undergoing elective upper gastrointestinal endoscopic procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Three study groups: propofol in combination with either: midazolam, dexmetomidazine, or ketamine.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Dexmedetomidine and propofolDexmedetomidine (200 µg/2ml vial) + Propofol (1% 20 mls ampoule) |
| Group 2 | Experimental | Drug: ketamine and propofolKetamine (50mg/1ml vial) + Propofol (1% 20 mls ampoule) |
| Group 3 | Experimental | Drug: Midazolam and propofolMidazolam (5mg/1ml ampoule) + Propofol (1% 20 mls ampoule) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both male and female patients aged between 18 and 65 years
- Patients who are scheduled for elective upper gastrointestinal endoscopic procedures with sedation
- Patients who are classified as ASA (American Society of Anesthesiologists) I and II
Key exclusion criteria (8 listed)
- Patient's refusal to participate
- Respiratory compromise as patients with respiratory failure or with active chest conditions, e.g., bronchial asthma or pneumonia
- Cardiovascular compromise including heart failure and shocked patients
- Severe uncontrolled hematemesis with shock or risk of aspiration.
- Patients who are allergic or have any contraindications to any of the used drugs.
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 and propofolAlso: Precedex, DiprivanDexmedetomidine infusion syringe (50mls): will be filled with 2mls of dexmedetomidine (200µg) diluted in 48 ml of 0.9% normal saline to make a final volume of 50mls and a final dexmedetomidine concentration of 4µg/ml. It will be infused as 1µg /kg/hr iv. Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol (200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 minutes, then infused at a rate of 0.5mg/kg/hr. | Drug | Group 1 |
| Midazolam and propofolAlso: Dormicum, DiprivanMidazolam infusion syringe (50mls): will be filled with 10mls of Midazolam (50mg) diluted in 40mls 0.9% normal saline to make a final volume of 50mls to reach a final midazolam concentration of 1mg/ml. It will be administered as a bolus dose of 0.05 mg/kg iv over 2 minutes then infused at a rate of 0.025mg/kg/hr. Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol (200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 minutes, then infused at a rate of 0.5mg/kg/hr. | Drug | Group 3 |
| ketamine and propofolAlso: KetamKetamine infusion syringe (50mls): will be filled with 2mls of ketamine (100mg) diluted in 48mls 0.9% normal saline to make a final volume of 50mls to reach a final ketamine concentration of 2mg/ml. It will be administered as a bolus dose of 0.25 mg/kg iv then infused at a rate of 0.25mg/kg/hr. Propofol infusion syringe (50mls): will be filled with 20mls of 1% propofol (200mg) diluted in 30mls 0.9% normal saline to make a final volume of 50mls and a final propofol concentration of 4mg/ml. It will be iv administered as 0.5 mg/kg slow iv for 10 minutes, then infused at a rate of 0.5mg/kg/hr. | Drug | Group 2 |
Primary outcome
Recovery time
Time frame: From end of drug infusion until recovery (defined as modified Aldrete score ≥9), assessed up to 24 hours postoperatively.
The time from the stoppage of the drug infusions till achieving a score of≥9 according to the modified Aldrete score.
Induction time
Time frame: Preoperatively - before the surgery
The time to reach a sedation level of ≥ 4 on Ramsay's sedation score.
8 secondary outcomes
Mean arterial pressure (MAP)(mmHg)
Time frame: perioperatively
Ramsay Sedation Scale
Time frame: Every 5 minutes from the start of the procedure until its completion, assessed up to 4 hours.
Endoscopist satisfaction
Time frame: Perioperatively
Endoscopy procedure time
Time frame: Peri- operatively
Rescue propofol total doses (mg)
Time frame: Perioperatively
Sedation-related adverse effects (SRAEs) and complications
Time frame: Perioperatively
Heart rate
Time frame: Perioperatively
Peripheral oxygen saturation (SPO2)
Time frame: Perioperatively
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 22 Jun 2026.
- Individual participant dataSharing planned: No. Due to confidentiality
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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.
Hazem Mohammad, Msc. principal investigator
AinShams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and propofol, Midazolam and propofol and ketamine and propofol in people with Upper Gastrointestinal Endoscopy and Anesthesia, run by Ain Shams 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 8 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 22 Jun 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recovery time (time frame: From end of drug infusion until recovery (defined as modified Aldrete score ≥9), assessed up to 24 hours postoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.