Procedural SedationPhase 4NCT07874919
Ketadex Versus Ketofol for Adult Procedural Sedation in the Emergency Department.
A Phase 4 study testing Ketamine (1 mg/kg), propofol and Dexmedetomidine in people with Procedural Sedation, run by Sultan Qaboos University at 1 site in Oman.
Trial summary
This randomized controlled trial will compare two medication combinations, ketamine-dexmedetomidine (Ketadex) and ketamine-propofol (Ketofol), for procedural sedation in adults undergoing painful procedures in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Procedural Sedation
- What is being tested?
- Ketamine (1 mg/kg), propofol and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteOman
- Study dates
- 10 Oct 2026to 1 Mar 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Requiring procedural sedation for a diagnostic or therapeutic procedure in the Emergency Department.
- ASA class I-II, or stable ASA class III at the treating physician's discretion.
- Procedure anticipated to last <30 minutes.
- Able to provide informed consent.
Who cannot join
- Known allergy or hypersensitivity to propofol, egg/soy, ketamine, or dexmedetomidine.
- Hemodynamic instability (systolic blood pressure <90 mmHg before sedation).
- Severe coronary artery disease or cardiomyopathy.
- Severe asthma or COPD with acute decompensation.
- Baseline hypoxia or requirement for ventilatory support.
- Pregnancy.
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- Intracranial hypertension or glaucoma.
- Active psychosis or hallucinations.
- Current use of significant beta-blockers or clonidine.
- Administration of sedative or opioid medication before enrollment that, in the clinician's judgment, is likely to have a clinically significant residual effect at the time of procedural sedation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oman1 site
Sultan Qaboos University Hospital- UMC
Seeb, Muḩāfaz̧at Masqaţ, 123
Ashraf Fathy Elshehry, FRCEM-UK, 0096899896754, elshehry@squ.edu.om
About this study
Official title: Ketadex Versus Ketofol for Adult Procedural Sedation in the Emergency Department: A Randomized Controlled Trial
This randomized controlled trial will compare two medication combinations, ketamine-dexmedetomidine (Ketadex) and ketamine-propofol (Ketofol), for procedural sedation in adults undergoing painful procedures in the emergency department. The primary objective is to compare the respiratory safety of the two sedation regimens, particularly the occurrence of hypoxic events and the need for airway interventions. Participants will be randomly assigned to receive either Ketadex or Ketofol. The study will also compare recovery time, hemodynamic effects, pain, emergence reactions, nausea and vomiting, and other adverse events between the two groups. The study will be conducted in the Emergency Department at Sultan Qaboos University Hospital, University Medical City, Oman.
- Conditions
- Procedural Sedation
- Being tested
- Ketamine (1 mg/kg), propofol, Dexmedetomidine, Normal Saline
- Keywords
- Emergency Department, Procedure sedation, Ketamine, Propofol, Ketofol, Ketadex, Dexmedetomidine
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine (1 mg/kg)Drug
Ketamine 1 mg/kg will be administered intravenously as a bolus. In the Ketofol arm, ketamine will be mixed with propofol 1 mg/kg in the same syringe. In the Ketadex arm, ketamine 1 mg/kg will be administered without propofol in the bolus syringe. The bolus syringe will be covered with an opaque white label to maintain blinding.
propofolDrug
Propofol 1 mg/kg will be mixed with ketamine 1 mg/kg in the same syringe and administered as an intravenous bolus to participants assigned to the Ketofol arm. The syringe will be covered with an opaque white label to maintain blinding.
DexmedetomidineDrug
Dexmedetomidine 1 microgram/kg will be administered intravenously over 10 minutes using an infusion pump or syringe driver to participants assigned to the Ketadex arm.
Normal SalineDrug
Normal saline, 15 mL, will be administered intravenously over 10 minutes using an infusion pump or syringe driver to participants assigned to the Ketofol arm. It will serve as the placebo infusion in the double-dummy design.
| Study group | Role | What they receive |
|---|---|---|
| Ketofol | Experimental | Participants randomized to the Ketofol arm will receive ketamine 1 mg/kg plus propofol 1 mg/kg as an intravenous bolus, followed by 15 mL of normal saline placebo administered intravenously over 10 minutes. Receives: Drug: Ketamine (1 mg/kg); Drug: propofol; Drug: Normal Saline |
| Ketadex | Experimental | Participants randomized to the Ketadex arm will receive ketamine 1 mg/kg as an intravenous bolus, followed by dexmedetomidine 1 microgram/kg administered intravenously over 10 minutes. Receives: Drug: Ketamine (1 mg/kg); Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Respiratory Adverse Events
Incidence of respiratory adverse events, defined as oxygen desaturation (SpO₂ <94% for >15 seconds) and/or requirement for airway intervention (jaw thrust, bag-valve-mask ventilation, or intubation)
Measured: From initiation of study medication up to 60 minutes after procedure completion
Secondary outcomes (5)
Recovery Time
Time in minutes from the end of the procedure to achievement of an Aldrete recovery score ≥9.
Measured: From procedure completion to achievement of Aldrete score ≥9, assessed up to 60 minutes.
Incidence of Hemodynamic Adverse Events
Effects: Changes in blood pressure and heart rate from baseline, including incidence of hypotension (SBP <90 mmHg or >20% decrease from baseline), bradycardia (HR <50 bpm), and tachycardia (HR >120 bpm).
Measured: Baseline (pre-sedation) and every 5 minutes up to 60 minutes after procedure completion
Pain Score
Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0-10, where 0 indicates no pain and 10 indicates the worst imaginable pain) upon achieving an Aldrete recovery score ≥9 and 30 minutes after procedure completion. We will also record the administration of additional rescue analgesic medication during the post-procedure observation period.
Measured: At achievement of an Aldrete recovery score ≥9 (within 60 minutes after procedure completion) and at 30 minutes after procedure completion.
Incidence of Emergence Reactions
Incidence of emergence reactions following procedural sedation, including agitation, hallucinations, confusion, or other behavioral disturbances occurring during emergence from sedation. We will record and compare the proportion of participants experiencing at least one emergence reaction between the two study groups.
Measured: From initiation of study medication up to 60 minutes after procedure completion.
Incidence of Nausea and Vomiting
Incidence of nausea and/or vomiting occurring following administration of the study medications.
Measured: From procedure completion up to 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ashraf Elshehry, Sultan Qaboos University
- Investigators
- Ashraf Fathy Elshehry, FRCEM-UK, Principal investigator, University Medical City / Sultan Qaboos University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874919
- Sponsor's protocol ID
- MREC# 3949
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data with researchers outside the study team. Study findings will be disseminated in aggregate form through scientific presentations and publications.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketadex Versus Ketofol for Adult Procedural Sedation in the Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07874919
- Acronym / sponsor ID
- MREC# 3949
- Conditions
- Procedural Sedation
- Keywords
- Emergency Department, Procedure sedation, Ketamine, Propofol, Ketofol, Ketadex, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 15 Oct 2026 (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 randomized controlled trial will compare two medication combinations, ketamine-dexmedetomidine (Ketadex) and ketamine-propofol (Ketofol), for procedural sedation in adults undergoing painful procedures in the emergency department. The primary objective is to compare the respiratory safety of the two sedation regimens, particularly the occurrence of hypoxic events and the need for airway interventions. Participants will be randomly assigned to receive either Ketadex or Ketofol. The study will also compare recovery time, hemodynamic effects, pain, emergence reactions, nausea and vomiting, and other adverse events between the two groups. The study will be conducted in the Emergency Department at Sultan Qaboos University Hospital, University Medical City, Oman.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketofol | Experimental | Drug: Ketamine (1 mg/kg), Drug: propofol, Drug: Normal SalineParticipants randomized to the Ketofol arm will receive ketamine 1 mg/kg plus propofol 1 mg/kg as an intravenous bolus, followed by 15 mL of normal saline placebo administered intravenously over 10 minutes. |
| Ketadex | Experimental | Drug: Ketamine (1 mg/kg), Drug: DexmedetomidineParticipants randomized to the Ketadex arm will receive ketamine 1 mg/kg as an intravenous bolus, followed by dexmedetomidine 1 microgram/kg administered intravenously over 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Requiring procedural sedation for a diagnostic or therapeutic procedure in the Emergency Department.
- ASA class I-II, or stable ASA class III at the treating physician's discretion.
- Procedure anticipated to last <30 minutes.
- Able to provide informed consent.
Key exclusion criteria (10 listed)
- Known allergy or hypersensitivity to propofol, egg/soy, ketamine, or dexmedetomidine.
- Hemodynamic instability (systolic blood pressure <90 mmHg before sedation).
- Severe coronary artery disease or cardiomyopathy.
- Severe asthma or COPD with acute decompensation.
- Baseline hypoxia or requirement for ventilatory support.
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 |
|---|---|---|
| Ketamine (1 mg/kg)Ketamine 1 mg/kg will be administered intravenously as a bolus. In the Ketofol arm, ketamine will be mixed with propofol 1 mg/kg in the same syringe. In the Ketadex arm, ketamine 1 mg/kg will be administered without propofol in the bolus syringe. The bolus syringe will be covered with an opaque white label to maintain blinding. | Drug | Ketadex, Ketofol |
| propofolPropofol 1 mg/kg will be mixed with ketamine 1 mg/kg in the same syringe and administered as an intravenous bolus to participants assigned to the Ketofol arm. The syringe will be covered with an opaque white label to maintain blinding. | Drug | Ketofol |
| DexmedetomidineDexmedetomidine 1 microgram/kg will be administered intravenously over 10 minutes using an infusion pump or syringe driver to participants assigned to the Ketadex arm. | Drug | Ketadex |
| Normal SalineNormal saline, 15 mL, will be administered intravenously over 10 minutes using an infusion pump or syringe driver to participants assigned to the Ketofol arm. It will serve as the placebo infusion in the double-dummy design. | Drug | Ketofol |
Primary outcome
Incidence of Respiratory Adverse Events
Time frame: From initiation of study medication up to 60 minutes after procedure completion
Incidence of respiratory adverse events, defined as oxygen desaturation (SpO₂ <94% for >15 seconds) and/or requirement for airway intervention (jaw thrust, bag-valve-mask ventilation, or intubation)
5 secondary outcomes
Recovery Time
Time frame: From procedure completion to achievement of Aldrete score ≥9, assessed up to 60 minutes.
Incidence of Hemodynamic Adverse Events
Time frame: Baseline (pre-sedation) and every 5 minutes up to 60 minutes after procedure completion
Pain Score
Time frame: At achievement of an Aldrete recovery score ≥9 (within 60 minutes after procedure completion) and at 30 minutes after procedure completion.
Incidence of Emergence Reactions
Time frame: From initiation of study medication up to 60 minutes after procedure completion.
Incidence of Nausea and Vomiting
Time frame: From procedure completion up to 60 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data with researchers outside the study team. Study findings will be disseminated in aggregate form through scientific presentations and publications.
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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.
Ashraf Fathy Elshehry, FRCEM-UK principal investigator
University Medical City / Sultan Qaboos University Hospital
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 Ketamine (1 mg/kg), propofol and Dexmedetomidine in people with Procedural Sedation, run by Sultan Qaboos University at 1 site in Oman.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 15 Oct 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 Oman. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashraf Fathy Elshehry, Fellowship Royal college of Em (0096899896754, elshehry@squ.edu.om), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Respiratory Adverse Events (time frame: From initiation of study medication up to 60 minutes after procedure completion). 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 15 Oct 2026.