A Phase 4 interventional study of Ketamine (1 mg/kg) and propofol in Procedural Sedation, sponsored by Sultan Qaboos University. Not yet recruiting at 1 site in Oman. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Sultan Qaboos University · Phase 4, Interventional, and Treatment
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.
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This study's planned enrollment of 100 is below the median of 144 across 948 interventional studies indexed under Emergencies.
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Exclusion Criteria:
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.
Drug: Ketamine (1 mg/kg) · Drug: propofol · Drug: Normal Saline
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.
Drug: Ketamine (1 mg/kg) · Drug: Dexmedetomidine
Drug page: Ketamine
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.
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.
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 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.
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)
Time frame: From initiation of study medication up to 60 minutes after procedure completion
Recovery Time
Time in minutes from the end of the procedure to achievement of an Aldrete recovery score ≥9.
Time frame: 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).
Time frame: 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.
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
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.
Time frame: 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.
Time frame: From procedure completion up to 60 minutes.
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Propofol · Dexmedetomidine
Sultan Qaboos University