Procedural Sedation
Conditions
Keywords
Emergency Department, Procedure sedation, Ketamine, Propofol, Ketofol, Ketadex, Dexmedetomidine
Brief 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. 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.
Interventions
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.
DRUGpropofol
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.
DRUGDexmedetomidine
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.
DRUGNormal Saline
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.
Sponsors
Sultan Qaboos University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, treating clinicians, investigators, and outcome assessors will be blinded to treatment allocation. An unblinded study nurse will prepare the study medications according to the randomized allocation. A double-dummy design will be used. Each participant will receive two study syringes: an intravenous bolus syringe and an infusion syringe administered over 10 minutes. The bolus syringe will be covered with an opaque white label to conceal its contents. The unblinded nurse responsible for study drug preparation will not participate in clinical assessment or outcome assessment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Respiratory Adverse Events | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Time | From procedure completion to achievement of Aldrete score ≥9, assessed up to 60 minutes. | Time in minutes from the end of the procedure to achievement of an Aldrete recovery score ≥9. |
| Incidence of Hemodynamic Adverse Events | Baseline (pre-sedation) and every 5 minutes up to 60 minutes after procedure completion | 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). |
| Pain Score | At achievement of an Aldrete recovery score ≥9 (within 60 minutes after procedure completion) and at 30 minutes after procedure completion. | 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. |
| Incidence of Emergence Reactions | From initiation of study medication up to 60 minutes after procedure completion. | 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. |
| Incidence of Nausea and Vomiting | From procedure completion up to 60 minutes. | Incidence of nausea and/or vomiting occurring following administration of the study medications. |
Countries
Oman
Contacts
CONTACTAshraf Fathy Elshehry, Fellowship Royal college of Em
PRINCIPAL_INVESTIGATORAshraf Fathy Elshehry, FRCEM-UK
University Medical City / Sultan Qaboos University Hospital
Outcome results
None listed