A Phase 4 interventional study of Dexmedetomidine and Propofol (Astra-Zeneca) in Chronic Subdural Hematoma, sponsored by National Institute of Neurology, Tunisia. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by National Institute of Neurology, Tunisia · Phase 4, Interventional, and Supportive care
Chronic subdural hematoma is a collection of old blood on the surface of the brain that mainly affects older adults. It is often treated by draining the blood through a small hole in the skull (burr hole), under local anesthesia combined with intravenous sedation while the patient keeps breathing spontaneously. Propofol and dexmedetomidine are the two sedatives most commonly used for this purpose.
This randomized pilot study will compare how well each drug maintains a moderate and stable level of sedation during surgery. Sixty adults will be randomly assigned to receive either propofol by target-controlled infusion or dexmedetomidine. The main outcome is the percentage of surgical time spent at the target sedation level, defined as a Richmond Agitation-Sedation Scale (RASS) score between -2 and -3.
The study will also compare the time needed to reach the target sedation, breathing and cardiovascular side effects, sedation failures, recovery time, and surgeon and anesthesiologist satisfaction. The results will be used to estimate the sample size of a future confirmatory trial.
Design: single-center, prospective, randomized (1:1), controlled, parallel-group pilot trial.
Randomization: computer-generated list in fixed blocks of 4, prepared by a person not involved in the study. Allocations are concealed in sequentially numbered, opaque, sealed envelopes opened in strict order in the operating room immediately before sedation starts.
Masking: the patient, the surgeon, and the postoperative outcome assessor are blinded to group allocation; the syringe and infusion line are covered with an opaque sleeve. The anesthesiologist, who administers the sedative and scores the intraoperative RASS, is not blinded.
Standardized sequence (identical in both arms): T0 start of sedative and sufentanil 5 µg IV; T0 + 10 min lidocaine 2% with epinephrine infiltration by the surgeon (maximum 5 mg/kg); T1 skin incision; T2 burr hole drilling; T3 end of skin closure and discontinuation of the sedative in both arms; T4 modified Aldrete score ≥ 9.
Sedation monitoring: RASS scored before sedation and every 5 minutes using a standardized procedure. Target sedation: RASS -2 to -3. If RASS ≥ +1, a cause (pain, hypoxia, bladder distension, position) is sought and treated before increasing the sedative.
Sedation failure: dose ceiling reached for at least 10 min with RASS > -2 on two consecutive assessments; persistent agitation (RASS ≥ +2 on two consecutive assessments); rescue with a non-protocol sedative; conversion to general anesthesia or intubation; persistent desaturation (SpO2 \< 92% for ≥ 30 s despite oxygen and airway maneuvers); or major hemodynamic instability requiring discontinuation of the sedative or continuous vasopressors.
Statistical analysis: modified intention-to-treat population (all randomized patients who received at least one dose of the study drug), with a supportive per-protocol analysis. After a sedation failure, all remaining time until T3 is counted as outside the target. Comparisons are exploratory and reported with 95% confidence intervals. Hemodynamic changes are analyzed using summary measures per patient.
Sample size: no data exist on the primary outcome in this setting; 30 patients per group were chosen according to published recommendations for pilot trials (Julious 2005; Whitehead 2016). Feasibility criteria: recruitment of ≥ 8 patients per month, ≥ 70% of eligible patients randomized, titration algorithm followed in ≥ 80% of patients, and complete primary outcome data in ≥ 90%.
117 studies on the registry are indexed under Hematoma, Subdural, Chronic; 50 are open to participants now.
This study's planned enrollment of 60 is below the median of 167 across 90 interventional studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →National Institute of Neurology, Tunisia is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Dexmedetomidine sedation titrated to a RASS of -2 to -3, combined with lidocaine 2% with epinephrine infiltration and a single dose of sufentanil 5 µg IV, for burr-hole surgery under local anesthesia with spontaneous breathing.
Drug: Dexmedetomidine
Propofol sedation by target-controlled infusion titrated to a RASS of -2 to -3, combined with lidocaine 2% with epinephrine infiltration and a single dose of sufentanil 5 µg IV, for burr-hole surgery under local anesthesia with spontaneous breathing.
Drug: Propofol (Astra-Zeneca)
Loading dose of 1 µg/kg over 10 minutes, then 0.6 µg/kg/h. Increased by 0.2 µg/kg/h every 10 minutes if RASS \> -2; decreased by 0.2 µg/kg/h if RASS = -4; temporarily stopped if RASS = -5, apnea or airway obstruction, and restarted at a rate reduced by 0.2 µg/kg/h once RASS ≥ -3. Range 0.2 to 1.0 µg/kg/h. Stopped at the end of skin closure.
Also known as: Precedex
Target-controlled infusion (Schnider model, effect-site mode) started at an effect-site concentration of 1.0 µg/mL. Increased by 0.3 µg/mL every 5 minutes if RASS \> -2; decreased by 0.3 µg/mL if RASS = -4 and by 0.5 µg/mL if RASS = -5, apnea, or airway obstruction. Maximum 3.0 µg/mL. No manual boluses. Stopped at the end of skin closure.
Also known as: diprivan
Percentage of time within target sedation
Percentage of the time between skin incision and end of skin closure spent with a Richmond Agitation-Sedation Scale (RASS) score between -2 and -3 (scale range -5 \[unarousable\] to +4 \[combative\]). RASS is scored every 5 minutes; each score is assumed valid until the next one. After a sedation failure, all remaining time is counted as outside the target.
Time frame: Intraoperative, from skin incision to end of skin closure (approximately 1 hour)
Time to target sedation
Time from the start of the sedative to the first RASS score between -2 and -3, in minutes.
Time frame: From start of sedation until target sedation is first reached (up to 1 hour)
Surgeon and anesthesiologist satisfaction
Satisfaction rated by the surgeon and by the anesthesiologist on a 5-point Likert scale (from very satisfied to very dissatisfied).
Time frame: Immediately after the end of skin closure
Recovery time
Time from discontinuation of the sedative to a modified Aldrete score ≥ 9 (or return to baseline neurological status in patients with hemiparesis), in minutes.
Time frame: From end of surgery until recovery, assessed up to 2 hours
Incidence of respiratory adverse events
Number of patients with apnea (\> 20 s), hypoventilation (respiratory rate \< 8/min or loss of the capnography waveform), desaturation (SpO2 \< 92% for ≥ 30 s), upper airway obstruction or need for ventilatory assistance.
Time frame: From start of sedation until discharge from the post-anesthesia care unit (up to 4 hours)
Incidence of hemodynamic adverse events
Number of patients with bradycardia (heart rate \< 50 bpm), hypotension (mean arterial pressure \< 65 mmHg or decrease \> 25% from baseline) or hypertension (systolic pressure \> 160 mmHg or increase \> 20% from baseline), and need for corrective treatment.
Time frame: From start of sedation until end of surgery (approximately 1 hour)
Sedation failure rate
Proportion of patients with efficacy failure (dose ceiling with RASS \> -2, persistent agitation, non-protocol rescue sedative) or procedural failure (conversion to general anesthesia, persistent desaturation, major hemodynamic instability).
Time frame: Intraoperative (approximately 1 hour)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared publicly; anonymized data may be made available upon reasonable request to the principal investigator.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
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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 ↗
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Studies of the drug tested here: Dexmedetomidine
National Institute of Neurology, Tunisia