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Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia

27 octobre 2026 mis à jour par: Hammami Rabeb, National Institute of Neurology, Tunisia

Propofol Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery: A Prospective Randomized Controlled Trial

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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%.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Age 18 years or older
  • Confirmed diagnosis of unilateral chronic subdural hematoma scheduled for burr-hole surgery under local anesthesia with sedation
  • Glasgow Coma Scale score ≥ 13
  • Baseline Richmond Agitation-Sedation Scale score of 0 or -1 before any sedation
  • ASA physical status I to III
  • Written informed consent signed by the patient

Exclusion Criteria:

  • Refusal to participate
  • Allergy or contraindication to propofol or dexmedetomidine
  • Major cognitive impairment preventing understanding of instructions
  • Receptive aphasia preventing RASS assessment
  • Baseline heart rate < 50 beats per minute
  • Second- or third-degree atrioventricular block without a pacemaker
  • ASA III with decompensated respiratory disease (COPD on long-term oxygen therapy, severe asthma)
  • Body mass index > 35 kg/m²
  • Inability to understand the language without an available interpreter
  • Participation in another clinical trial

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: dexmedetomidine

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.
Médicament: Dexmedetomidine

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.

Autres noms:
  • Précédent
Comparateur actif: propofol

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.
Médicament: Propofol (Astra-Zeneca)

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.

Autres noms:
  • diprivan

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of time within target sedation
Délai: Intraoperative, from skin incision to end of skin closure (approximately 1 hour)

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.
Intraoperative, from skin incision to end of skin closure (approximately 1 hour)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time to target sedation
Délai: From start of sedation until target sedation is first reached (up to 1 hour)

Time from the start of the sedative to the first RASS score between -2 and -3, in minutes.
From start of sedation until target sedation is first reached (up to 1 hour)
Surgeon and anesthesiologist satisfaction
Délai: Immediately after the end of skin closure

Satisfaction rated by the surgeon and by the anesthesiologist on a 5-point Likert scale (from very satisfied to very dissatisfied).
Immediately after the end of skin closure
Recovery time
Délai: From end of surgery until recovery, assessed up to 2 hours

Time from discontinuation of the sedative to a modified Aldrete score ≥ 9 (or return to baseline neurological status in patients with hemiparesis), in minutes.
From end of surgery until recovery, assessed up to 2 hours
Incidence of respiratory adverse events
Délai: From start of sedation until discharge from the post-anesthesia care unit (up to 4 hours)

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.
From start of sedation until discharge from the post-anesthesia care unit (up to 4 hours)
Incidence of hemodynamic adverse events
Délai: From start of sedation until end of surgery (approximately 1 hour)

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.
From start of sedation until end of surgery (approximately 1 hour)
Sedation failure rate
Délai: Intraoperative (approximately 1 hour)

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).
Intraoperative (approximately 1 hour)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Institute of Neurology, Tunisia

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

30 avril 2027

Achèvement de l'étude (Estimé)

30 avril 2027

Dates d'inscription aux études

Première soumission

27 octobre 2026

Première soumission répondant aux critères de contrôle qualité

27 octobre 2026

Première publication (Réel)

3 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • INNMBHN-16/2026
  • approval number 16/2026 (Autre identifiant: Ethics Committee of Institut National Mongi Ben Hmida de Neurologie, approval number 16/2026)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared publicly; anonymized data may be made available upon reasonable request to the principal investigator.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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