Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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%.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rabeb Hammami, Assistant Professor
- Número de teléfono: +216 56442412
- Correo electrónico: hammamirabeb2@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
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.
Otros nombres:
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Comparador activo: 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. |
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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of time within target sedation
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time to target sedation
Periodo de tiempo: 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
Periodo de tiempo: 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
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Recovery time
Periodo de tiempo: From end of surgery until recovery, assessed up to 2 hours
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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
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Incidence of respiratory adverse events
Periodo de tiempo: 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)
|
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Incidence of hemodynamic adverse events
Periodo de tiempo: 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)
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Sedation failure rate
Periodo de tiempo: Intraoperative (approximately 1 hour)
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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)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Heridas y Lesiones
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Hemorragia
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Hemorragias intracraneales
- Hemorragia Intracraneal Traumática
- Condiciones Patológicas, Signos y Síntomas
- Hematoma Subdural
- Hematoma
- Hematoma Subdural Crónico
- Químicos orgánicos
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Azoles
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos, aromáticos
- Imidazoles
- Fenoles
- Derivados de benceno
- Dexmedetomidina
- Propofol
Otros números de identificación del estudio
- INNMBHN-16/2026
- approval number 16/2026 (Otro identificador: Ethics Committee of Institut National Mongi Ben Hmida de Neurologie, approval number 16/2026)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Individual participant data will not be shared publicly; anonymized data may be made available upon reasonable request to the principal investigator.
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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