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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Rabeb Hammami, Assistant Professor
- Número de telefone: +216 56442412
- E-mail: hammamirabeb2@gmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
Outros nomes:
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of time within target sedation
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to target sedation
Prazo: 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
Prazo: 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
Prazo: 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
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Incidence of respiratory adverse events
Prazo: 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
Prazo: 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
Prazo: 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)
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Distúrbios Cerebrovasculares
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Vasculares
- Doenças cardiovasculares
- Ferimentos e Lesões
- Processos Patológicos
- Doença crônica
- Atributos da doença
- Hemorragia
- Trauma Craniocerebral
- Trauma, Sistema Nervoso
- Hemorragias Intracranianas
- Hemorragia Intracraniana Traumática
- Condições Patológicas, Sinais e Sintomas
- Hematoma Subdural
- Hematoma
- Hematoma Subdural Crônico
- Produtos químicos orgânicos
- Compostos heterocíclicos, 1 anel
- Compostos heterocíclicos
- Azoles
- Hidrocarbonetos
- Hidrocarbonetos, cíclicos
- Hidrocarbonetos, aromáticos
- Imidazoles
- Fenóis
- Derivados de benzeno
- Dexmedetomidina
- Propofol
Outros números de identificação do estudo
- INNMBHN-16/2026
- approval number 16/2026 (Outro identificador: Ethics Committee of Institut National Mongi Ben Hmida de Neurologie, approval number 16/2026)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data will not be shared publicly; anonymized data may be made available upon reasonable request to the principal investigator.
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