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.
調査の概要
詳細な説明
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%.
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Rabeb Hammami, Assistant Professor
- 電話番号：+216 56442412
- メール：hammamirabeb2@gmail.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
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|
アクティブコンパレータ：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of time within target sedation
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to target sedation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- INNMBHN-16/2026
- approval number 16/2026 (その他の識別子：Ethics Committee of Institut National Mongi Ben Hmida de Neurologie, approval number 16/2026)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Individual participant data will not be shared publicly; anonymized data may be made available upon reasonable request to the principal investigator.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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