NCT07277881尚未招募4 期
The Effect of Reversal of Remimazolam Sedation With Flumazenil on Cognitive Function in Patients Undergoing Hip Arthroplasty Under Spinal Anesthesia
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Change in Montreal Cognitive Assessment (MoCA) score
研究概览
简要总结
This clinical trial aims to establish whether reversing remimazolam sedation with flumazenil can prevent postoperative neurocognitive disorders in patients undergoing total hip replacement surgery. The main questions it aims to answer are:
- Does administering flumazenil after surgery lead to an improvement in cognitive function (measured by the MoCA scale) at 24 hours post-operation compared to a placebo?
- Does this intervention reduce the incidence of postoperative delirium within the first 48 hours? Researchers will compare flumazenil to a placebo (0.9% saline solution) to see if actively reversing sedation leads to better cognitive outcomes and a lower incidence of delirium.
Participants will:
- Undergo a planned total hip replacement surgery under spinal anesthesia.
- Receive sedation with remimazolam during the operation.
- At the end of the surgery, receive an intravenous injection of the study drug (flumazenil) or a placebo.
- Undergo assessments for cognitive function (using the MoCA scale) and delirium (using the 4AT scale) before and at multiple time points after the surgery.
- Complete a questionnaire about their quality of recovery (QoR-15).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient qualified for elective, primary, unilateral, total hip replacement.
- •Patient assessed on the ASA I-III scale.
- •MoCA score obtained during screening ≥ 23 points (to exclude patients with significant pre-existing cognitive impairment).
- •Ability to understand information about the study and express informed, written consent to participate.
排除标准
- •Known hypersensitivity or allergy to benzodiazepines, flumazenil, local anesthetics
- •Contraindications to spinal anesthesia or patient refusal of this anesthesia technique.
- •Severe liver dysfunction.
- •History of epilepsy or seizures
- •Chronic (daily use for > 2 weeks in the last 3 months) use of benzodiazepines or non-benzodiazepine hypnotics (so-called "Z" drugs: zolpidem, zopiclone, zaleplon).
- •Alcohol abuse defined as regular consumption of more than: in men: 40 g of pure ethanol at a time; in women: 20 g of pure ethanol at a time, or a history of psychoactive substance dependence.
- •Planned revision hip arthroplasty or bilateral surgery.
- •Significant neurological or psychiatric diseases that may affect the assessment of cognitive function.
- •The need for sedative premedication.
研究组 & 干预措施
Flumazenil Group
Experimental
Patients will receive a single intravenous bolus of 0.5 mg of flumazenil
干预措施: remimazolam sedation reversal with flumazenil (Drug)
Placebo Group
Placebo Comparator
Patients will receive a single intravenous bolus of 0.9% NaCl
干预措施: placebo (Drug)
结局指标
主要结局
Change in Montreal Cognitive Assessment (MoCA) score
时间窗: from baseline (preoperative) to 24 hours after surgery
The MoCA is a cognitive screening tool. The total score ranges from 0 to 30 points. A higher score indicates better cognitive function.
次要结局
- Incidence of delirium (defined as a score of ≥ 4 on the 4AT scale)(within the first 48 hours after surgery, assessed every 6 hours.)
- Total duration of delirium episodes in hours(within the first 48 hours after surgery)
- Preoperative Anxiety Level assessed by Amsterdam Preoperative Anxiety and Information Scale (APAIS)(baseline (preoperative))
- Montreal Cognitive Assessment (MoCA) score(at 1 and 6 hours after surgery)
- Mini Montreal Cognitive Assessment (mini-MoCA) scores (telephone assessment)(at 3 and 6 months after surgery)
- Quality of Recovery-15 (QoR-15) Questionnaire Score(at 24 hours after surgery)
- The duration of hospital stay(Assessed up to 30 days post-surgery (or through hospital discharge, whichever occurs first).)
- Maximum and average pain intensity measured by Numeric Rating Scale (NRS) at the following time points(6, 12, 24, and 48 hours after surgery)
- Total oxycodone consumption (in mg)(during the first 48 hours after surgery)
- Mean bispectral index (BIS) during sedation and percentage of time within the optimal range (60-80)(during surgery)
- Total dose of remimazolam administered (in mg)(during surgery)
- Dose of vasopressor drugs(during surgery)
- Need for additional sedative drugs(during surgery)
研究者
Cezary Kapłan
resident
Medical University of Gdansk
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