The Effect of Anaesthetic Technique and How Anaesthesia is Titrated on the Postoperative Cognitive Performance and General Recovery Following Hand and Upper Extremity Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Participants With Cognitive Recovery at 48 Hours
研究概览
简要总结
The goal of this randomized clinical trial is to determine whether Bispectral Index (BIS)-guided general anesthesia improves postoperative cognitive recovery and overall quality of recovery in adults undergoing elective hand or arm surgery.
The main questions it aims to answer are:
Does BIS-guided anesthesia improve postoperative cognitive recovery compared with general anesthesia guided by routine clinical signs?
Does BIS-guided anesthesia improve overall postoperative recovery, as measured by the Postoperative Quality of Recovery Scale (PQRS)?
Researchers will compare patients receiving BIS-guided general anesthesia with patients receiving clinically guided general anesthesia, in which the BIS monitor records data but the displayed values are concealed from the anesthesia team, to determine whether BIS-guided anesthetic management improves postoperative recovery. An additional comparison group will consist of patients undergoing surgery under intravenous regional anesthesia without general anesthesia.
Participants will:
undergo elective hand or arm surgery; receive either BIS-guided or clinically guided general anesthesia, or intravenous regional anesthesia without general anesthesia; complete PQRS assessments before surgery and at multiple postoperative time points, including follow-up for up to three months.
详细描述
The study was designed to investigate the relationship between anesthetic technique, depth of general anesthesia, and postoperative cognitive and overall recovery following elective surgery of the hand or arm.Patients scheduled to receive general anesthesia were randomly allocated using sealed envelopes to one of two general-anesthesia groups. In the BIS-guided group, anesthetic delivery was adjusted using the Bispectral Index, with a target BIS range of 40 to 60. In the clinically guided group, anesthesia was adjusted according to routine clinical indicators, such as blood pressure, heart rate, movement, and other clinical signs. BIS monitoring was also connected in this group, but the values were concealed from the anesthesia personnel and stored for later analysis.General anesthesia was induced with propofol and maintained using sevoiurane and remifentanil according to the study protocol and routine clinical practice. Standard intraoperative monitoring included electrocardiography, noninvasive blood-pressure measurement, oxygen saturation, temperature, and BIS monitoring. Perioperative fluids, treatment of blood-pressure changes, analgesia, and prevention or treatment of postoperative nausea were managed according to the study protocol and usual clinical routines.A separate comparison group consisted of patients whose planned operation was performed using intravenous regional/local anesthesia without general anesthesia. These patients were not randomly assigned to the regional-anesthesia group; their anesthetic method had already been selected as part of their clinical surgical plan.Postoperative recovery was evaluated using the Postoperative Quality of Recovery Scale.
Each participant completed a preoperative baseline assessment, and postoperative assessments were planned at approximately 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery. The scale assessed physiological recovery, pain and postoperative nausea or vomiting, emotional recovery, cognitive performance, activities of daily living, and overall patient-reported recovery.Cognitive assessments included orientation, forward digit recall, backward digit recall, word recall, and word generation.
Postoperative performance was compared with each participant's own preoperative baseline rather than with a single population-level cutoff.The prospect primary assessment was cognitive recovery at 48 hours after surgery. Additional assessments examined recovery at the other postoperative time points, anesthetic exposure, recorded BIS values, perioperative physiological variables, and early postoperative recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
In the clinically guided general-anesthesia group, BIS values were recorded but concealed from the anesthesia personnel. In the BISguided group, the anesthesia personnel could see the BIS values and use them to guide anesthetic delivery. The anesthesia care provider was therefore aware of the assigned management strategy. Participants were under general anesthesia during the intervention. The available protocol documents do not clearly establish whether investigators or postoperative PQRS outcome assessors remained unaware of treatment allocation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older.
- •Scheduled to undergo hand or arm surgery using either intravenous regional anesthesia or general anesthesia.
- •Able to understand the study information and provide informed consent.
- •Able to complete the Postoperative Quality of Recovery Scale assessments and cognitive tests.
排除标准
- •Inability to complete the recovery or cognitive assessments.
- •Deafness or hearing impairment that prevented completion of the assessments.
- •Bispectral Index monitoring could not be applied or used because of technical or surgical reasons.
- •Expected duration of surgery of less than 30 minutes or more than 4 hours.
- •Allergy to nuts or soybeans in participants scheduled to receive general anesthesia.
- •Pregnancy.
- •Substance abuse.
结局指标
主要结局
Participants With Cognitive Recovery at 48 Hours
时间窗: 48 hours after surgery
Cognitive recovery was assessed using the cognitive domain of the Postoperative Quality of Recovery Scale (PQRS). The domain included orientation, forward digit recall, backward digit recall, word recall, and word generation. Each participant's postoperative performance was compared with that participant's preoperative baseline using the PQRS recovery criteria. A participant was classiMed as cognitively recovered when all applicable cognitive subtests met the recovery criteria. The outcome was reported as the number and percentage of participants cognitively recovered
次要结局
- Participants With Cognitive Recovery at Other Postoperative Time Points(20 minutes, 40 minutes, 24 hours, 14 days, and 90 days after surgery)
- Participants With Overall Postoperative Quality of Recovery(20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery)
- Meeting PQRS Physiological Recovery Criteria(Immediately after emergence and at 20 and 40 minutes after surgery)
- Postoperative Pain Severity Assessed With PQRS(Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery)
- Participants Meeting PQRS Emotional Rcovery Criteria(Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery)
- Postoperative nausea and vomiting(Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery)
- Participants Meeting PQRS Activities of Daily Living Recovery Criteria(Baseline and 20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery)
- Patient-Reported Overall Recovery and Satisfaction Assessed With PQRS(20 minutes, 40 minutes, 24 hours, 48 hours, 14 days, and 90 days after surgery)