Efficacy of BIS Monitoring in Deep Hypnotic State and Its Outcome on Patient Undergoing Elective Neurosurgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Deep Hypnotic State
研究概览
简要总结
Determining the efficacy of the BIS monitor in monitoring deep hypnotic states as well as intra- and post-operative outcomes in neurosurgery patients
详细描述
This study will be conducted with a two-group, double-blind, randomized clinical trial design in elective patients who will undergo neurosurgical procedures under general anesthesia. Patients scheduled for elective neurosurgery who meet the inclusion criteria will be randomized into one of the intervention groups, with or without BIS. Demographic data will be taken from medical records. In both groups, the BIS probe will be inserted before induction, but for the control group, the BIS monitor will be closed, while for the intervention group, anesthesia will be titrated according to the BIS value to maintain the BIS value in the range of 40-60. In the group with an open BIS, the anesthesia protocol is the use of anesthetic gas, and the anesthetic drug will be adjusted to the BIS value range of 40-60 or BIS-guided, while the anesthesia protocol used in a closed BIS is carried out like general anesthesia without using BIS. The BIS value will be recorded minute by minute according to the extraction feature of the BIS machine after surgery. The total use of anesthetic agents, duration of surgery, and intraoperative hemodynamics will be recorded through anesthesia status. The patient will follow the progress until the patient is discharged from the hospital
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
- Double (Participant, Care Provider)
盲法说明
The anesthesia protocol used in closed BIS is carried out like general anesthesia without using BIS.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 30-60 years with an ASA tolerance of 1-2 who will undergo general anesthesia techniques
- •Operation duration > 3 hours
- •The patient agrees to take part in the study.
排除标准
- •Continuous intraoperative use of ketamine, magnesium sulfate, dexmedetomidine, lidocaine agents
- •Massive bleeding that causes hemodynamic disturbances
- •Severe electrolyte disturbances
- •Severe liver or kidney function disorders
- •The patient was decided not to extubate in the operating room
结局指标
主要结局
Deep Hypnotic State
时间窗: During surgery and up to 24 hours after surgery
the state of depth of anesthesia where the Bispectral Index value is \<40. is calculated from the beginning of induction to the end of the operation and accumulated at the end of the operation.
Vasopressor use
时间窗: Before surgery, during surgery, up to 24 hours after surgery
Use of vasopressor agents (dopamine, dobutamine, norepinephrine, epinephrine, etc.) will be calculated and totaled at the end of surgery.
Lenght of stay
时间窗: From the date of randomization until 28 days after surgery
The length of stay is measured from days after surgery until being discharged from the hospital.
Total use of anesthetic agents
时间窗: During surgery and up to 24 hours after surgery
The amount of anesthetic gas used from the start of the operation to the end of the operation
Incidence of delirium
时间窗: up to 24 hour after surgery
The method for measuring the incidence of delirium will be assessed by researchers using the CAM (Confusion Assessment Method) questionnaire which has been validated in Indonesian
Incidence of mortality
时间窗: up to 28 days after surgery
The incidence of death after surgery in hospital or outside the hospital
Duration of recovery
时间窗: up to 7 days post operative
The duration of recovery was measured from post-operative day 0 until the patient was able to return to the patient's baseline function
Number of Participants with Hypotension and Bradycardia Intraoperative
时间窗: During surgery and up to 24 hours after surgery
Intraoperative hypotension was defined as systolic blood pressure \<90 mm Hg for \>5 minutes or a 35% decrease in MAP. Intraoperative bradycardia was defined as a heart rate \<60 beats/min for \>5 minutes
次要结局
未报告次要终点
研究者
Bintang Pramodana
Principal Investigator
Indonesia University