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临床试验/NCT06275542
NCT06275542Enrolling By Invitation不适用

Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criterion Without TOF Monitoring Equipment

University of Surabaya1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
240
试验地点
1
主要终点
Residual paralysis in recovery room

研究概览

简要总结

Patients undergoing general anesthesia will have an endotracheal tube inserted. Adequate muscle strength recovery in the recovery room is crucial to ensure before extubation. One of the criteria we use to determine the recovery of muscle strength post-use of muscle relaxants in conditions without specific monitoring devices is the ability to maintain body oxygen levels without oxygen assistance for 3 minutes. This study aims to determine the muscle strength value in the recovery room using extubation strategies without muscle strength monitoring compared to extubation strategies with muscle strength monitoring.

详细描述

The availability of Train-of-Four (TOF) monitoring devices is not yet widespread in some clinical practices. Practitioners are also often unaware of the high incidence of residual paralysis and the associated risks in their daily practice. However, residual paralysis increases the occurrence of airway obstruction, hypoxemia, and postoperative pulmonary complications. Therefore, clinical parameters for extubation criteria must ensure the absence of residual paralysis.

Administering oxygen in the ambient air can identify hypoventilation conditions. Therefore, patients who can maintain oxygen saturation levels > 95% can be considered not experiencing hypoventilation. The author aims to validate ventilation adequacy as an additional clinical parameter for extubation criteria without TOF monitoring to ensure the absence of residual paralysis in the recovery room.

This study is planned using a randomized controlled trial method with observer blinding. The study consists of 3 comparisons based on the type of volatile anesthetic gas agent and neuromuscular blockade agent. This research will involve 240 subjects aged 18-60 years undergoing elective surgery under intubation general anesthesia. Subjects will be divided into two parallel treatment groups randomly stratified by the type of surgery to observe the incidence rate of residual paralysis in the recovery room. Group A will receive extubation strategy without additional oxygen supplementation, while Group B will use extubation strategy with quantitative TOF monitoring.

Group A will receive optimal reversal strategy using neostigmine based on clinical criteria such as tidal volume adequacy and the time of last administration of the neuromuscular blockade agent. Then, patients will be assessed 15 minutes after reversal for the ability to maintain oxygen saturation levels > 95% without oxygen supplementation. If they meet these criteria, patients will then be extubated. Group B will receive optimal reversal strategy using neostigmine based on TOF values. If the measured TOF value is ≥0.90, patients can be extubated while awake. Upon arrival in the recovery room, the TOF values of both groups will be measured and compared as the outcome of this study.

The results of this study are expected to provide recommendations for extubation strategies based on clinical parameters to clinicians with limited access to TOF monitoring devices. With the implementation of this change in extubation strategy, unexpected post-anesthesia events may be reduced.

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
Double (Participant, Outcomes Assessor)

盲法说明

Upon arrival in the recovery room, all subjects were fitted with SpO2, EKG, NIBP monitors, and the TOF monitoring device. TOF values were measured by a second researcher who was unaware of the type of intervention.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Elective surgery
  • Adult patiens aged 18-60 years
  • ASA physical status I-II
  • Not receiving oxygen supplementation during pre-operative care

排除标准

  • History of hypersensitivy or allergy to neostigmine, muscular blockade agents, or anesthetic agents given
  • Head or neck surgery
  • Inability to access the ulnar nerve for TOF measurement device placement
  • History of lung diseases such asthma, COPD, or pleural effusion
  • Hepatic impairment with liver enzyme values > 50% of the normal range
  • Renal insufficiency (serum creatinine > 1.8 mg/dl) or kidney failure
  • Patients with neuromuscular diseases
  • Body mass index (BMI) > 35 kg/m2
  • Consumption of medications that affect neuromuscular transmission such as aminoglycoside, polymyxin, lincomycin, clindamycin, and tetracycline; local anesthetic agent, procainamide, quinidine, lithium, magnesium sulfate, furosemide, cyclosporine, dantrolene, anti-estrogens, anticonvulsant, calcium, steroid, and azathioprine.
  • Patients with contraindications to neostigmine or atropine sulfate
  • Planned post-operative intensive care unit treatment

研究组 & 干预措施

Clinical extubation strategy without TOF monitoring

Experimental

Extubation without TOF monitoring strategy: the administration of neostigmine reversal with a dose based on the degree of blockade without TOF monitoring, and extubation is performed at least 15 minutes after reversal if the patient can maintain SpO2 > 95% for 3 minutes after receiving room air without oxygen supplementation.

干预措施: Neostigmine (Drug)

Clinical extubation strategy without TOF monitoring

Experimental

Extubation without TOF monitoring strategy: the administration of neostigmine reversal with a dose based on the degree of blockade without TOF monitoring, and extubation is performed at least 15 minutes after reversal if the patient can maintain SpO2 > 95% for 3 minutes after receiving room air without oxygen supplementation.

干预措施: Air chalenge prior to extubation (Procedure)

Clinical extubation strategy without TOF monitoring

Experimental

Extubation without TOF monitoring strategy: the administration of neostigmine reversal with a dose based on the degree of blockade without TOF monitoring, and extubation is performed at least 15 minutes after reversal if the patient can maintain SpO2 > 95% for 3 minutes after receiving room air without oxygen supplementation.

干预措施: Train of Four monitoring device in recovery room (Device)

Clinical extubation strategy with TOF monitoring

Active Comparator

Extubation with quantitative TOF monitoring strategy: neostigmine reversal dosing is determined based on the degree of blockade observed through quantitative TOF monitoring, and extubation is performed when the measured TOF ratio is ≥ 0.90.

干预措施: Train of four monitoring device intraoperative (Device)

Clinical extubation strategy with TOF monitoring

Active Comparator

Extubation with quantitative TOF monitoring strategy: neostigmine reversal dosing is determined based on the degree of blockade observed through quantitative TOF monitoring, and extubation is performed when the measured TOF ratio is ≥ 0.90.

干预措施: Neostigmine (Drug)

Clinical extubation strategy with TOF monitoring

Active Comparator

Extubation with quantitative TOF monitoring strategy: neostigmine reversal dosing is determined based on the degree of blockade observed through quantitative TOF monitoring, and extubation is performed when the measured TOF ratio is ≥ 0.90.

干预措施: Air chalenge prior to extubation (Procedure)

Clinical extubation strategy with TOF monitoring

Active Comparator

Extubation with quantitative TOF monitoring strategy: neostigmine reversal dosing is determined based on the degree of blockade observed through quantitative TOF monitoring, and extubation is performed when the measured TOF ratio is ≥ 0.90.

干预措施: Train of Four monitoring device in recovery room (Device)

结局指标

主要结局

Residual paralysis in recovery room

时间窗: Up to 30 minutes in recovering room

Residual paralysis in the recovery room was defined as a condition with a measured TOF ratio \< 0.90 upon arrival in the recovery room. TOF values were measured by a second researcher who was unaware of the type of intervention. Measurements were taken twice sequentially with a 12-second interval. The value used was the average of these two measurements. However, if the values differed by \>10%, two more measurements were taken using the same method. The value used was the average of the two closest values out of the four measurements.

次要结局

  • Adverse events(Up to 30 minutes in recovering room)

研究者

发起方
University of Surabaya
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ardyan Prima Wardhana

Ardyan Prima Wardhana, MD

University of Surabaya

研究点 (1)

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