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

Not Applicable

• Conditions: Anesthesia Intubation Complication
• Interventions: Device: Train of four monitoring device intraoperative; Drug: Neostigmine; Procedure: Air chalenge prior to extubation; Device: Train of Four monitoring device in recovery room

• Registration Number: NCT06275542
• Lead Sponsor: University of Surabaya

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-23
• Study Start: 2024-04-01
• Primary Completion: 2024-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Elective surgery
2. Adult patiens aged 18-60 years
3. ASA physical status I-II
4. Not receiving oxygen supplementation during pre-operative care

Exclusion Criteria

1. History of hypersensitivy or allergy to neostigmine, muscular blockade agents, or anesthetic agents given
2. Head or neck surgery
3. Inability to access the ulnar nerve for TOF measurement device placement
4. History of lung diseases such asthma, COPD, or pleural effusion
5. Hepatic impairment with liver enzyme values > 50% of the normal range
6. Renal insufficiency (serum creatinine > 1.8 mg/dl) or kidney failure
7. Patients with neuromuscular diseases
8. Body mass index (BMI) > 35 kg/m2
9. 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.
10. Patients with contraindications to neostigmine or atropine sulfate
11. Planned post-operative intensive care unit treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical extubation strategy without TOF monitoring	Air chalenge prior to extubation	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.
Clinical extubation strategy without TOF monitoring	Train of Four monitoring device in recovery room	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.
Clinical extubation strategy with TOF monitoring	Train of four monitoring device intraoperative	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.
Clinical extubation strategy without TOF monitoring	Neostigmine	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.
Clinical extubation strategy with TOF monitoring	Air chalenge prior to extubation	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.
Clinical extubation strategy with TOF monitoring	Train of Four monitoring device in recovery room	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.
Clinical extubation strategy with TOF monitoring	Neostigmine	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.

Primary Outcome Measures

Name	Time	Method
Residual paralysis in recovery room	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.

Secondary Outcome Measures

Name	Time	Method
Adverse events	Up to 30 minutes in recovering room	Any adverse respiratory events such as upper airway obstruction, hypoxemia, respiratory distress, and reintubation; Severe allergic reaction

Trial Locations

Locations (1)

Sardjito General Hospital; 🇮🇩 Yogyakarta, Indonesia