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

NCT ID: NCT06275542

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-01-01

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.

Conditions

Anesthesia Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Clinical extubation strategy without TOF monitoring

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.

Group Type: EXPERIMENTAL

Neostigmine

Intervention Type: DRUG

For subjects in Group A, the first researcher calculated the time of the last administration of the muscle relaxant and the subject's spontaneous breathing efforts. Neostigmine was administered based on the reversal protocol. For subjects in the TOF monitoring group (Group B), the first researcher attached the TOF monitoring device. After it was attached and turned on, TOF stimulation was provided without calibration, with a stimulation intensity of 50 mA. Measurements were taken in a 12-second cycle mode. Neostigmine was administered according to the measured TOF value at the start of skin/muscle closure as the protocol.

Air chalenge prior to extubation

Intervention Type: PROCEDURE

After surgery was completed and the TOF ratio was ≥ 0.90, the TOF device was removed, and extubation was performed in Group B. In Group A, after a minimum of 15 minutes following reversal, patients received only ambient air without supplemental O2. Extubation was performed if the patient could maintain an SpO2 \> 95% for a minimum of 3 minutes. If within 15 minutes after reversal the patient did not meet the extubation criteria, the degree of blockade was reassessed, and a repeat dose of neostigmine and atropine was administered as needed. If there was suspicion of opioid-induced hypoventilation, naloxone was administered at 0.4-0.8 mcg intravenously.If the patient was unable to maintain oxygen saturation for the 3-minute duration, oxygen supplementation was reinstated, the degree of blockade was reassessed, and a repeat dose of neostigmine and atropine was administered as needed.

Train of Four monitoring device in recovery room

Intervention Type: DEVICE

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. Measurements were taken twice sequential

Clinical extubation strategy with TOF monitoring

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.

Group Type: ACTIVE_COMPARATOR

Train of four monitoring device intraoperative

Intervention Type: DEVICE

Only group B will receive reversal strategy based on the presence of TOF monitoring device prior to extubation. If they meet the criteria, patients will then be extubated.

Neostigmine

Intervention Type: DRUG

For subjects in Group A, the first researcher calculated the time of the last administration of the muscle relaxant and the subject's spontaneous breathing efforts. Neostigmine was administered based on the reversal protocol. For subjects in the TOF monitoring group (Group B), the first researcher attached the TOF monitoring device. After it was attached and turned on, TOF stimulation was provided without calibration, with a stimulation intensity of 50 mA. Measurements were taken in a 12-second cycle mode. Neostigmine was administered according to the measured TOF value at the start of skin/muscle closure as the protocol.

Air chalenge prior to extubation

Intervention Type: PROCEDURE

After surgery was completed and the TOF ratio was ≥ 0.90, the TOF device was removed, and extubation was performed in Group B. In Group A, after a minimum of 15 minutes following reversal, patients received only ambient air without supplemental O2. Extubation was performed if the patient could maintain an SpO2 \> 95% for a minimum of 3 minutes. If within 15 minutes after reversal the patient did not meet the extubation criteria, the degree of blockade was reassessed, and a repeat dose of neostigmine and atropine was administered as needed. If there was suspicion of opioid-induced hypoventilation, naloxone was administered at 0.4-0.8 mcg intravenously.If the patient was unable to maintain oxygen saturation for the 3-minute duration, oxygen supplementation was reinstated, the degree of blockade was reassessed, and a repeat dose of neostigmine and atropine was administered as needed.

Train of Four monitoring device in recovery room

Intervention Type: DEVICE

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. Measurements were taken twice sequential

Interventions

Train of four monitoring device intraoperative

Only group B will receive reversal strategy based on the presence of TOF monitoring device prior to extubation. If they meet the criteria, patients will then be extubated.

Intervention Type: DEVICE

Neostigmine

For subjects in Group A, the first researcher calculated the time of the last administration of the muscle relaxant and the subject's spontaneous breathing efforts. Neostigmine was administered based on the reversal protocol. For subjects in the TOF monitoring group (Group B), the first researcher attached the TOF monitoring device. After it was attached and turned on, TOF stimulation was provided without calibration, with a stimulation intensity of 50 mA. Measurements were taken in a 12-second cycle mode. Neostigmine was administered according to the measured TOF value at the start of skin/muscle closure as the protocol.

Intervention Type: DRUG

Air chalenge prior to extubation

After surgery was completed and the TOF ratio was ≥ 0.90, the TOF device was removed, and extubation was performed in Group B. In Group A, after a minimum of 15 minutes following reversal, patients received only ambient air without supplemental O2. Extubation was performed if the patient could maintain an SpO2 \> 95% for a minimum of 3 minutes. If within 15 minutes after reversal the patient did not meet the extubation criteria, the degree of blockade was reassessed, and a repeat dose of neostigmine and atropine was administered as needed. If there was suspicion of opioid-induced hypoventilation, naloxone was administered at 0.4-0.8 mcg intravenously.If the patient was unable to maintain oxygen saturation for the 3-minute duration, oxygen supplementation was reinstated, the degree of blockade was reassessed, and a repeat dose of neostigmine and atropine was administered as needed.

Intervention Type: PROCEDURE

Train of Four monitoring device in recovery room

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. Measurements were taken twice sequential

Intervention Type: DEVICE

Other Intervention Names

Neuromuscular blockade reversal

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Gadjah Mada

UNKNOWN

Sponsor Role: collaborator

University of Surabaya

OTHER

Sponsor Role: lead

Responsible Party

Ardyan Prima Wardhana

Ardyan Prima Wardhana, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sardjito General Hospital

Yogyakarta, , Indonesia

Countries

Indonesia

Other Identifiers

USurabaya

Identifier Type: -

Identifier Source: org_study_id