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

NCT06275542 | Enrolling By Invitation

• 1 other identifier: USurabaya
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Intubation Complication

Keywords

Extubation; residual paralysis; Quantitative TOF monitoring; reversal

Outcome Measures

Primary Outcomes (1)

• Residual paralysis in recovery 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.

  Up to 30 minutes in recovering room

Secondary Outcomes (1)

• Adverse events

  Up to 30 minutes in recovering room

Study Arms (2)

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.

Drug: Neostigmine; Procedure: Air chalenge prior to extubation; Device: Train of Four monitoring device in recovery room

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.

Device: Train of four monitoring device intraoperative; Drug: Neostigmine; Procedure: Air chalenge prior to extubation; Device: Train of Four monitoring device in recovery room

Interventions

Train of four monitoring device intraoperative 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.

Clinical extubation strategy with TOF monitoring

Neostigmine 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.

Also known as: Neuromuscular blockade reversal

Clinical extubation strategy with TOF monitoring; Clinical extubation strategy without TOF monitoring

Air chalenge prior to extubation 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.

Clinical extubation strategy with TOF monitoring; Clinical extubation strategy without TOF monitoring

Train of Four monitoring device in recovery room 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; Clinical extubation strategy without TOF monitoring

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Surabaya: lead
• Anesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Gadjah Mada: collaborator

Study Sites (1)

Sardjito General Hospital

Yogyakarta, 55284, Indonesia

Location

MeSH Terms

Interventions

Neostigmine

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ardyan Prima Wardhana, MD

Model Details: The study was conducted through a randomized clinical trial with blinding of observers. Two parallel groups were selected to compare the incidence of paralysis in the recovery room. The research samples were collected using non-probability sampling method through consecutive enrollment over a specific period. This study consisted of 3 comparisons distinguished based on the type of volatile anesthetic gas maintenance and neuromuscular blockade agent, namely: * Comparison 1: The volatile anesthetic gas used was sevoflurane and the muscular blockade agent used was rocuronium. * Comparison 2: The volatile anesthetic gas used was isoflurane and the muscular blockade agent used was rocuronium. * Comparison 3: The volatile anesthetic gas used was sevoflurane and the muscular blockade agent used was atracurium.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 23, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

ID (1)