Clinical trial NCT06275542: Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criteria Without TOF Monitoring Equipment
Official title: Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criterion Without TOF Monitoring Equipment
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Anesthesia Intubation Complication
Keywords: Extubation
residual paralysis
Quantitative TOF monitoring
reversal
Lead sponsor: University of Surabaya
Sponsor class: OTHER
Collaborators: name: Anesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Gadjah Mada
First posted: 2024-02-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Residual paralysis in recovery room
timeFrame: Up to 30 minutes in recovering room
Secondary outcomes:
measure: Adverse events
timeFrame: Up to 30 minutes in recovering room
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: Sardjito General Hospital
Study officials:
References: