Anesthesia Intubation ComplicationNCT06275542
Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criteria Without TOF Monitoring Equipment
A study testing Train of four monitoring device intraoperative, Neostigmine and Air chalenge prior to extubation in people with Anesthesia Intubation Complication, run by University of Surabaya at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- Train of four monitoring device intraoperative, Neostigmine and Air chalenge prior to extubation
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elective surgery
- Adult patiens aged 18-60 years
- ASA physical status I-II
- Not receiving oxygen supplementation during pre-operative care
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criterion Without TOF Monitoring Equipment
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.
Read the 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
- Being tested
- Train of four monitoring device intraoperative, Neostigmine, Air chalenge prior to extubation, Train of Four monitoring device in recovery room
- Keywords
- Extubation, residual paralysis, Quantitative TOF monitoring, reversal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Train of four monitoring device intraoperativeDevice
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.
NeostigmineDrug
Also called Neuromuscular blockade reversal
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 extubationProcedure or surgery
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 roomDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Train of four monitoring device intraoperative; Drug: Neostigmine; Procedure: Air chalenge prior to extubation; Device: Train of Four monitoring device in recovery room |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 minutes in recovering room
Secondary outcomes (1)
Adverse events
Any adverse respiratory events such as upper airway obstruction, hypoxemia, respiratory distress, and reintubation; Severe allergic reaction
Measured: Up to 30 minutes in recovering room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Apr 2024
- Primary completion1 Dec 2024
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Surabaya
- Sponsor type
- University, hospital or other
- Collaborators
- Anesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Gadjah Mada
- Responsible party
- Principal investigator, Ardyan Prima Wardhana, University of Surabaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275542
- Sponsor's protocol ID
- USurabaya
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criterion Without TOF Monitoring Equipment
- ClinicalTrials.gov ID
- NCT06275542
- Acronym / sponsor ID
- USurabaya
- Conditions
- Anesthesia Intubation Complication
- Keywords
- Extubation, residual paralysis, Quantitative TOF monitoring, reversal
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of SurabayaUniversity, hospital or other
- Collaborators
- Anesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Gadjah Mada
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clinical extubation strategy without TOF monitoring | Experimental | Drug: Neostigmine, Procedure: Air chalenge prior to extubation, Device: Train of Four monitoring device in recovery roomExtubation 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 | Active comparator | Device: Train of four monitoring device intraoperative, Drug: Neostigmine, Procedure: Air chalenge prior to extubation, Device: Train of Four monitoring device in recovery roomExtubation 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Elective surgery
- Adult patiens aged 18-60 years
- ASA physical status I-II
- Not receiving oxygen supplementation during pre-operative care
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Train of four monitoring device intraoperativeOnly 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. | Device | Clinical extubation strategy with TOF monitoring |
| NeostigmineAlso: Neuromuscular blockade reversalFor 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. | Drug | Clinical extubation strategy with TOF monitoring, Clinical extubation strategy without TOF monitoring |
| Air chalenge prior to extubationAfter 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. | Procedure or surgery | Clinical extubation strategy with TOF monitoring, Clinical extubation strategy without TOF monitoring |
| Train of Four monitoring device in recovery roomUpon 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 | Device | Clinical extubation strategy with TOF monitoring, Clinical extubation strategy without TOF monitoring |
Primary outcome
Residual paralysis in recovery room
Time frame: 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.
1 secondary outcome
Adverse events
Time frame: Up to 30 minutes in recovering room
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Train of four monitoring device intraoperative, Neostigmine and Air chalenge prior to extubation in people with Anesthesia Intubation Complication, run by University of Surabaya at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual paralysis in recovery room (time frame: Up to 30 minutes in recovering room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.