Neuromuscular Blocking AgentsPhase 1/2NCT06794450
Recovery Times of Half Dose Sugammadex and Neostigmine for Rocuronium-induced Neuromuscular Blockade
A Phase 1/2 study testing Sugammadex 1 mg/kg and Neostigmine + Atropine in people with Neuromuscular Blocking Agents and Reversal of Neuromuscular Blockade, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
In operating procedure with general anesthesia muscle relaxant is usually used to increase success rate of the operation and to give better outcome. The use of reversal drugs aims to reduce the risk of post-operative complications due to muscle relaxants. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Neuromuscular Blocking Agents, Reversal of Neuromuscular Blockade, Recovery Time
- What is being tested?
- Sugammadex 1 mg/kg and Neostigmine + Atropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Nov 2024to Feb 2025
- Phase
- Phase 1/2
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who underwent laparoscopic cholecystectomy under general anesthesia
- Using muscle relaxant rocuronium
- Aged 18-59 years
- American Society of Anesthesiologists (ASA) physical status classification of 1 or 2.
Who cannot join
- History of drug allergies to the agents used
- Renal dysfunction
- Musculoskeletal disorders
- Central nervous system disorders
- Difficult airways requiring intubation without the use of muscle relaxants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Hasan Sadikin General Hospital
Bandung, West Java, 40161
About this study
Official title: Comparison of Recovery Times Between 1 mg/kg Sugammadex and 60 mcg/kg Neostigmine for Moderate Neuromuscular Blockade Induced by Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
In operating procedure with general anesthesia muscle relaxant is usually used to increase success rate of the operation and to give better outcome. The use of reversal drugs aims to reduce the risk of post-operative complications due to muscle relaxants. Neostigmine is commonly used as a reversal drug, but its indirect mechanism of action results in a long and unpredictable recovery time. Sugammadex directly bind and inactivate rocuronium, in which resulting in a faster and predictable recovery time. However, the high price limits the use of sugammadex.
This study aims to compare the effect of half dose sugammadex and neostigmine against the moderate neuromuscular blockade of rocuronium.
Read more
The main questions it aims to answer are:
Does half dose sugammadex gives faster recovery time? Researchers will compare sugammadex to neostigmine to see if sugammadex gives faster recovery time.
Participants will:
Be given sugammadex or neostigmine as a reversal drug after the operation done
Read the detailed description
Neuromuscular blocking agents are frequently utilized to facilitate tracheal intubation, minimize the risk of vocal cord injury, suppress patient movement, and ensure optimal ventilation. The administration of these agents, along with meticulous monitoring of neuromuscular blockade depth, plays a critical role in optimizing the success rates and minimizing complications associated with various surgical procedures, including laparotomy and laparoscopic abdominal surgeries.
At the conclusion of surgery, when muscle relaxation is no longer required, neuromuscular blockade should be reversed promptly, safely, and reliably using appropriate reversal agents to minimize the risk of postoperative complications associated with residual neuromuscular blockade. A study reported that 64% of patients undergoing general anesthesia exhibited a neuromuscular recovery of less than 90% and experienced symptoms of re-curarization in the recovery room.
Various reversal agents are available to counteract the effects of neuromuscular blockade, utilizing either direct or indirect mechanisms of action. Cholinesterase inhibitors, such as neostigmine, are among the most commonly used agents. They act indirectly by inhibiting acetylcholinesterase, thereby preventing the breakdown of acetylcholine at the neuromuscular junction. However, this mechanism is reliant on the individual's acetylcholine production rate, which can limit neostigmine's effectiveness, contributing to its unpredictability, and increase the risk of re-curarization. In contrast, sugammadex is a specialized reversal agent designed specifically to counteract neuromuscular blockade induced by rocuronium. Unlike neostigmine, sugammadex employs a direct mechanism by encapsulating rocuronium molecules and forming an inactive complex. This approach enables a faster onset of action and provides a more consistent and predictable recovery profile.
The utilization of sugammadex in Indonesia remains relatively limited, despite the frequent use of rocuronium as a muscle relaxant. This limited use is largely attributed to the significantly higher cost of sugammadex compared to neostigmine. Nonetheless, research has demonstrated that even at doses lower than the recommended levels, sugammadex achieves faster recovery times compared to neostigmine in reversing neuromuscular blockade induced by rocuronium. This trial looks forward to answering the recovery time of half-dose recommended sugammadex compared with neostigmine with usual dose.
- Being tested
- Sugammadex 1 mg/kg, Neostigmine + Atropine
- Keywords
- Sugammadex, Neostigmine, recovery time from neuromuscular blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex 1 mg/kgDrug
Patient in experimental arms will receive i.v. sugammadex 1 mg/kg at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed
Neostigmine + AtropineDrug
Patient in active comparators arms will receive i.v. neostigmine 60 mcg/kg along with 0.4 mg of atropine sulfate per 1 mg of neostigmine at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Experimental | The subjects in this study were patients underwent laparoscopic cholecystectomy surgery with general anesthesia and muscle relaxant Rocuronium.
At the end of the surgery, thirty patients will be administered Sugammadex 1 mg/kg as a reversal agent. All patient will receive same anesthetic drug. Patients will be monitored with acceleromyography monitoring tools. Extubation was performed when the Train of Four monitor reached a Train of Four Ratio ≥ 90%. Receives: Drug: Sugammadex 1 mg/kg |
| Neostigmine | Active comparator | The subjects in this study were patients underwent laparoscopic cholecystectomy surgery with general anesthesia and muscle relaxant rocuronium.
At the end of the surgery, thirty patients will be administered Neostigmine 60 mcg/kg along with 0.4 mg of atropine sulfate per 1 mg of neostigmine as a reversal agent. All patient will receive same anesthetic drug. Patients will be monitored with acceleromyography monitoring tools. Extubation was performed when the Train of Four monitor reached a Train of Four Ratio ≥ 90%. Receives: Drug: Neostigmine + Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
This refers to the duration measured from the point at which a Train-of-Four Count (TOFC) of 2 is observed, indicating the administration of the reversal agent, to the achievement of a Train-of-Four Ratio (TOFR) of 90%.
Train of four is a electrical stimulus pattern that describe the neuromuscular blockade depth. Acceleromyography device used to monitor the neuromuscular blockade depth. Train of Four count (TOFC) 1-3 counted as moderate neuromuscular blockade, train of count (TOFC) 0 counted as deep neuromuscular blockade, train of four count (TOFC) 4 until train of four ratio (TOFR) 89% counted as mild or minimal neuromuscular blockade, and train of four ratio (TOFR) 90% counted as adequate recovery
Measured: 1 hour
Secondary outcomes (3)
Spontaneous recovery time of rocuronium
This refers to the duration measured from the administration of rocuronium to the achievement of a Train-of-Four Count (TOFC) of 1 and 2
After administration of rocuronium, subject will undergo deep neuromuscular blockade with train of four count 0. Rocuronium will undergo spontaneous degradation over a certain period, but it depends on the body's response to diffusion, redistribution, metabolism, excretion, and release from the muscle relaxant receptors. The duration from the administration of rocuronium, which causes deep neuromuscular blockade with a TOFC depth of 0, to the achievement of moderate neuromuscular blockade with TOFC depths of 1 and 2 will be measured.
Measured: 3 hours
Bradycardia
Assess the frequency of bradicardia after the reversal agent administered
Measured: 1 hour
Hypotension
Assess the frequency of hypotension (mean arterial pressure under 65) after the administration of reversal agent
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start5 Nov 2024
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular Blocking AgentsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tini T Maskoen, M.D., Study chair, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794450
- Sponsor's protocol ID
- AN-202412.01
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Recovery Times Between 1 mg/kg Sugammadex and 60 mcg/kg Neostigmine for Moderate Neuromuscular Blockade Induced by Rocuronium in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06794450
- Acronym / sponsor ID
- AN-202412.01
- Keywords
- Sugammadex, Neostigmine, recovery time from neuromuscular blockade
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 27 Jan 2025 (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.
In operating procedure with general anesthesia muscle relaxant is usually used to increase success rate of the operation and to give better outcome. The use of reversal drugs aims to reduce the risk of post-operative complications due to muscle relaxants. Neostigmine is commonly used as a reversal drug, but its indirect mechanism of action results in a long and unpredictable recovery time. Sugammadex directly bind and inactivate rocuronium, in which resulting in a faster and predictable recovery time. However, the high price limits the use of sugammadex.
This study aims to compare the effect of half dose sugammadex and neostigmine against the moderate neuromuscular blockade of rocuronium.
The main questions it aims to answer are:
Does half dose sugammadex gives faster recovery time? Researchers will compare sugammadex to neostigmine to see if sugammadex gives faster recovery time.
Participants will:
Be given sugammadex or neostigmine as a reversal drug after the operation done
Detailed description
Neuromuscular blocking agents are frequently utilized to facilitate tracheal intubation, minimize the risk of vocal cord injury, suppress patient movement, and ensure optimal ventilation. The administration of these agents, along with meticulous monitoring of neuromuscular blockade depth, plays a critical role in optimizing the success rates and minimizing complications associated with various surgical procedures, including laparotomy and laparoscopic abdominal surgeries.
At the conclusion of surgery, when muscle relaxation is no longer required, neuromuscular blockade should be reversed promptly, safely, and reliably using appropriate reversal agents to minimize the risk of postoperative complications associated with residual neuromuscular blockade. A study reported that 64% of patients undergoing general anesthesia exhibited a neuromuscular recovery of less than 90% and experienced symptoms of re-curarization in the recovery room.
Various reversal agents are available to counteract the effects of neuromuscular blockade, utilizing either direct or indirect mechanisms of action. Cholinesterase inhibitors, such as neostigmine, are among the most commonly used agents. They act indirectly by inhibiting acetylcholinesterase, thereby preventing the breakdown of acetylcholine at the neuromuscular junction. However, this mechanism is reliant on the individual's acetylcholine production rate, which can limit neostigmine's effectiveness, contributing to its unpredictability, and increase the risk of re-curarization. In contrast, sugammadex is a specialized reversal agent designed specifically to counteract neuromuscular blockade induced by rocuronium. Unlike neostigmine, sugammadex employs a direct mechanism by encapsulating rocuronium molecules and forming an inactive complex. This approach enables a faster onset of action and provides a more consistent and predictable recovery profile.
The utilization of sugammadex in Indonesia remains relatively limited, despite the frequent use of rocuronium as a muscle relaxant. This limited use is largely attributed to the significantly higher cost of sugammadex compared to neostigmine. Nonetheless, research has demonstrated that even at doses lower than the recommended levels, sugammadex achieves faster recovery times compared to neostigmine in reversing neuromuscular blockade induced by rocuronium. This trial looks forward to answering the recovery time of half-dose recommended sugammadex compared with neostigmine with usual dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Experimental | Drug: Sugammadex 1 mg/kgThe subjects in this study were patients underwent laparoscopic cholecystectomy surgery with general anesthesia and muscle relaxant Rocuronium. At the end of the surgery, thirty patients will be administered Sugammadex 1 mg/kg as a reversal agent. All patient will receive same anesthetic drug. Patients will be monitored with acceleromyography monitoring tools. Extubation was performed when the Train of Four monitor reached a Train of Four Ratio ≥ 90%. |
| Neostigmine | Active comparator | Drug: Neostigmine + AtropineThe subjects in this study were patients underwent laparoscopic cholecystectomy surgery with general anesthesia and muscle relaxant rocuronium. At the end of the surgery, thirty patients will be administered Neostigmine 60 mcg/kg along with 0.4 mg of atropine sulfate per 1 mg of neostigmine as a reversal agent. All patient will receive same anesthetic drug. Patients will be monitored with acceleromyography monitoring tools. Extubation was performed when the Train of Four monitor reached a Train of Four Ratio ≥ 90%. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who underwent laparoscopic cholecystectomy under general anesthesia
- Using muscle relaxant rocuronium
- Aged 18-59 years
- American Society of Anesthesiologists (ASA) physical status classification of 1 or 2.
Key exclusion criteria (5 listed)
- History of drug allergies to the agents used
- Renal dysfunction
- Musculoskeletal disorders
- Central nervous system disorders
- Difficult airways requiring intubation without the use of muscle relaxants.
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 |
|---|---|---|
| Sugammadex 1 mg/kgPatient in experimental arms will receive i.v. sugammadex 1 mg/kg at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed | Drug | Sugammadex |
| Neostigmine + AtropinePatient in active comparators arms will receive i.v. neostigmine 60 mcg/kg along with 0.4 mg of atropine sulfate per 1 mg of neostigmine at the end of operating procedure from the point at which a Train-of-Four Count (TOFC) of 2 is observed | Drug | Neostigmine |
Primary outcome
Recovery time
Time frame: 1 hour
This refers to the duration measured from the point at which a Train-of-Four Count (TOFC) of 2 is observed, indicating the administration of the reversal agent, to the achievement of a Train-of-Four Ratio (TOFR) of 90%. Train of four is a electrical stimulus pattern that describe the neuromuscular blockade depth. Acceleromyography device used to monitor the neuromuscular blockade depth. Train of Four count (TOFC) 1-3 counted as moderate neuromuscular blockade, train of count (TOFC) 0 counted as deep neuromuscular blockade, train of four count (TOFC) 4 until train of four ratio (TOFR) 89% counted as mild or minimal neuromuscular blockade, and train of four ratio (TOFR) 90% counted as adequate recovery
3 secondary outcomes
Spontaneous recovery time of rocuronium
Time frame: 3 hours
Bradycardia
Time frame: 1 hour
Hypotension
Time frame: 1 hour
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 28 Jan 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.
Tini T Maskoen, M.D. study chair
Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sugammadex 1 mg/kg and Neostigmine + Atropine in people with Neuromuscular Blocking Agents and Reversal of Neuromuscular Blockade, run by Universitas Padjadjaran 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 5 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: looking for participants now, as of the sponsor's last update on 28 Jan 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Rivan P Rivan Putra Afewa, M.D., M.D. (+6285316832464, rivan.chaniago@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time (time frame: 1 hour). 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 28 Jan 2025.