SugammadexNCT04997759
Comparative Efficacy and Safety of Sugammadex and Neostigmine
A study testing Neostigmine and Sugammadex in people with Sugammadex, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Along with unconsciousness and analgesia, use a muscle relaxant (Neuromuscular blocking agent NMBA) is now part of the classic triad of anesthesia. In surgery or interventional procedure under general anesthesia, NMBA is needed to relax the muscles of the whole body. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sugammadex
- What is being tested?
- Neostigmine and Sugammadex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Sep 2021to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age>20year-old
- Go Intervention or operation under general anesthesia
Who cannot join
- Chronic kidney disease(GFR<30 mL/min)
- Allergy to Sugammade/Neostigmine
- Cant extubate on the day of operation/intervention
- Neuromuscular disease
- Difficult airway
- Heart operation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Yu-Hsun-Tsai
Taoyuan, 333
YU HUSN TSAI, 886-928218752, evan468579@hotmail.com
About this study
Official title: The Comparative Efficacy and Safety of Sugammadex and Neostigmine in Reversing Neuromuscular Blockade After General Anesthesia: A Prospective Randomized Control Study
Along with unconsciousness and analgesia, use a muscle relaxant (Neuromuscular blocking agent NMBA) is now part of the classic triad of anesthesia. In surgery or interventional procedure under general anesthesia, NMBA is needed to relax the muscles of the whole body. Its purpose is to assist the placement of the endotracheal tube, avoid the participant's injury due to involuntary movements, and also enables the surgeon to have a better surgical vision, etc. Once the operation or procedure is completed, anesthesiologist will reverse the NMBA and participants are recovered from general anesthesia. It is crucial to maintain hemodynamic stability during this period. The participant's vital signs are unstable during this period because the participant is gradually recovered from anesthesia and they feel throat discomfort from endotracheal tube. Immediate extubation is encouraged in the operating theatre and full recovery of neuromuscular function must be achieved prior to extubation of the endotrachea tube.
Traditionally, acetylcholinesterase inhibitor (AChEI, such as neostigmine, pyridostigmine, edrophonium) is used to reverse the efficacy of NMBA and stabilize the participants's vital signs. However, the reversal of acetylcholine ester inhibitors is slow, the curative effect has a ceiling effect, and the need to use anticholinergics (anticholinergics) to reduce the incidence of adverse reactions and other issues. In addition, traditional muscle relaxants may also cause complications, such as postoperative residual curarization (PORC). PORC is associated with weakness of upper airway muscles and increased risk of hypoventilation and hypoxemia, as well as risk for aspiration and postoperative pulmonary complications.
Sugammadex is a new selective relaxant-binding agent that quickly and effectively reverses the effects of steroidal NMBAs, especially rocuronium and vecuronium. Compared with neostigmine, sugammadex more substantially reduces PORC, but its effects on postoperative complications require further investigation. Therefore, this study aimed to compare the effects of sugammadex and neostigmine during emergence and extubation after general anesthesia in non-cardiac surgery and interventional procedure.
Read the detailed description
Investigators will include 100 participants for both groups(Suggammadex and Neostigmine) During anesthesia induction, the same drugs will be administered intravenously (propofol, fentanyl, lidocaine and rocuronium). Rocuronium, a muscle relaxant,is part of the classic triad of anesthesia. In surgery or interventional procedure under general anesthesia, NMBA is needed to relax the muscles of the whole body. Its purpose is to assist the placement of the endotracheal tube, avoid the participants injury due to involuntary movements, and also enables the surgeon to have a better surgical vision, etc. Once the operation or procedure is completed, Investigators will reverse the NMBA and participants are recovered from general anesthesia. Group A will be administered acetylcholinesterase inhibitor (AChEI, such as neostigmine, pyridostigmine, edrophonium), AChEI is used to reverse the efficacy of NMBA and stabilize the participants's vital signs. Group B will be administered sugammadex, a new selective relaxant-binding agent that quickly and effectively reverses the effects of steroidal NMBAs. Both drug should given on the time of train of four[TOF] count 4. Investigators will collect the data include: Blood pressure(extubation, one minute, two minutes and five minutes and ten minutes after), Heart rate, Saturation, extubation time and BIS.
- Conditions
- Sugammadex
- Being tested
- Neostigmine and Sugammadex
- Keywords
- Neostigmine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neostigmine and SugammadexDrug
Compare both groups efficacy of reverse the neuromuscular blocking agent
| Study group | Role | What they receive |
|---|---|---|
| Neostigmine group | Experimental | This group will administered neostigmine for reverse the efficacy of neuromuscular blocking agent and stabilize the patient's vital signs. Receives: Drug: Neostigmine and Sugammadex |
| Sugammadex group | Experimental | This group will administered Sugammadex for reverse the efficacy of neuromuscular blocking agent and stabilize the patient's vital signs. Receives: Drug: Neostigmine and Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation time
Compare both group of extubation time and administer neostigmine or sugammadex
Measured: Since administer neostigmine or sugammadex to 30mins after Extubation
Blood pressure variability(systolic , diastolic and mean blood pressure)
Compare both group of blood pressure variability and administer neostigmine or sugammadex
Measured: Since administer neostigmine or sugammadex to 30mins after Extubation
Heart rate variability
Compare both group of heart rate variability and administer neostigmine or sugammadex
Measured: Since administer neostigmine or sugammadex to 30mins after Extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start6 Sep 2021
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SugammadexStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997759
- Sponsor's protocol ID
- 202100679A3
- Status last verified
- Jul 2021
- First submitted
- 29 Jul 2021
- Last updated
- 10 Mar 2022
- 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 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Efficacy and Safety of Sugammadex and Neostigmine in Reversing Neuromuscular Blockade After General Anesthesia: A Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT04997759
- Acronym / sponsor ID
- 202100679A3
- Conditions
- Sugammadex
- Keywords
- Neostigmine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 10 Aug 2021 (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.
Along with unconsciousness and analgesia, use a muscle relaxant (Neuromuscular blocking agent NMBA) is now part of the classic triad of anesthesia. In surgery or interventional procedure under general anesthesia, NMBA is needed to relax the muscles of the whole body. Its purpose is to assist the placement of the endotracheal tube, avoid the participant's injury due to involuntary movements, and also enables the surgeon to have a better surgical vision, etc. Once the operation or procedure is completed, anesthesiologist will reverse the NMBA and participants are recovered from general anesthesia. It is crucial to maintain hemodynamic stability during this period. The participant's vital signs are unstable during this period because the participant is gradually recovered from anesthesia and they feel throat discomfort from endotracheal tube. Immediate extubation is encouraged in the operating theatre and full recovery of neuromuscular function must be achieved prior to extubation of the endotrachea tube.
Traditionally, acetylcholinesterase inhibitor (AChEI, such as neostigmine, pyridostigmine, edrophonium) is used to reverse the efficacy of NMBA and stabilize the participants's vital signs. However, the reversal of acetylcholine ester inhibitors is slow, the curative effect has a ceiling effect, and the need to use anticholinergics (anticholinergics) to reduce the incidence of adverse reactions and other issues. In addition, traditional muscle relaxants may also cause complications, such as postoperative residual curarization (PORC). PORC is associated with weakness of upper airway muscles and increased risk of hypoventilation and hypoxemia, as well as risk for aspiration and postoperative pulmonary complications.
Sugammadex is a new selective relaxant-binding agent that quickly and effectively reverses the effects of steroidal NMBAs, especially rocuronium and vecuronium. Compared with neostigmine, sugammadex more substantially reduces PORC, but its effects on postoperative complications require further investigation. Therefore, this study aimed to compare the effects of sugammadex and neostigmine during emergence and extubation after general anesthesia in non-cardiac surgery and interventional procedure.
Detailed description
Investigators will include 100 participants for both groups(Suggammadex and Neostigmine) During anesthesia induction, the same drugs will be administered intravenously (propofol, fentanyl, lidocaine and rocuronium). Rocuronium, a muscle relaxant,is part of the classic triad of anesthesia. In surgery or interventional procedure under general anesthesia, NMBA is needed to relax the muscles of the whole body. Its purpose is to assist the placement of the endotracheal tube, avoid the participants injury due to involuntary movements, and also enables the surgeon to have a better surgical vision, etc. Once the operation or procedure is completed, Investigators will reverse the NMBA and participants are recovered from general anesthesia. Group A will be administered acetylcholinesterase inhibitor (AChEI, such as neostigmine, pyridostigmine, edrophonium), AChEI is used to reverse the efficacy of NMBA and stabilize the participants's vital signs. Group B will be administered sugammadex, a new selective relaxant-binding agent that quickly and effectively reverses the effects of steroidal NMBAs. Both drug should given on the time of train of four[TOF] count 4. Investigators will collect the data include: Blood pressure(extubation, one minute, two minutes and five minutes and ten minutes after), Heart rate, Saturation, extubation time and BIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neostigmine group | Experimental | Drug: Neostigmine and SugammadexThis group will administered neostigmine for reverse the efficacy of neuromuscular blocking agent and stabilize the patient's vital signs. |
| Sugammadex group | Experimental | Drug: Neostigmine and SugammadexThis group will administered Sugammadex for reverse the efficacy of neuromuscular blocking agent and stabilize the patient's vital signs. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age>20year-old
- Go Intervention or operation under general anesthesia
Key exclusion criteria (6 listed)
- Chronic kidney disease(GFR<30 mL/min)
- Allergy to Sugammade/Neostigmine
- Cant extubate on the day of operation/intervention
- Neuromuscular disease
- Difficult airway
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 |
|---|---|---|
| Neostigmine and SugammadexCompare both groups efficacy of reverse the neuromuscular blocking agent | Drug | Neostigmine group, Sugammadex group |
Primary outcome
Extubation time
Time frame: Since administer neostigmine or sugammadex to 30mins after Extubation
Compare both group of extubation time and administer neostigmine or sugammadex
Blood pressure variability(systolic , diastolic and mean blood pressure)
Time frame: Since administer neostigmine or sugammadex to 30mins after Extubation
Compare both group of blood pressure variability and administer neostigmine or sugammadex
Heart rate variability
Time frame: Since administer neostigmine or sugammadex to 30mins after Extubation
Compare both group of heart rate variability and administer neostigmine or sugammadex
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
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REMIfentanil (2 vs. 4 mcg/kg) Facilitated Intubation Without Neuromuscular Blockade Versus Succinylcholine and Rocuronium With Sugammadex for Endotracheal Intubation in Spine Surgery Requiring Motor Evoked Potential Monitoring
Airway Management, Endotracheal Intubation
RecruitingObservational study
Precision TOF-Guided Sugammadex Versus Spontaneous Recovery for Early Extubation in Minimally Invasive Pediatric Cardiac Surgery
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Venous Tourniquet vs. Arterial Tourniquet for Seizure Monitoring in ECT
Major Depressive Disorder, Bipolar Disorder
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neostigmine and Sugammadex in people with Sugammadex, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation time (time frame: Since administer neostigmine or sugammadex to 30mins after Extubation). The study lists 3 primary outcomes in all. 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 10 Mar 2022.