SugammadexNCT04608682
Effect of Muscle Relaxation Reversal on the Success Rate of Motor Evoked Potential Recording
A study testing Sugammadex and Saline in people with Sugammadex and Motor Evoked Potentials, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during surgery without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation.The feasibility of TcMEP interpretation was assessed during partial NMB in adult neurosurgical… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sugammadex, Motor Evoked Potentials
- What is being tested?
- Sugammadex and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2021to 30 Aug 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range from 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I to II
Who cannot join
- BMI ≥35 kg/m-2
- History of epilepsy or use of antiepileptic drugs
- Personal history or family history of malignant hyperthermia
- Allergies to sugammadex; NMBs or other medication(s) used during general anesthesia
- Hemoglobin <110 g/L
- TceMEP stimulation or recorded site infection
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- Preoperative neurological dysfunction in both upper extremities
- Cardiac pacemaker
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: Effect of Intraoperative Muscle Relaxation Reversal on the Success Rate of Motor Evoked Potential Recording
Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during surgery without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation.The feasibility of TcMEP interpretation was assessed during partial NMB in adult neurosurgical patients. However, partial NMB may interfere record of TcMEP monitoring. Sugammadex is the first highly selective antagonist that can reverse NMB. This study aims to evaluate the success rate of intraoperative muscle relax reversal by sugammadex on intraoperative TceMEP recording.
- Conditions
- Sugammadex, Motor Evoked Potentials
- Being tested
- Sugammadex, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
The muscle relaxant infusion will be discontinued and a bolus of sugammadex (2mg/kg) will be given while performing TceMEPs.
SalineDrug
The muscle relaxant infusion will be discontinued and 2ml saline will be infused, TceMEPs monitoring will be performed 5 minutes later.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex group | Experimental | Not described Receives: Drug: Sugammadex |
| control group | Sham comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of TceMEPs
The success rate of Transcranial motor evoked potentials monitoring（TceMEPs）
Measured: 5 minutes after first performing of TceMEPs
Secondary outcomes (7)
Mean value of amplitudes of TceMEPs
Mean value of amplitudes of Transcranial motor evoked potentials monitoring（TceMEPs）in the abductor pollicis brevis muscles of both upper extremities
Measured: 5, 10, 20, 30 and 60 minutes after first performing of TceMEPs
Mean value of latencies of TceMEPs
Mean value of latencies of Transcranial motor evoked potentials monitoring（TceMEPs） in the abductor pollicis brevis muscles of both upper extremities
Measured: 5, 10, 20, 30 and 60 minutes after first performing of TceMEPs.
Thresholds of TceMEPs
The thresholds that are required to obtain a dependable Transcranial motor evoked potentials monitoring（TceMEPs） response.
Measured: 5 minutes after first performing of TceMEPs
respiratory pressure
Peak respiratory pressures
Measured: during the surgery
Adverse effects of sugammadex
Adverse effects of sugammadex such as anaphylaxis (including flushing, oedema, tachycardia and bronchospasm), arrhythmias (heart rate lower than 60bpm), postprocedural pain, nausea and vomiting, fever (body temperature more than 37.3℃ ), and diarrhea, etc
Measured: during the surgery
Incidence of body movement
Incidence of body movement classified as either nociception-induced movement (defined as "coughing" or reflexive limb movement temporally related to MEP stimulation) or excessive field movement (defined as grossly visible movement as determined by surgical and anaesthesia teams).
Measured: during the surgery
Recurrence of neuromuscular blockade
Recurrence of neuromuscular blockade defined as TOFr < 0.9
Measured: time of extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start16 Aug 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SugammadexStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608682
- Sponsor's protocol ID
- WJP20201030
- Status last verified
- Sep 2022
- First submitted
- 25 Oct 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Jian M, Liu H, Liang F, Ma B, Wang L, Zhou Y, Qiao H, Han R, Wang C. Effect of intraoperative muscle relaxation reversal on the success rate of motor evoked potential recording in patients undergoing spinal surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Aug 25;23(1):290. doi: 10.1186/s12871-023-02211-z.
PubMed 37626303Jian M, Ma B, Liu H, Wang C, Liang F, Zhou Y, Qiao H, Han R. Effect of intraoperative muscle relaxation reversal on the success rate of motor-evoked potential recording in patients undergoing spinal surgery: study protocol for a randomised controlled trial. BMJ Open. 2022 May 2;12(5):e056571. doi: 10.1136/bmjopen-2021-056571.
PubMed 35501072
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Muscle Relaxation Reversal on the Success Rate of Motor Evoked Potential Recording
- ClinicalTrials.gov ID
- NCT04608682
- Acronym / sponsor ID
- WJP20201030
- Conditions
- Sugammadex, Motor Evoked Potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 29 Oct 2020 (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.
Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during surgery without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation.The feasibility of TcMEP interpretation was assessed during partial NMB in adult neurosurgical patients. However, partial NMB may interfere record of TcMEP monitoring. Sugammadex is the first highly selective antagonist that can reverse NMB. This study aims to evaluate the success rate of intraoperative muscle relax reversal by sugammadex on intraoperative TceMEP recording.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex group | Experimental | Drug: Sugammadex |
| control group | Sham comparator | Drug: Saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age range from 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I to II
Key exclusion criteria (9 listed)
- BMI ≥35 kg/m-2
- History of epilepsy or use of antiepileptic drugs
- Personal history or family history of malignant hyperthermia
- Allergies to sugammadex; NMBs or other medication(s) used during general anesthesia
- Hemoglobin <110 g/L
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 |
|---|---|---|
| SugammadexThe muscle relaxant infusion will be discontinued and a bolus of sugammadex (2mg/kg) will be given while performing TceMEPs. | Drug | Sugammadex group |
| SalineThe muscle relaxant infusion will be discontinued and 2ml saline will be infused, TceMEPs monitoring will be performed 5 minutes later. | Drug | control group |
Primary outcome
The success rate of TceMEPs
Time frame: 5 minutes after first performing of TceMEPs
The success rate of Transcranial motor evoked potentials monitoring（TceMEPs）
7 secondary outcomes
Mean value of amplitudes of TceMEPs
Time frame: 5, 10, 20, 30 and 60 minutes after first performing of TceMEPs
Mean value of latencies of TceMEPs
Time frame: 5, 10, 20, 30 and 60 minutes after first performing of TceMEPs.
Thresholds of TceMEPs
Time frame: 5 minutes after first performing of TceMEPs
respiratory pressure
Time frame: during the surgery
Adverse effects of sugammadex
Time frame: during the surgery
Incidence of body movement
Time frame: during the surgery
Recurrence of neuromuscular blockade
Time frame: time of extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Derived from this study: PubMed 37626303Jian M, Liu H, Liang F, Ma B, Wang L, Zhou Y, Qiao H, Han R, Wang C. Effect of intraoperative muscle relaxation reversal on the success rate of motor evoked potential recording in patients undergoing spinal surgery: a randomized controlled trial. BMC Anesthesiol. 2023 Aug 25;23(1):290. doi: 10.1186/s12871-023-02211-z.
- Derived from this study: PubMed 35501072Jian M, Ma B, Liu H, Wang C, Liang F, Zhou Y, Qiao H, Han R. Effect of intraoperative muscle relaxation reversal on the success rate of motor-evoked potential recording in patients undergoing spinal surgery: study protocol for a randomised controlled trial. BMJ Open. 2022 May 2;12(5):e056571. doi: 10.1136/bmjopen-2021-056571.
- Individual participant dataSharing planned: Yes
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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.
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 Sugammadex and Saline in people with Sugammadex and Motor Evoked Potentials, run by Beijing Tiantan Hospital at 1 site in China.
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 9 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: finished, as of the sponsor's last update on 21 Sep 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The success rate of TceMEPs (time frame: 5 minutes after first performing of TceMEPs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04608682, which also lists 2 linked publications.
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 21 Sep 2022.