SugammadexNCT04471376
The Effect of Sugammadex During Transcranial Electrical Motor Evoked Potential Monitoring in Spinal Surgery
A study testing Sugammadex in people with Sugammadex, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sugammadex
- What is being tested?
- Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2020to 31 Dec 2020
- 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
- 18-65 years
- ASA status I-II
- Patients undergo thoracic or lumbar spinal surgery
- tcMEP monitoring during the surgery
- Informed consent signed by patients
Who cannot join
- BMI ≥35 Kg/m-2
- history of epilepsy or use of antiepileptic drugs, neuromuscular disorder(s)
- history or family history of malignant hyperthermia
- allergies to sugammadex, NMBs or other medication(s) used during general anesthesia
- anemia, hemoglobin <110g/L,
- TcMEPs stimulate or record site infection
Show all 9Show fewer
- preoperative neurological dysfunction in both upper extremities
- cardiac pacemaker
- pregnancy and breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Reversal of Muscle Relaxants During Transcranial Electrical Motor Evoked Potential Monitoring in Patients Undergoing Spinal Surgery
Transcranial motor evoked potential (TcMEP) monitoring is conventionally performed during neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation. However, full blockade offers increased anesthetic management options and facilitates surgery. Here, investigators want to assess the effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.
- Conditions
- Sugammadex
- Being tested
- Sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
Sugammadex group received a rocuronium infusion producing blockade by qualitative train-of-four ≥2 at the ulnar nerve. 2 mg/kg of Sugammadex will be infused when conducting TcMEP
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex group | Active comparator | Not described Receives: Drug: Sugammadex |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amplitude of MEP
mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities
Measured: 5 minutes after dura opening
Secondary outcomes (8)
The amplitude of MEP
Mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities 10, 20, 30 and 60 minutes after dura opening.
Measured: 10, 20, 30 and 60 minutes after dura opening
The latencies of MEPs
Mean value of latencies of TceMEPs in abductor pollicis brevis muscles of both upper extremities
Measured: 5, 10, 20, 30 and 60 minutes after dura opening.
Respiratory parameters
Peak respiratory pressures and incidence of peak insufflation pressure of more than 25cmH2O.
Measured: during the surgery
Adverse effects of sugammadex
Anaphylaxis, arrhythmias, post-procedure pain, nausea and vomiting, fever and diarrhea, etc.
Measured: during and 24 hours after the surgery
Incidence of body movement
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 anesthesia teams).
Measured: during the surgery
Recurrence of neuromuscular blockade
Recurrence of neuromuscular blockade at the end of surgery.
Measured: At the end of surgery
Motor function assessment
SMP-a scale
Measured: 5 days after surgery
Total bleeding volume
Total bleeding volume during the surgery
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start16 Jul 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 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
- 66 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
- Investigators
- Ruquan Han, M.D., Ph.D, Study chair, Department of Anesthesiology, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471376
- Sponsor's protocol ID
- WJP20200708
- Status last verified
- Apr 2021
- First submitted
- 10 Jul 2020
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, statistical analysis plan and informed consent form will be shared beginning 3 months and ending 5 years following 5 years article publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Reversal of Muscle Relaxants During Transcranial Electrical Motor Evoked Potential Monitoring in Patients Undergoing Spinal Surgery
- ClinicalTrials.gov ID
- NCT04471376
- Acronym / sponsor ID
- WJP20200708
- Conditions
- Sugammadex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 15 Jul 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 neurosurgical procedures without or with minimal neuromuscular blockade (NMB) because of its potential interference with signal interpretation. However, full blockade offers increased anesthetic management options and facilitates surgery. Here, investigators want to assess the effect of Sugammadex during TcMEP in adult patients. Sugammadex is designed to encapsulate rocuronium and reverse rocuronium-induced neuromuscular blockade. 64 patients undergoing thoracic or lumbar spinal surgery will be randomly allocated into sugammadex group or control group under a ratio of 1 to 1. Patients will receive either continuous infusion of rocuronium to produce blockade maintained at least two twitches in Train-of-Four (TOF), rocuronium infusion will be discontinued and 2 mg/kg of sugammadex will be infused while dura opening in sugammadex group. Whereas no muscle relaxant will be given after anesthetic induction in control group. The primary aim of this study is to compare mean value of amplitudes of TcMEPs in abductor pollicis brevis muscles of both upper extremities 5 minutes after dura opening.
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 | Active comparator | Drug: Sugammadex |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-65 years
- ASA status I-II
- Patients undergo thoracic or lumbar spinal surgery
- tcMEP monitoring during the surgery
- Informed consent signed by patients
Key exclusion criteria (9 listed)
- BMI ≥35 Kg/m-2
- history of epilepsy or use of antiepileptic drugs, neuromuscular disorder(s)
- history or family history of malignant hyperthermia
- allergies to sugammadex, NMBs or other medication(s) used during general anesthesia
- anemia, hemoglobin <110g/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 |
|---|---|---|
| SugammadexAlso: BridionSugammadex group received a rocuronium infusion producing blockade by qualitative train-of-four ≥2 at the ulnar nerve. 2 mg/kg of Sugammadex will be infused when conducting TcMEP | Drug | Sugammadex group |
Primary outcome
The amplitude of MEP
Time frame: 5 minutes after dura opening
mean value of amplitudes of TceMEPs in abductor pollicis brevis muscles of both upper extremities
8 secondary outcomes
The amplitude of MEP
Time frame: 10, 20, 30 and 60 minutes after dura opening
The latencies of MEPs
Time frame: 5, 10, 20, 30 and 60 minutes after dura opening.
Respiratory parameters
Time frame: during the surgery
Adverse effects of sugammadex
Time frame: during and 24 hours after the surgery
Incidence of body movement
Time frame: during the surgery
Recurrence of neuromuscular blockade
Time frame: At the end of surgery
Motor function assessment
Time frame: 5 days after surgery
Total bleeding volume
Time frame: during the surgery
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 6 Apr 2021.
- Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan and informed consent form will be shared beginning 3 months and ending 5 years following 5 years article publication.
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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.
Ruquan Han, M.D., Ph.D study chair
Department of Anesthesiology, Beijing Tiantan Hospital
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 in people with Sugammadex, 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 5 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 6 Apr 2021. 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. 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 amplitude of MEP (time frame: 5 minutes after dura opening). 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 6 Apr 2021.