Neuromuscular MonitoringPhase 4NCT02025309
Intraoperative Methylprednisolone and Sugammadex
A Phase 4 study testing Neuromuscular monitorisation in people with Neuromuscular Monitoring and Sugammadex Effect, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Sugammadex, a modified γ-cyclodextrin is a selective relaxant-binding agent that reverses the effects of steroidal neuromuscular blocking agents, rocuronium and vecuronium. It shows its activity by encapsulating these. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuromuscular Monitoring, Sugammadex Effect
- What is being tested?
- Neuromuscular monitorisation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2013to May 2014
- Phase
- Phase 4
- 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
- patient operated under general anesthesia and endothracheal intubation.
- 18-65 years old
- ASA II
Who cannot join
- Neuromuscular desease
- Renal desease
- Liver failure
- Hypersensitivity to the medications used in the study.
- Being on steroid medication
- Pregnanacy, Lactation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine, Ibni Sina Hospital OR
Ankara, 06700
About this study
Official title: Does Intraoperatively Administered Methylprednisolone Prolong the Neuromuscular Blocade Reversal Effect of Sugammadex?
Sugammadex, a modified γ-cyclodextrin is a selective relaxant-binding agent that reverses the effects of steroidal neuromuscular blocking agents, rocuronium and vecuronium. It shows its activity by encapsulating these. Likewise, some other steroid hormones and drugs like flucloxacillin, toremifene, fusidic acid can also be effected. Thus, assuming that methylprednisolone would also be encapsulated by sugammadex and decrease its efficiency, in this study we aimed to compare the recovery times from recuronium-induced muscle relaxation after reversal with sugammadex between patients who receive intraoperative methylprednisolone or not.
After institutional review board (IRB) approval and informed consent, 100 patients will be enrolled in this prospective, single center, controlled study. Anaesthesia will be induced with propofol (3mg/kg) and rocuronium (0.6 mg/kg), followed by sevoflurane maintenance. Patients will be divided randomly into two groups methylprednisolone administered group and control group respectively). Neuromuscular blockade will be monitored using calibrated acceleromyography train-of-four (TOF WATCH SX Organon Ltd, Dublin, Ireland). Once rocuronium-induced neuromuscular blockade recovers spontaneously to TOF-count-two, all patients will receive 2.0 mg/kg of sugammadex. Neuromuscular monitoring will be continued until recovery of the TOF ratio to 0.9 at the ulnar nerve. The time to recovery of TOF to 0.9 will be compared in both groups. The statistical analyses will be performed using Student T Test and Mann-Whitney U test.
- Conditions
- Neuromuscular Monitoring, Sugammadex Effect
- Being tested
- Neuromuscular monitorisation
- Keywords
- train of four, neuromuscular recovery, sugammadex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular monitorisationDevice
Also called Train of Four
| Study group | Role | What they receive |
|---|---|---|
| Group Methylprednisolone | Active comparator | Patient in this group received general anaesthesia for surgical procedures. During the anesthesia management methylprednisolone was administered intravenously (1mg/kg) to the patients in this group. Also neuromuscular monitorisation was performed to assess the train of four ratio at the end of the procedure, after the reversal of neuromuscular block. All patients were followed during the recovery period from general anaesthesia and the time needed to regain a full neuromuscular recovery was noted. For that, the train of four ratio was followed up and the ratio of 0.9 was recorded. Receives: Device: Neuromuscular monitorisation |
| Group Control | Placebo comparator | Patients who received general anaesthesia and endothracheal entubation but who did not recieved methyprednisone during general anaesthesia were enrolled in the study as control group. Neuromuscular monitorisation was performed to assess the train of four ratio at the end of the procedure, after the reversal of neuromuscular block. All patients were followed during the recovery period from general anaesthesia and the time needed to regain a full neuromuscular recovery was noted. For that, the train of four ratio was followed up and the ratio of 0.9 was recorded. Receives: Device: Neuromuscular monitorisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Train of four ratio 0.9
At the end of the procedure, train of four (TOF) monitorisation was continued and once rocuronium-induced neuromuscular blockade recovered spontaneously to TOF-count-two, all patients received 2.0 mg/kg of sugammadex. Then, neuromuscular monitoring was continued until recovery of the TOF ratio to 0.9 at the ulnar nerve. The time needed for the recovery of TOF to 0.9 was noted.
Measured: During the procedure period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular MonitoringStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Ceyda MECO, Ankara University
- Investigators
- Merve Hayriye Kocaoglu, MD, Principal investigator, Ankara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025309
- Sponsor's protocol ID
- 16-627-13
- Status last verified
- Aug 2018
- First submitted
- 24 Dec 2013
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intraoperatively Administered Methylprednisolone Prolong the Neuromuscular Blocade Reversal Effect of Sugammadex?
- ClinicalTrials.gov ID
- NCT02025309
- Acronym / sponsor ID
- 16-627-13
- Conditions
- Neuromuscular Monitoring, Sugammadex Effect
- Keywords
- train of four, neuromuscular recovery, sugammadex
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 1 Jan 2014 (estimated)
- 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.
Sugammadex, a modified γ-cyclodextrin is a selective relaxant-binding agent that reverses the effects of steroidal neuromuscular blocking agents, rocuronium and vecuronium. It shows its activity by encapsulating these. Likewise, some other steroid hormones and drugs like flucloxacillin, toremifene, fusidic acid can also be effected. Thus, assuming that methylprednisolone would also be encapsulated by sugammadex and decrease its efficiency, in this study we aimed to compare the recovery times from recuronium-induced muscle relaxation after reversal with sugammadex between patients who receive intraoperative methylprednisolone or not.
After institutional review board (IRB) approval and informed consent, 100 patients will be enrolled in this prospective, single center, controlled study. Anaesthesia will be induced with propofol (3mg/kg) and rocuronium (0.6 mg/kg), followed by sevoflurane maintenance. Patients will be divided randomly into two groups methylprednisolone administered group and control group respectively). Neuromuscular blockade will be monitored using calibrated acceleromyography train-of-four (TOF WATCH SX Organon Ltd, Dublin, Ireland). Once rocuronium-induced neuromuscular blockade recovers spontaneously to TOF-count-two, all patients will receive 2.0 mg/kg of sugammadex. Neuromuscular monitoring will be continued until recovery of the TOF ratio to 0.9 at the ulnar nerve. The time to recovery of TOF to 0.9 will be compared in both groups. The statistical analyses will be performed using Student T Test and Mann-Whitney U test.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Methylprednisolone | Active comparator | Device: Neuromuscular monitorisationPatient in this group received general anaesthesia for surgical procedures. During the anesthesia management methylprednisolone was administered intravenously (1mg/kg) to the patients in this group. Also neuromuscular monitorisation was performed to assess the train of four ratio at the end of the procedure, after the reversal of neuromuscular block. All patients were followed during the recovery period from general anaesthesia and the time needed to regain a full neuromuscular recovery was noted. For that, the train of four ratio was followed up and the ratio of 0.9 was recorded. |
| Group Control | Placebo comparator | Device: Neuromuscular monitorisationPatients who received general anaesthesia and endothracheal entubation but who did not recieved methyprednisone during general anaesthesia were enrolled in the study as control group. Neuromuscular monitorisation was performed to assess the train of four ratio at the end of the procedure, after the reversal of neuromuscular block. All patients were followed during the recovery period from general anaesthesia and the time needed to regain a full neuromuscular recovery was noted. For that, the train of four ratio was followed up and the ratio of 0.9 was recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient operated under general anesthesia and endothracheal intubation.
- 18-65 years old
- ASA II
Key exclusion criteria (6 listed)
- Neuromuscular desease
- Renal desease
- Liver failure
- Hypersensitivity to the medications used in the study.
- Being on steroid medication
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 |
|---|---|---|
| Neuromuscular monitorisationAlso: Train of Four | Device | Group Control, Group Methylprednisolone |
Primary outcome
Train of four ratio 0.9
Time frame: During the procedure period.
At the end of the procedure, train of four (TOF) monitorisation was continued and once rocuronium-induced neuromuscular blockade recovered spontaneously to TOF-count-two, all patients received 2.0 mg/kg of sugammadex. Then, neuromuscular monitoring was continued until recovery of the TOF ratio to 0.9 at the ulnar nerve. The time needed for the recovery of TOF to 0.9 was noted.
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 7 Aug 2018.
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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.
Merve Hayriye Kocaoglu, MD principal investigator
Ankara University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neuromuscular monitorisation in people with Neuromuscular Monitoring and Sugammadex Effect, run by Ankara University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 7 Aug 2018. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Train of four ratio 0.9 (time frame: During the procedure period.). 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 7 Aug 2018.