Neuromuscular BlockadePhase 4NCT02562417
Impact of iv Dexamethasone on Reversal of Rocuronium-induced Neuromuscular Block by Sugammadex
A Phase 4 study testing Normal saline and IV dexamethasone in people with Neuromuscular Blockade, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Sugammadex is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone may impair the reversal effect of sugammadex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Normal saline and IV dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2016to May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled to undergo microlaryngoscopy and ear-nose-throat endoscopic procedures
Who cannot join
- contraindication to dexamethasone administration
- contraindication to sugammadex administration
- contraindication to rocuronium administration
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Lausanne University Hospital
Lausanne, Canton of Vaud, 1011
About this study
Sugammadex is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone may impair the reversal effect of sugammadex. The objective of this randomised controlled trial is to confirm in the clinical practice these preliminary results.
- Conditions
- Neuromuscular Blockade
- Being tested
- Normal saline, IV dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
IV dexamethasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| No IV dexamethasone | Placebo comparator | Patients will receive an equivalent volume of normal saline. Receives: Drug: Normal saline |
| IV dexamethasone | Experimental | Patients will receive 0.1 mg/kg of dexamethasone. Receives: Drug: IV dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean recovery time for T4/T1 ratio > 90% after sugammadex administration
Measured: surgical procedure
Secondary outcomes (2)
Mean recovery time for T4/T1 ratio > 80% after sugammadex administration
Measured: surgical procedure
Mean recovery time for T4/T1 ratio > 70% after sugammadex administration
Measured: surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startJun 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Why it stopped: Change of practice in the department
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562417
- Sponsor's protocol ID
- CER 478/14
- Status last verified
- Jul 2017
- First submitted
- 28 Sep 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of iv Dexamethasone on Reversal of Rocuronium-induced Neuromuscular Block by Sugammadex
- ClinicalTrials.gov ID
- NCT02562417
- Acronym / sponsor ID
- CER 478/14
- Conditions
- Neuromuscular Blockade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of practice in the department
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 29 Sep 2015 (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 is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone may impair the reversal effect of sugammadex. The objective of this randomised controlled trial is to confirm in the clinical practice these preliminary results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No IV dexamethasone | Placebo comparator | Drug: Normal salinePatients will receive an equivalent volume of normal saline. |
| IV dexamethasone | Experimental | Drug: IV dexamethasonePatients will receive 0.1 mg/kg of dexamethasone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled to undergo microlaryngoscopy and ear-nose-throat endoscopic procedures
Key exclusion criteria (3 listed)
- contraindication to dexamethasone administration
- contraindication to sugammadex administration
- contraindication to rocuronium administration
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 |
|---|---|---|
| Normal saline | Drug | No IV dexamethasone |
| IV dexamethasone | Drug | IV dexamethasone |
Primary outcome
Mean recovery time for T4/T1 ratio > 90% after sugammadex administration
Time frame: surgical procedure
2 secondary outcomes
Mean recovery time for T4/T1 ratio > 80% after sugammadex administration
Time frame: surgical procedure
Mean recovery time for T4/T1 ratio > 70% after sugammadex administration
Time frame: surgical procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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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 Phase 4 study testing Normal saline and IV dexamethasone in people with Neuromuscular Blockade, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 21 Jul 2017. 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 Switzerland. 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 was withdrawn before enrolling participants, so there are no results.
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?
Mean recovery time for T4/T1 ratio > 90% after sugammadex administration (time frame: surgical procedure). 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 21 Jul 2017.