Non-morbidly Obese Patients (BMI<35)CIDEROCNCT05126108
Decurarisation Kinetics of Rocuronium in Cervical Surgery
An observational study of Non-morbidly Obese Patients (BMI<35) and Equiring General Anesthesia With Intubation With a Nerve Integrity Monitor (NIM) Tube, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Recurrent nerve monitoring for thyroid and parathyroid surgery contraindicates the pharmacologically active presence of muscle relaxant agents at the time of dissection. A recent formalized expert guideline (RFE 2018) from the French Society of Anesthesia and Resuscitation, SFAR recommends administering a curare to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-morbidly Obese Patients (BMI<35), Equiring General Anesthesia With Intubation With a Nerve Integrity Monitor (NIM) Tube, Thyroid and Parathyroid Surgery
- What is being tested?
- Thyroid and parathyroid surgery and Recurrent nerves monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2022to 30 May 2022
- Phase
- Observational
- 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
Study population: Major, non-morbidly obese patients (BMI<35) requiring general anesthesia with intubation with a Nerve Integrity Monitor (NIM) tube for thyroid and parathyroid surgery.
Who may be able to join
- Adult subjects requiring general anesthesia for cephalic surgery (thyroid and parathyroid) with an NIM-type intubation tube.
- Subject informed of the study and not having opposed it
Who cannot join
- Allergy to any of the products used
- Morbidly obese subjects (BMI> 35)
- Pregnancy
- Predictive criteria for difficult intubation in pre-anesthetic consultation
- Subjects under tutorship or curatorship
- Subjects not affiliated to social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Decurarisation Kinetics of Rocuronium in Cervical Surgery
Recurrent nerve monitoring for thyroid and parathyroid surgery contraindicates the pharmacologically active presence of muscle relaxant agents at the time of dissection. A recent formalized expert guideline (RFE 2018) from the French Society of Anesthesia and Resuscitation, SFAR recommends administering a curare to facilitate tracheal intubation and limit laryngeal trauma . This study aims to determine if the level of neuromuscular recovery is consistent with monitoring the recurrent nerve after the use of rocuronium for intubation.
Primary endpoint: Achievement of quality intraoperative laryngeal recurrent nerve monitoring.
Read the detailed description
The monitoring of the recurrent nerves, innervating the vocal cords, in thyroid and parathyroid surgery has developed in recent years because of its interest as a parameter to reduce the risk of recurrent paralysis.
Monitoring of the recurrent nerves requires contraction of the laryngeal muscle and therefore contraindicates the pharmacologically active presence of muscle relaxants at the time of dissection. Thus, intubation was performed either without curare or with a depolarizing curare (Succinylcholine) whose short duration of action allowed optimal intubation conditions without intraoperative residual effect.
This practice is being questioned due to :
(i) a recent formalized expert referential (RFE) of the French Society of Anesthesia and Resuscitation, SFAR, which recommends administering a curare to facilitate intubation of the trachea and limit laryngeal trauma (grade 1 +) and (ii) a restriction of the indications of succinylcholine by the French National Agency for the Safety of Medicines and Health Products, ANSM, as an adjuvant of general anaesthesia (induction in rapid sequence and electroconvulsive therapy).
In summary, thyroid surgery requires curarisation for intubation and sufficient intraoperative decurarisation to allow monitoring of the recurrent nerves. We hypothesize that the time between intubation and the actual start of recurrent monitoring is consistent with the time to recovery of laryngeal adductor neuromuscular block after injection of rocuronium at a dosage of 0.5 mg/kg.
- Conditions
- Non-morbidly Obese Patients (BMI<35), Equiring General Anesthesia With Intubation With a Nerve Integrity Monitor (NIM) Tube, Thyroid and Parathyroid Surgery
- Being tested
- Thyroid and parathyroid surgery, Recurrent nerves monitoring
- Keywords
- Thyroid and parathyroid surgery, Recurrent nerves monitoring, Rocuronium
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thyroid and parathyroid surgeryProcedure or surgery
Thyroid and parathyroid surgery
Recurrent nerves monitoringOther
Recurrent nerves monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality intraoperative monitoring of the recurrent laryngeal nerve
To assess the decurarization kinetics of rocuronium: to determine if the level of neuromuscular recovery is compatible with monitoring of the recurrent nerve after the use of rocuronium for intubation
Measured: During surgery
Secondary outcomes (3)
Copenhagen score
Evaluate the intubation conditions 3 minutes after the injection of rocuronium
Measured: During surgery
Arterial pressions
Evaluate the hemodynamic variations induced by anesthetic induction
Measured: During surgery
Cardiac frequency
Evaluate the hemodynamic variations induced by anesthetic induction
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start6 Jan 2022
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-morbidly Obese Patients (BMI<35)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126108
- Sponsor's protocol ID
- APHP210278
- Acronym
- CIDEROC
- Status last verified
- Sep 2025
- First submitted
- 8 Nov 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marquet Y, Philippe A, Toussaint S, Abdallah SB, Morel-Fatio E, Baillard C. Rocuronium with sugammadex as a rescue reversal agent to solve conflicting recommendations for thyroid or parathyroid surgery. A prospective study. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101214. doi: 10.1016/j.accpm.2023.101214. Epub 2023 Mar 6.
PubMed 36889437
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Decurarisation Kinetics of Rocuronium in Cervical Surgery
- ClinicalTrials.gov ID
- NCT05126108
- Acronym / sponsor ID
- CIDEROC / APHP210278
- Conditions
- Non-morbidly Obese Patients (BMI<35), Equiring General Anesthesia With Intubation With a Nerve Integrity Monitor (NIM) Tube, Thyroid and Parathyroid Surgery
- Keywords
- Thyroid and parathyroid surgery, Recurrent nerves monitoring, Rocuronium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 18 Nov 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.
Recurrent nerve monitoring for thyroid and parathyroid surgery contraindicates the pharmacologically active presence of muscle relaxant agents at the time of dissection. A recent formalized expert guideline (RFE 2018) from the French Society of Anesthesia and Resuscitation, SFAR recommends administering a curare to facilitate tracheal intubation and limit laryngeal trauma . This study aims to determine if the level of neuromuscular recovery is consistent with monitoring the recurrent nerve after the use of rocuronium for intubation.
Primary endpoint: Achievement of quality intraoperative laryngeal recurrent nerve monitoring.
Detailed description
The monitoring of the recurrent nerves, innervating the vocal cords, in thyroid and parathyroid surgery has developed in recent years because of its interest as a parameter to reduce the risk of recurrent paralysis.
Monitoring of the recurrent nerves requires contraction of the laryngeal muscle and therefore contraindicates the pharmacologically active presence of muscle relaxants at the time of dissection. Thus, intubation was performed either without curare or with a depolarizing curare (Succinylcholine) whose short duration of action allowed optimal intubation conditions without intraoperative residual effect.
This practice is being questioned due to :
(i) a recent formalized expert referential (RFE) of the French Society of Anesthesia and Resuscitation, SFAR, which recommends administering a curare to facilitate intubation of the trachea and limit laryngeal trauma (grade 1 +) and (ii) a restriction of the indications of succinylcholine by the French National Agency for the Safety of Medicines and Health Products, ANSM, as an adjuvant of general anaesthesia (induction in rapid sequence and electroconvulsive therapy).
In summary, thyroid surgery requires curarisation for intubation and sufficient intraoperative decurarisation to allow monitoring of the recurrent nerves. We hypothesize that the time between intubation and the actual start of recurrent monitoring is consistent with the time to recovery of laryngeal adductor neuromuscular block after injection of rocuronium at a dosage of 0.5 mg/kg.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major, non-morbidly obese patients (BMI<35) requiring general anesthesia with intubation with a Nerve Integrity Monitor (NIM) tube for thyroid and parathyroid surgery.
Key inclusion criteria (2 listed)
- Adult subjects requiring general anesthesia for cephalic surgery (thyroid and parathyroid) with an NIM-type intubation tube.
- Subject informed of the study and not having opposed it
Key exclusion criteria (6 listed)
- Allergy to any of the products used
- Morbidly obese subjects (BMI> 35)
- Pregnancy
- Predictive criteria for difficult intubation in pre-anesthetic consultation
- Subjects under tutorship or curatorship
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 |
|---|---|---|
| Thyroid and parathyroid surgeryThyroid and parathyroid surgery | Procedure or surgery | – |
| Recurrent nerves monitoringRecurrent nerves monitoring | Other | – |
Primary outcome
Quality intraoperative monitoring of the recurrent laryngeal nerve
Time frame: During surgery
To assess the decurarization kinetics of rocuronium: to determine if the level of neuromuscular recovery is compatible with monitoring of the recurrent nerve after the use of rocuronium for intubation
3 secondary outcomes
Copenhagen score
Time frame: During surgery
Arterial pressions
Time frame: During surgery
Cardiac frequency
Time frame: During 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 12 Sep 2025.
- Results publication: PubMed 36889437Marquet Y, Philippe A, Toussaint S, Abdallah SB, Morel-Fatio E, Baillard C. Rocuronium with sugammadex as a rescue reversal agent to solve conflicting recommendations for thyroid or parathyroid surgery. A prospective study. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101214. doi: 10.1016/j.accpm.2023.101214. Epub 2023 Mar 6.
- Individual participant dataSharing planned: No
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?
An observational study of Non-morbidly Obese Patients (BMI<35) and Equiring General Anesthesia With Intubation With a Nerve Integrity Monitor (NIM) Tube, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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: finished, as of the sponsor's last update on 12 Sep 2025. 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 France. 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?
Quality intraoperative monitoring of the recurrent laryngeal nerve (time frame: During surgery). 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 NCT05126108, which also lists 1 linked publication.
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 12 Sep 2025.