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Decurarisation Kinetics of Rocuronium in Cervical Surgery

Evaluation of the Decurarisation Kinetics of Rocuronium in Cervical Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05126108
Acronym
CIDEROC
Enrollment
50
Registered
2021-11-18
Start date
2022-01-06
Completion date
2022-05-30
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Equiring General Anesthesia With Intubation With a Nerve Integrity Monitor (NIM) Tube, Non-morbidly Obese Patients (BMI<35), Thyroid and Parathyroid Surgery

Keywords

Thyroid and parathyroid surgery, Recurrent nerves monitoring, Rocuronium

Brief 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 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.

Interventions

PROCEDUREThyroid and parathyroid surgery

Thyroid and parathyroid surgery

OTHERRecurrent nerves monitoring

Recurrent nerves monitoring

Sponsors

URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Quality intraoperative monitoring of the recurrent laryngeal nerveDuring surgeryTo 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

Secondary

MeasureTime frameDescription
Copenhagen scoreDuring surgeryEvaluate the intubation conditions 3 minutes after the injection of rocuronium
Arterial pressionsDuring surgeryEvaluate the hemodynamic variations induced by anesthetic induction
Cardiac frequencyDuring surgeryEvaluate the hemodynamic variations induced by anesthetic induction

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026