Decurarisation Kinetics of Rocuronium in Cervical Surgery

NCT ID: NCT05126108

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2022-05-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Thyroid and parathyroid surgery

Thyroid and parathyroid surgery

Intervention Type: PROCEDURE

Recurrent nerves monitoring

Recurrent nerves monitoring

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Surgical anesthesia service - Cochin Hospital

Paris, IDF, France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 36889437 (View on PubMed)

Other Identifiers

APHP210278

Identifier Type: -

Identifier Source: org_study_id