Decurarisation Kinetics of Rocuronium in Cervical Surgery (CIDEROC)

September 5, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- IDF
  - Paris, IDF, France, 75014
    - Surgical anesthesia service - Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Copenhagen score Time Frame: During surgery	Evaluate the intubation conditions 3 minutes after the injection of rocuronium	During surgery
Arterial pressions Time Frame: During surgery	Evaluate the hemodynamic variations induced by anesthetic induction	During surgery
Cardiac frequency Time Frame: During surgery	Evaluate the hemodynamic variations induced by anesthetic induction	During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC Necker Cochin, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2022

Primary Completion (Actual)

May 30, 2022

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria