Decurarisation Kinetics of Rocuronium in Cervical Surgery

NCT05126108 | Completed

• 1 other identifier: APHP210278
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  During surgery

Secondary Outcomes (3)

• Copenhagen score

  During surgery

• Arterial pressions

  During surgery

• Cardiac frequency

  During surgery

Interventions

Thyroid and parathyroid surgery PROCEDURE

Thyroid and parathyroid surgery

Recurrent nerves monitoring OTHER

Recurrent nerves monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Surgical anesthesia service - Cochin Hospital

Paris, IDF, 75014, France

Location

Related Publications (1)

• 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.

  PMID: 36889437 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Thyroid (USP)

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 18, 2021
• Study Start: January 6, 2022
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)