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Completed

NCT Number: NCT05126108

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Surgical anesthesia service - Cochin Hospital

Paris, IDF, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thyroid and parathyroid surgery

Procedure

Thyroid and parathyroid surgery

Recurrent nerves monitoring

Other

Recurrent nerves monitoring

Primary outcomes

  1. 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

Secondary outcomes

  1. Copenhagen score

    Time frame: During surgery

    Evaluate the intubation conditions 3 minutes after the injection of rocuronium

  2. Arterial pressions

    Time frame: During surgery

    Evaluate the hemodynamic variations induced by anesthetic induction

  3. Cardiac frequency

    Time frame: During surgery

    Evaluate the hemodynamic variations induced by anesthetic induction

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Evaluation of the Decurarisation Kinetics of Rocuronium in Cervical Surgery

Acronym: CIDEROC

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2021
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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