Decurarisation Kinetics of Rocuronium in Cervical Surgery
- Conditions
- Thyroid and Parathyroid SurgeryNon-morbidly Obese Patients (BMI<35)Equiring General Anesthesia With Intubation With a Nerve Integrity Monitor (NIM) Tube
- Registration Number
- NCT05126108
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quality intraoperative monitoring of the recurrent laryngeal nerve 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 Outcome Measures
Name Time Method Arterial pressions During surgery Evaluate the hemodynamic variations induced by anesthetic induction
Copenhagen score During surgery Evaluate the intubation conditions 3 minutes after the injection of rocuronium
Cardiac frequency During surgery Evaluate the hemodynamic variations induced by anesthetic induction
Trial Locations
- Locations (1)
Surgical anesthesia service - Cochin Hospital
🇫🇷Paris, IDF, France