Clinical trial NCT05432570: Use of Muscle Relaxants in Parotidectomy Operation With Neuromonitoring
Official title: Which is More Comfortable in Parotidectomy With Neuromonitoring: Using a Muscle Relaxants and Getting It Back? Not to Use it at All? Single-Blind, Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Muscle Relaxation
Anesthesia Intubation Complication
Airway Complication of Anesthesia
Keywords: parotid surgery
muscle relaxants
airway management
neuromonitoring
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Neuromuscular blockers provide muscle relaxation by blocking the electrical conduction to motor nerves and facilitate endotracheal tube placement while relaxing the whole body for surgical comfort during general anesthesia. Parotid surgery is a procedure performed by ear, nose and throat physicians, and as a complication during this procedure, permanent facial paralysis may develop due to damage to the facial nerve. Intraoperative nerve monitoring is frequently used to avoid this complication. The application of local anesthetic to the vocal cords and into the trachea has been tried and found useful for induction of anesthesia without the use of neuromuscular blockers. In studies conducted with this technique, a standard local anesthetic dose was not specified and local anesthetics were generally administered alone and in high doses. It is expected that anesthesia induction and intubation without the use of muscle relaxants will not affect the comfort of the patient and the procedure, but will increase the surgical time and surgical satisfaction.

Detailed description: A general anesthesia technique is required, which will not only facilitate tracheal intubation during anesthesia but also minimize complications that may develop during and after surgery and/or anesthesia without the neuromuscular blocker effect. For this purpose; Induction techniques can be used without the use of muscle relaxants, which will affect the hemodynamic response less. By applying muscle relaxants, its effect can be expected to disappear completely during surgery, or muscle relaxants such as succinylcholine, which are very short-acting, can be used. However, the use of succinylcholine has almost ceased to be used clinically due to anaphylaxis, severe post-operative muscle pain, increased serum potassium levels, rarely prolonged effects, and other cardiovascular side effects that may develop. Sugammadex, which has recently entered clinical use, can be used to reverse the effect of muscle relaxants. After induction, it is necessary to use high doses of sugammadex to immediately reverse the muscle relaxant effect. Waiting for the effects of muscle relaxants to pass, especially in surgical procedures that require neuromonitoring, prolongs the surgical time. This again leads to high costs. The application of local anesthetic to the vocal cords and into the trachea has been tried and found useful for induction of anesthesia without the use of neuromuscular blockers. In studies conducted with this technique, a standard local anesthetic dose was not specified and local anesthetics were generally administered alone and in high doses. Therefore, local anesthetic administered together with the inhalation agent during induction may provide better comfort during tracheal intubation. It is expected that anesthesia induction and intubation without the use of muscle relaxants will not affect the comfort of the patient and the procedure, but will increase the surgical time and surgical satisfaction.

Eligibility criteria: Inclusion Criteria:

* ASA 1-2
* Age between 18-65y
* Mallampati 1-2
* Patients who will undergo elective paratidectomy

Exclusion Criteria:

* History of head and neck surgery
* Body mass index less than 19 or greater than 30
* Muscle relaxant allergy
* Lidocaine allergy
* IDS score \>5
* Patients whose hunger is not suitable
* Uncontrolled hypertension, bronchial asthma, tracheal pathology
* undergoing emergency surgery
* Cases that cannot give informed consent

Primary outcomes:
measure: Difficulty of Intubation
timeFrame: during intubation after induction of anesthesia
measure: Difficulty of Laryngoscopy
timeFrame: during intubation after induction of anesthesia
measure: Number of Intubation Attempts
timeFrame: during intubation after induction of anesthesia]
Secondary outcomes:
measure: Sore throat
timeFrame: up to 24 hours postoperative period
measure: Dysphagia
timeFrame: up to 24 hours postoperative period
measure: Laryngospasm
timeFrame: up to 24 hours postoperative period
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Study Principal Investigator
name: Ismail Sumer, MD
role: PRINCIPAL_INVESTIGATOR
References: