Use of Muscle Relaxants in Parotidectomy Operation With Neuromonitoring

Intubation; Difficult or Failed Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05432570
• Other study ID #: Ismail03
• Status: Completed
• Phase: N/A
• Start date: June 30, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Complication of Anesthesia
• Anesthesia Intubation Complication
• Intubation; Difficult or Failed
• Muscle Hypotonia
• Muscle Relaxation

Intervention

Procedure:
• Group A - Muscle Relaxants Used
Induction will be achieved with 1 mg/kg lidocaine, 2 µg/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium stored at 4 degrees. After the induction, laryngoscopy will be performed with a Macintosh laryngoscope after 2 minutes of manual ventilation after muscle relaxant by an anesthesiologist with at least 4 years of experience. It will be intubated with a tube with an inner diameter of 8 mm for men and 7 mm for women. The cuff of the intubation tube will be connected to a manometer and inflated at a pressure of 20-30 mmHg until there is no air leak. Intubation will be confirmed by the appearance of end-tidal CO2.
• Group B - No Muscle Relaxants
Induction will be provided with 1 mg/kg lidocaine, 2 µg/kg fentanyl, 2 mg/kg propofol. After ventilation, vocal cords will be seen with a Macintosh laryngoscope, and 2cc of 2% lidocaine will be applied to the vocal cords as a spray with the help of a 5 ml injector. After ventilation, laryngoscopy will be performed with a Macintosh laryngoscope by an anesthesiologist with at least 4 years of experience. It will be intubated with a tube with an inner diameter of 8 mm for men and 7 mm for women. The cuff of the intubation tube will be connected to a manometer and inflated at a pressure of 20-30 mmHg until there is no air leak. Intubation will be confirmed by the appearance of end-tidal CO2.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difficulty of Intubation	The intubation difficulty scale (IDS) of patients will be used to determine the difficulty of intubation during laryngoscopy, and the Helbo-Hansen scoring system-Steyn Modification will be used to determine the quality of laryngoscopy.; Intubation Difficulty Scale (IDS) score, which is a function of seven parameters, resulting in a progressive, quantitative determination of intubation complexity.; intubation difficulty may be defined as a measure of the degree of divergence from a predefined "ideal" intubation, i.e., one performed without effort, on the first attempt, practiced by one operator, using one technique, with full visualization of the laryngeal aperture and vocal cords abducted. Such an intubation is accorded an IDS value of 0. Each variation from this defined "ideal" intubation increases the degree of difficulty, the overall score being the sum of all variations from this definition. Impossible intubation is defined by infinity (IDS =[infinity]).	during intubation after induction of anesthesia
Primary	Difficulty of Laryngoscopy	The Helbo-Hansen scoring system-Steyn Modification will be used to determine the quality of laryngoscopy.; Helbo-Hensen et al. with Steyn modification includes five criteria; ease of laryngoscopy, degree of coughing, position of vocal cords, jaw relaxation, and limb movement and graded on a 4-point scale.Total score of 5 will considere to be excellent, 6-10 good, 11-15 poor, and 16-20 bad. Total scores will divide into clinically acceptable and not acceptable scores (total score = 10 acceptable, >10 unacceptable).	during intubation after induction of anesthesia
Primary	Number of Intubation Attempts	The number of intubation attempts between both groups will be recorded. that patients are intubated will be confirmed by the presence of end tidal carbon dioxide.	during intubation after induction of anesthesia]
Secondary	Sore throat	Sore throat of the patients was evaluated as present or absent at the postoperative 30th minute, 2,6 and 24 hours by the patient.	up to 24 hours postoperative period
Secondary	Dysphagia	Dysphagia of the patients was evaluated as present or absent at the postoperative 30th minute, 2,6 and 24 hours by the patient.	up to 24 hours postoperative period
Secondary	Laryngospasm	Laryngospasm of the patients was evaluated as present or absent at the postoperative 30th minute, 2,6 and 24 hours by the patient.	up to 24 hours postoperative period