Use of Muscle Relaxants in Parotidectomy Operation With Neuromonitoring

NCT ID: NCT05432570

Last Updated: 2023-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2022-12-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Group A - Muscle Relaxants Used

Muscle Relaxants Used

Group Type: ACTIVE_COMPARATOR

Group A - Muscle Relaxants Used

Intervention Type: PROCEDURE

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

No Muscle Relaxants

Group Type: ACTIVE_COMPARATOR

Group B - No Muscle Relaxants

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

İsmail SÜMER

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ismail Sumer, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Ismail03

Identifier Type: -

Identifier Source: org_study_id