Use of Muscle Relaxants in Parotidectomy Operation With Neuromonitoring

NCT05432570 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-14

No results posted yet for this study

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.

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

  • Bezmialem Vakif University

    lead OTHER

Principal Investigators

  • Ismail Sumer, MD · Study Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2022-10-30
Completion
2022-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05432570 on ClinicalTrials.gov