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Use of Muscle Relaxants in Parotidectomy Operation With Neuromonitoring

B

Bezmialem Vakif University

Status

Completed

Conditions

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

Treatments

Procedure: Group B - No Muscle Relaxants
Procedure: Group A - Muscle Relaxants Used

Study type

Interventional

Funder types

Other

Identifiers

NCT05432570
Ismail03

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Group A - Muscle Relaxants Used
Active Comparator group
Description:
Muscle Relaxants Used
Treatment:
Procedure: Group A - Muscle Relaxants Used
Group B - No Muscle Relaxants
Active Comparator group
Description:
No Muscle Relaxants
Treatment:
Procedure: Group B - No Muscle Relaxants

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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