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临床试验/NCT04230915
NCT04230915Unknown不适用

Low-dose Rocuronium Provides Adequate Muscle Relaxation and Increases the Effectiveness of Intraoperative Neural Monitoring in Thyroid Surgery

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Nerve signal detection time

研究概览

简要总结

Intraoperative Neuromonitoring (IONM) was started to be used by surgeons to help prevent laryngeal nerve (RLN) damage during thyroid and parathyroid operations. IONM can be used to localize and identify RLN intraoperatively, to evaluate vocal function after thyroid resection, and to explain the mechanism of RLN injury. However, an important problem in the routine use of IONM is the effect of neuromuscular blocking agents (NMBAs). The use of NMBAs in general anesthesia is essential to provide clinically acceptable tracheal intubation conditions and to prevent laryngeal trauma. However, NMBAs may be the potential cause of a false-negative response during the IONM. Randolph et al. proposed short-acting 1-2 mg/kg succinylcholine for enough relaxation and the ease of electromyographic (EMG) endotracheal tube intubation during the IONM. However, succinylcholine, a depolarizing NMBA, is associated with various adverse effects such as cardiac arrhythmia, hyperkalemia, and malignant hyperthermia. Nondepolarizing NMBAs are widely used by most anesthesiologists due to their safe effects, but to the best our knowledge, there is no very short-acting nondepolarizing NMBA. This deficiency creates a problem because the dose and the time point of nerve stimulation are critical for a successful IONM. However, some studies have reported the feasibility of IONM following the administration of nondepolarizing NMBAs during a thyroid operation. Rocuronium is a short-acting and nondepolarizing NMBA type which is widely used for induction in general anesthesia. Although 0.6 mg/kg rocuronium is recommended for standard intubation dose, the ease of intubation can also be provided with 0.3 mg/kg rocuronium or 1.5 mg/kg succinylcholine. Therefore, the present study was designed to compare the effects of IONM with low and standard rocuronium doses in the induction of general anesthesia.

详细描述

The present study was approved by the local Institutional Review Board. A written informed consent form was obtained from each patient. Patients were informed on the purpose of using the INOM system to potentially assist in the localization and identification of RLNS during the operation as well as to evaluate their functions.

The study includes patients between the ages of 18-65 who were implemented total thyroidectomy, those with ASA I-III, patients who were approved by the otolaryngologist to have a normal cord examination before and after surgery and patients operated by 2 surgeons who were general surgery specialists and accepted as endocrine surgery consultants and anesthetized by the only anesthesiologist who was included in the study.

The exclusion criteria were determined as predicted difficult intubation, severe liver or renal dysfunction, asthma, drug abuse, morbid obesity, and the presence of drug use that may affect neuromuscular diseases or neuromuscular transmissions.

The study was designed as a prospective randomized controlled and double-blind study. Accidental numbers were produced in order to prevent selection bias. In the numbers produced, 1: 0,3 mg/kg rocuronium, 2: 0,6 mg/kg rocuronium group was predefined and patients were assigned to groups in this direction. Random numbers made MedCalc 18.2.1. The double-blind study was designed in a way that the anesthesia technician who gave the rocuronium to the anesthesiologist knew, and the anesthesiologist and surgeon who intubated and carried out the TOF and INOM follow-up didn't know the groups.

The group 1 patients were determined as those who were administered 0.3 mg/kg rocuronium, and the group 2 patients as those who were administered 0.6 mg/kg rocuronium.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical and radiological diagnosis of nodular or multinodular goiter
  • Clinical, radiological and pathologicllay diagnosed thyroid cancer
  • Must be able to speak( for voice recording)

排除标准

  • Pregnancy
  • Previous thyroid surgery
  • Previous laryngeal surgery
  • Professional voice users( e.g. singers)

结局指标

主要结局

Nerve signal detection time

时间窗: Duration of surgery, up to 3 hours

Variation of nerve signal detection time with dose of rocuronium

次要结局

  • Operation time(Duration of surgery, up to 3 hours)

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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