Low-dose Rocuronium Effect Neural Monitoring in Thyroid Surgery
Primary Purpose
Thyroid
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intraoperative nerve monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid focused on measuring Intraoperative nerve monitoring, Train of four (TOF), Rocuronium, Operation Time
Eligibility Criteria
Inclusion Criteria:
- Clinical and radiological diagnosis of nodular or multinodular goiter
- Clinical, radiological and pathologicllay diagnosed thyroid cancer
- Must be able to speak( for voice recording)
Exclusion Criteria:
- Pregnancy
- Previous thyroid surgery
- Previous laryngeal surgery
- Professional voice users( e.g. singers)
Sites / Locations
- Bakırkoy Sadi Konuk Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Low Dose Rocuronium
Strandart Dose Rocuronium
Arm Description
This group patients will determine as those who were administered 0.3 mg/kg rocuronium
This group patients will determine as those who were administered 0.6 mg/kg rocuronium
Outcomes
Primary Outcome Measures
Nerve signal detection time
Variation of nerve signal detection time with dose of rocuronium
Secondary Outcome Measures
Operation time
Comparison of differences in operation time period between the groups whether IONM
Full Information
NCT ID
NCT04230915
First Posted
November 25, 2019
Last Updated
January 13, 2020
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04230915
Brief Title
Low-dose Rocuronium Effect Neural Monitoring in Thyroid Surgery
Official Title
Low-dose Rocuronium Provides Adequate Muscle Relaxation and Increases the Effectiveness of Intraoperative Neural Monitoring in Thyroid Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Anticipated)
Primary Completion Date
April 29, 2020 (Anticipated)
Study Completion Date
April 29, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
For the patients who were taken to the operation table, EKG, SPO2, TA, TOF monitorization will be performed and the values will be recorded during the operation. The anesthesia induction of both groups will be done with 3 mg/kg propofol, 2 mg/kg fentanyl and rocuronium bromide according to the relevant group and an intubation tube with the appropriate number and having the IONM electrode will be used as intubation tube for each patient (NIM).
The neuromuscular blockade was followed up quantitatively with an acceleromiograph (TOF Guard; Organon Teknika NV, Turnhout, Belgium). The stimulation of the ulnar nerve and acceleration measurements for the adductor pollicis muscle were used for the acceleromiography. Electrodes were placed on the ulnar nerve at the volar surface of the wrist. The distal electrode was placed at the point where the proximal bending line passed to the radial side of the flexor carpi ulnaris muscle.
The proximal electrode was placed 2 or 3 cm proximally on the distal electrode. The converter (TOF-Watch Handadapter; Organon) was positioned in a way that the largest flat surface corresponds to the thumb. The converting cable was placed so that no traction was applied to the converter and the movement of the thumb was not restricted in any way.
Following the anesthesia induction, rocuronium was administered to the group at an appropriate dosage and the patients who had a TOF value below 90% were intubated. The EMG endotracheal tube (Nerve Integrity Monitor [NIM]; Medtronic Xomed, Jacksonville, FL) was placed directly by an anesthesiologist with laryngoscopy. The position of the electrodes was checked by a laryngoscopic examination after the patient's neck was placed in the full extension position according to our standard IONM procedures.
The anesthesia maintenance after induction was achieved with 2-3% severane and 0.05-0.2 micgr / kg remifentanil. A 40 mg-propofol was added as the recovery dose during the surgery.
Vagal stimulation is the routine procedure prior to the definition of RLN during thyroid operation. This step is important to ensure that the monitoring system is working correctly and that the RLN remains on a normal path. The vagus nerve was found first when the skin flap was removed.
The nerve was then stimulated every 5 min after 30 to 70 minutes following the administration of the rocuronium. 8 EMG signals were measured at 30th, 35th, 40th, 45th, 50th, 55th, 60th, and 70th minutes, respectively. To obtain an EMG response, the vagus nerve was directly touched with a 2 mA monopolar nerve stimulus bar (Prass; Medtronic Xomed).
The Helbo-Hansen score (Steyn's modification, Table1) was used to evaluate the ease of intubation. The sum of the scores of these five individual variables was calculated as the Helbo-Hansen score (Steyn's modification, Table 1). A total score of 5 points was considered to be excellent, 6-10 points to be good, 11-15 points to be bad, and 16-20 points to be too bad.
The statistical analysis of continuous variables between groups was compared using 2 samples t-tests. The intra-group statistical analyses of continuous variables were compared by using the paired t-test. The categorical nominal variables were analyzed by the chi-square test or Fisher's exact test. All statistical tests were 2-tailed and the probability of p<0.05 was considered as statistically significant. All data were expressed as mean ± standard deviation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid
Keywords
Intraoperative nerve monitoring, Train of four (TOF), Rocuronium, Operation Time
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Dose Rocuronium
Arm Type
Active Comparator
Arm Description
This group patients will determine as those who were administered 0.3 mg/kg rocuronium
Arm Title
Strandart Dose Rocuronium
Arm Type
No Intervention
Arm Description
This group patients will determine as those who were administered 0.6 mg/kg rocuronium
Intervention Type
Other
Intervention Name(s)
Intraoperative nerve monitoring
Intervention Description
This group will determine as those who were administered 0.3 mg/kg rocuronium,
Primary Outcome Measure Information:
Title
Nerve signal detection time
Description
Variation of nerve signal detection time with dose of rocuronium
Time Frame
Duration of surgery, up to 3 hours
Secondary Outcome Measure Information:
Title
Operation time
Description
Comparison of differences in operation time period between the groups whether IONM
Time Frame
Duration of surgery, up to 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical and radiological diagnosis of nodular or multinodular goiter
Clinical, radiological and pathologicllay diagnosed thyroid cancer
Must be able to speak( for voice recording)
Exclusion Criteria:
Pregnancy
Previous thyroid surgery
Previous laryngeal surgery
Professional voice users( e.g. singers)
Facility Information:
Facility Name
Bakırkoy Sadi Konuk Training and Research Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Low-dose Rocuronium Effect Neural Monitoring in Thyroid Surgery
We'll reach out to this number within 24 hrs