- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04230915
Low-dose Rocuronium Effect Neural Monitoring in Thyroid Surgery
Low-dose Rocuronium Provides Adequate Muscle Relaxation and Increases the Effectiveness of Intraoperative Neural Monitoring in Thyroid Surgery
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey
- Bakırkoy Sadi Konuk Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low Dose Rocuronium
This group patients will determine as those who were administered 0.3 mg/kg rocuronium
|
This group will determine as those who were administered 0.3 mg/kg rocuronium,
|
No Intervention: Strandart Dose Rocuronium
This group patients will determine as those who were administered 0.6 mg/kg rocuronium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nerve signal detection time
Time Frame: Duration of surgery, up to 3 hours
|
Variation of nerve signal detection time with dose of rocuronium
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Duration of surgery, up to 3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operation time
Time Frame: Duration of surgery, up to 3 hours
|
Comparison of differences in operation time period between the groups whether IONM
|
Duration of surgery, up to 3 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BakirkoySadiKonuk -2019/154
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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