Anaesthesia With or Without Rocuronium in Intubation and Intraoperative Nerve-monitoring During Thyroid Surgery.

November 2, 2020 updated by: Federico Longhini

Anaesthesia With or Without Neuromuscular Blocking Agents in Intubation and Intraoperative Nerve-monitoring During Thyroid Surgery: a Feasibility and Safety Pilot Study.

In this randomized controlled trial the investigators want to assess if, compared to controls, the administration of one single low-dose of rocuronium would increase the occurrence of absent or weak (i.e. amplitude <100 μV) signal at V1 and R1, indicating a residual NMBA activity. In addition, we also recorded: 1) the occurrence of difficult laryngoscopy; 2) the time-to-intubation; 3) the occurrence of difficult intubation; 4) the number of intubation attempts; 5) the intubation failure rate; 6) the need for oxygenation between intubation attempts; 7) the lowest peripheral saturation in oxygen (SpO2); 8) the number of severe desaturations; 9) the time-to-V1 and 10) the number of post-surgical complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The lesion of laryngeal nerves is one of the most severe complications, which could be observed during the thyroid and parathyroid surgery. The recent clinical review, relative the problem and based on 27 articles and 25000 patients involved, shows that the incidence of the temporary paralysis of the recurrent laryngeal nerve (RLN) was 9,8%, and the permanent paralysis of the nerve was 2,3%. In the most cases the typical reasons of lesions of RLN are: section, clamping, electrothermic damage, stretching or entrapment of the nerve. The lesions of the RLN could lead to voice disturbance, breathing and swallow alterations. It is also one of the most frequent reasons for legal medicine disputes.

The intraoperative nerve-monitoring (IONM) of the RLN and of the external branch of superior laryngeal nerve (EBSLN) has been suggested as an instrument to limit the risk of post-operative damaging. It was introduced in the 60's, and the method was accepted by surgical community with the great enthusiasm. This technique is based on employment of special electrode, which transmits electrical signal of low amperage and stimulates directly the RLN, evaluating the muscle response. The stimulation of the EBSLN is commonly identified by contractions of cricothyroid muscle. On the other hand, the stimulation of the RLN leads to the response of the relative vocal cord, which could be palpated or observed by means of electromyography (EMG).

For implementation of the good IONM the collaboration between the surgeons and the anaesthesiologists is strongly required, e.g. the vocal cords are been monitored during the operation by means of laryngoscopy or a special endotracheal tube.

The particular role for the anaesthesiologists during the operation is the way of using of muscle relaxants. In fact, long-action agents should be generally avoided to prevent the absence of adequate muscle response, during the IONM.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy
        • AOU Mater Domini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective surgery of the thyroid with the use of Intra-Operative Neuromuscular Monitoring (IONM)

Exclusion Criteria:

  • Patients who suffer from paralysis of vocal cords or diseases of neuromuscular system.
  • Patients with a history of allergy to anaesthetic drugs.
  • Patients who has a high possibility of difficult intubation due to one the following criteria: a) interdental distance < 20 mm; b) marked upper teeth protrusion (mandibular prognathism), which is not possible to correct; c) thyromental distance ≤ 60 mm; d) Mallampati class 4; e) macroglossia with marked micrognathia; f) fixed neck flection; g) severe scar tissue or post radiation fibrosis of the tongue.
  • Patients who has a high possibility of difficult intubation due to two of the following criteria, associated with each other: a) interdental distance < 35 mm; b) moderate prognathism or retrgnathia; c) mentohyoid distance < 40 mm; d) thyromental distance ≤ 65 mm; e) Mallampati class 2-3; f) reduced head-neck flexion and extension; g) Body Mass Index (BMI) > 30 kg/m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rocuronium 0,3 mg/kg

One hour before the operation the patient will receive the midazolam from 1 to 5 mg intravenous. After the adequate preoxigenation and denitrogenation, the induction phase will be performed with the propofol 2 mg/kg intravenous bolus (for the sedation). At the same time continues infusion of remifentanyl (up to 1 mcg/kg/min) will guarantee the adequate anaesthesia.

Patients, who have been randomized to this group, will be obtained single reduced dose of rocuronium (0,3 mg/kg) once intravenous bolus. The dose of rocuronium will be prepared by an external investigator, to leave the anesthesiologist blinded of the group treatment. The drug will be diluited in a syringe with 20 ml of solution.
Drug: Rocuronium 0.3 mg*kg
Patients randomized to the control group will receive rocuronium at 0.3 mg*kg ev bolus at the induction of anesthesia.
Other Names:
  • Neuromuscular blockade
Experimental: No rocuronium

One hour before the operation the patient will receive the midazolam from 1 to 5 mg intravenous. After the adequate preoxigenation and denitrogenation, the induction phase will be performed with the propofol 2 mg/kg intravenous bolus (for the sedation). At the same time continues infusion of remifentanyl (up to 1 mcg/kg/min) will guarantee the adequate anaesthesia.

Patients, who have been randomized to this group, will not receive rocuronium, but normal saline will be administered by the anesthesiologist in charge of the patients. The dose of normal saline (20 ml in one syringe) will be prepared by an external investigator, to leave the anesthesiologist blinded of the group treatment.
Drug: No Rocuronium
Patients randomized to the interventional group will not receive neuromuscular blockade at the induction of anesthesia.
Other Names:
  • No neuromuscular blockade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of absent or weak signal at V1 and R1 (i.e. amplitude <100 μV)
Time Frame: Immediately after vagus and recurrent laryngeal nerve identification
Record of the vagus (V1) and recurrent laryngeal nerve (R1) with the intraoperative neuromuscular monitoring before the dissection of the thyroid
Immediately after vagus and recurrent laryngeal nerve identification

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of intubation
Time Frame: Immediately after successful endotrachel intubation
The time of intubation is intended as the duration from the moment when the anaesthesiologist takes the laryngoscope till the first end-tidal carbon dioxide record
Immediately after successful endotrachel intubation
Rate of difficult intubation
Time Frame: Immediately after successful endotrachel intubation
Difficult orotracheal intubation is defined as an intubation, which requires more than 2 laryngoscopies, which continues more than 10 minutes, or whether it claims the use of alternative devices
Immediately after successful endotrachel intubation
Cormack Lehane scale value
Time Frame: Immediately after successful endotrachel intubation
Evaluation of laryngeal exposition according to Cormack-Lehane (1: Full view of glottis; 2a: Partial view of glottis; 2b: Only posterior extremity of glottis seen or only arytenoid cartilages; 3: Only epiglottis seen, none of glottis seen; 4: Neither glottis nor epiglottis seen)
Immediately after successful endotrachel intubation
V1 time
Time Frame: Immediately after vagus identification
The time passed from the cutaneous incision until the measurement of V1 (pre-dissection stimulation of vagus nerve)
Immediately after vagus identification
incidence of post-operative complication
Time Frame: At 48 hours from surgery
The incidence of post-operative complication (paralysis of RLN, hyporparathyroidism, bleeding or infections of surgical site, dysphagia, post-operative lung complications).
At 48 hours from surgery
Post-dissection vagus stimulation value
Time Frame: Immediately after the complete removal of the thyroid
Record of the vagus stimulation (V2) with the intraoperative neuromuscular monitoring after the dissection of the thyroid
Immediately after the complete removal of the thyroid
Post-dissection recurrent nerve stimulation value
Time Frame: Immediately after the complete removal of the thyroid
Record of the recurrent nerve stimulation (R2) with the intraoperative neuromuscular monitoring at the end of the dissection of the thyroid
Immediately after the complete removal of the thyroid
Pain assessment
Time Frame: Immediately after the end of the surgery
Evaluation of postoperative pain by means of the numeric pain rating scale from 0 (no pain) to 10 (maximal severe pain)
Immediately after the end of the surgery
Predissection recurrent nerve stimulation value
Time Frame: Immediately after recurrent nerve identification
Record of the recurrent nerve stimulation (R1) with the intraoperative neuromuscular monitoring before the dissection of the thyroid
Immediately after recurrent nerve identification
Predissection vagus stimulation value
Time Frame: Immediately after vagus identification
Record of the vagus stimulation (V1) with the intraoperative neuromuscular monitoring before the dissection of the thyroid
Immediately after vagus identification

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico Longhini

Investigators

  • Principal Investigator: Federico Longhini, MD, Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2019

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

February 18, 2019

First Submitted That Met QC Criteria

April 8, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IONM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The full protocol, datasets used and analysed during the current study will be available on reasonable request at the corresponding author

IPD Sharing Time Frame

Data will be available after publication

IPD Sharing Access Criteria

On reasonable request at the corresponding author

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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