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

NCT03910504 | Completed DMC

• 1 other identifier: IONM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thyroid; Neuromuscular Blockade; Anesthesia Complication; Anesthesia Intubation Complication

Outcome Measures

Primary Outcomes (1)

• Occurrence of absent or weak signal at V1 and R1 (i.e. amplitude <100 μV)

  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 Outcomes (10)

• Time of intubation

  Immediately after successful endotrachel intubation

• Rate of difficult intubation

  Immediately after successful endotrachel intubation

• Cormack Lehane scale value

  Immediately after successful endotrachel intubation

• V1 time

  Immediately after vagus identification

• incidence of post-operative complication

  At 48 hours from surgery

Study Arms (2)

Rocuronium 0,3 mg/kg

ACTIVE COMPARATOR

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

No rocuronium

EXPERIMENTAL

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

Interventions

Rocuronium 0.3 mg*kg DRUG

Patients randomized to the control group will receive rocuronium at 0.3 mg\*kg ev bolus at the induction of anesthesia.

Also known as: Neuromuscular blockade

Rocuronium 0,3 mg/kg

No Rocuronium DRUG

Patients randomized to the interventional group will not receive neuromuscular blockade at the induction of anesthesia.

Also known as: No neuromuscular blockade

No rocuronium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico Longhini: lead

Study Sites (1)

AOU Mater Domini

Catanzaro, Italy

Location

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Neuromuscular Blockade

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Investigative Techniques

Study Officials

• Federico Longhini, MD

  Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: April 10, 2019
• Study Start: April 17, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after publication
• Access Criteria: On reasonable request at the corresponding author

Locations

IT (1)