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Clinical Trials/NCT04574947
NCT04574947CompletedPhase 4

Intravenous Or Topical Lidocaine And Neuromonitoring in Thyroid Surgery (IOLANT Study)

Saint Petersburg State University, Russia1 site in 1 country110 target enrollmentStarted: January 25, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
110
Locations
1
Primary Endpoint
Quality of recovery 40 questionnaire

Study Overview

Brief Summary

The aim of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo.

Detailed Description

The use of neuromonitoring in thyroid surgery imposes a number of special demands for anaesthetic management. Such demands include avoiding muscle relaxation and local anaesthesia. Maintaining a balance between the risk of awakening during surgery and excessively deep anaesthesia in fast track surgery is an important task for the anaesthesiologist.

Mild anaesthesia in the absence of muscle relaxation increases the risk of developing laryngeal reflexes, coughing during surgery, while excessively deep anaesthesia slows down recovery after surgery and increases the risk of arterial hypotension. The frequency and duration of arterial hypotension, as well as the depth of anesthesia assessed by the Bispectral index, are independent risk factors for postoperative cardiovascular complications and long-term mortality. On the other hand, coughing in response to irritation of the endotracheal tube during recovery from anesthesia is recognized as a risk factor for respiratory and cardiovascular complications, as well as postoperative wound insufficiency.

Optimization the anesthesia by intravenous infusion of lidocaine can improve anesthesia controllability, hemodynamic stability and overall anesthesia recovery rates. Local use of lidocaine, including filling the endotracheal tube cuff with its alkalinized solution, has also been shown to be effective in reducing the frequency of laryngeal reflexes upon awakening after surgery of varying duration. However, the efficacy and safety of local use of lidocaine under neuromonitoring conditions has not been studied. Despite recommendations to avoid the local use of lidocaine for tracheal intubation, there is evidence of the safety of this technique in the absence of a negative impact on the quality of neuromonitoring.

The purpose of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo. At the same time, the investigators assume that recovery after surgery will be comparable with both local and intravenous use. Intergroup differences in arterial hypotension, depth of anesthesia and intraoperative neuromonitoring parameters will also be investigated.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
45 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Planned thyroid surgery
  • Age> 45 years
  • Signed informed consent to participate in the study

Exclusion Criteria

  • Emergency surgery
  • Redo surgery
  • Contraindications for lidocaine use
  • Pregnancy
  • Enrolment to another randomised clinical trial within the last 30 days

Arms & Interventions

Intravenous lidocaine

Active Comparator

Intervention: Intravenous lidocaine (Drug)

Intravenous lidocaine

Active Comparator

Intervention: Intra-cuff placebo (Procedure)

Topical lidocaine

Experimental

Intervention: Intravenous placebo (Drug)

Topical lidocaine

Experimental

Intervention: Intra-cuff lidocaine (Procedure)

Placebo

Placebo Comparator

Intervention: Intravenous placebo (Drug)

Placebo

Placebo Comparator

Intervention: Intra-cuff placebo (Procedure)

Outcomes

Primary Outcomes

Quality of recovery 40 questionnaire

Time Frame: First postoperative day

Minimum and maximum values: 40 and 200, where higher scores mean a better outcomes

Secondary Outcomes

  • Minimal bispectral index(During surgery)
  • Bispectral index less then 40(During surgery)
  • Hypotension incidence(Intraoperative)
  • Cough rate(In the operating room and during awakening.)
  • Amplitude(During surgery)
  • Hypotension duration(Intraoperative)
  • Latency(During surgery)

Investigators

Sponsor
Saint Petersburg State University, Russia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Efremov Sergey

Principal investigator

Saint Petersburg State University, Russia

Study Sites (1)

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