NCT04574947

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

2.7 years

First QC Date

September 24, 2020

Last Update Submit

March 20, 2024

Conditions

Thyroid NeoplasmParathyroid NeoplasmsAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Quality of recovery 40 questionnaire

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

    First postoperative day

Secondary Outcomes (7)

  • Hypotension incidence

    Intraoperative

  • Hypotension duration

    Intraoperative

  • Cough rate

    In the operating room and during awakening.

  • Minimal bispectral index

    During surgery

  • Bispectral index less then 40

    During surgery

  • +2 more secondary outcomes

Study Arms (3)

Intravenous lidocaine

ACTIVE COMPARATOR
Drug: Intravenous lidocaineProcedure: Intra-cuff placebo

Topical lidocaine

EXPERIMENTAL
Drug: Intravenous placeboProcedure: Intra-cuff lidocaine

Placebo

PLACEBO COMPARATOR
Drug: Intravenous placeboProcedure: Intra-cuff placebo

Interventions

Intravenous lidocaineDRUG

Lidocaine IV 1.5 mg / kg BMI will be administered during induction into anaesthesia followed by infusion at a dose of 1.5 mg / kg / h until the end of the surgery.

Intravenous lidocaine
Intravenous placeboDRUG

During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution.

PlaceboTopical lidocaine
Intra-cuff lidocainePROCEDURE

The lidocaine solution will be applied to the intubation tube and the cuff will be filled with an alkalinised lidocaine solution.

Topical lidocaine
Intra-cuff placeboPROCEDURE

The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.

Intravenous lidocainePlacebo

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Petersburg State University Hospital

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Thyroid NeoplasmsParathyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesParathyroid Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 24, 2020

First Posted

October 5, 2020

Study Start

January 25, 2021

Primary Completion

October 15, 2023

Study Completion

December 31, 2023

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

RU(1)