Intravenous Lidocaine Plus Intratracheal Dexmedetomidine on Postoperative Sore Throat

April 28, 2025 updated by: Anqing Municipal Hospital

Effect of Intravenous Lidocaine Combined With Intratracheal Dexmedetomidine on Postoperative Throat Pain in Patients Undergoing Thyroid Cancer Surgery

Objective: The present study was to investigate the effect of intravenous lidocaine combined with intratracheal dexmedetomidine on postoperative sore throat in patients undergoing thyroid cancer surgery.

Methods: Investigators enrolled 144 patients with American Society of Anesthesiologists (ASA) physical status I and II, aged 18-65 years, and scheduled for elective undergoing thyroid cancer surgery with general anesthesia. The participants were randomly assigned into four groups(n=36 each group): Group L received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia. Group D received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL). Group LD received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL). Group C received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia.The incidence and severity of postoperative sore throat were recorded in four groups at 1 h, 2 h, 6 h, 24 h and 48 h after operation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

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 Contact

  • Name: Xu Siqi

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Thyroid cancer surgery with ASA grades I-II
  • Aged 18-65 years
  • The patient's communication is normal and they have a certain learning ability

Exclusion Criteria:

  • Severe respiratory and circulatory system diseases
  • There was bradycardia (HR < 60 beats/minute) or atrioventricular block before the operation
  • Nervous system disease
  • Mental and psychological disorders
  • Abnormal liver and kidney functions
  • Pregnant and lactating women

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravenous lidocaine
Group L received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia
Drug: Intravenous lidocaine
Group L received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia
Experimental: Intracheal dexmedetomidine
Group D received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia
Drug: Intracheal dexmedetomidine
Group D received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia
Experimental: Intravenous lidocaine combined with intracheal dexmedetomidine
Group LD received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia
Drug: Intravenous lidocaine combined with intracheal dexmedetomidine
Group LD received lidocaine 1.5 mg/kg was injected intravenously 3 min before endotracheal intubation and tracheal spray with dexmedetomidine (1 μg/kg) mixed with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia
Experimental: Saline
Group C received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia
Drug: Saline (NaCl 0,9 %) (placebo)
Group C received equal volume normal saline was injected intravenously 3 min before tracheal intubation and tracheal spray with 0.8% ropivacaine 40 mg (5 mL) for surface anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence and severity of postoperative sore throat
Time Frame: at 1 hour, 2 hour, 6 hour, 24 hour and 48 hour after operation
at 1 hour, 2 hour, 6 hour, 24 hour and 48 hour after operation

Collaborators and Investigators

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

Sponsor

Anqing Municipal Hospital

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 (Estimated)

April 25, 2025

Primary Completion (Estimated)

September 15, 2025

Study Completion (Estimated)

September 25, 2025

Study Registration Dates

First Submitted

April 20, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xuwen531

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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