Intravenous Lidocaine Plus Intratracheal Dexmedetomidine on Postoperative Sore Throat

NCT ID: NCT06952309

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2025-09-25

Brief Summary

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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.

Detailed Description

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Conditions

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Dexmedetomidine Lidocaine Sore Throat

Keywords

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dexmedetomidine lidocaine thyroid surgery sore throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Intravenous lidocaine

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Intracheal dexmedetomidine

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Intravenous lidocaine combined with intracheal dexmedetomidine

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Saline (NaCl 0,9 %) (placebo)

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anqing Municipal Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Xu Siqi

Role: CONTACT

Other Identifiers

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Xuwen531

Identifier Type: -

Identifier Source: org_study_id