Intravenous Lidocaine Plus Intratracheal Dexmedetomidine on Postoperative Sore Throat

NCT06952309 | Not Yet Recruiting

• 1 other identifier: Xuwen531
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dexmedetomidine; Lidocaine; Sore Throat

Keywords

dexmedetomidine; lidocaine; thyroid surgery; sore throat

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of postoperative sore throat

  at 1 hour, 2 hour, 6 hour, 24 hour and 48 hour after operation

Study Arms (4)

Intravenous lidocaine

EXPERIMENTAL

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

Intracheal dexmedetomidine

EXPERIMENTAL

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

Intravenous lidocaine combined with intracheal dexmedetomidine

EXPERIMENTAL

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

Saline

EXPERIMENTAL

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)

Interventions

Intracheal dexmedetomidine 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

Intracheal dexmedetomidine

Intravenous lidocaine 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

Intravenous lidocaine

Intravenous lidocaine combined with intracheal dexmedetomidine 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

Intravenous lidocaine combined with intracheal dexmedetomidine

Saline (NaCl 0,9 %) (placebo) 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

Saline

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anqing Municipal Hospital: lead

MeSH Terms

Conditions

Pharyngitis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Xu Siqi

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 30, 2025
• Study Start: April 25, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 25, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share