Effect of Nebulized Lidocaine on Postoperative Sore Throat

Not Applicable

Terminated

• Conditions: Sore Throat
• Interventions: Other: Lidocaine; Other: Saline

• Registration Number: NCT03779516
• Lead Sponsor: Antalya Training and Research Hospital

Brief Summary

The purpose of this study is to test the hypothesis that use of preoperative nebulized lidocaine is reduced the incidence of postoperative sore throat after endotracheal intubation.

Detailed Description

Adult patients undergoing video-assisted thoracic surgery (VATS) requiring double lumen tube (DLT) endotracheal intubation for one-lung ventilation (OLV) were enrolled in the study. Patients were randomized by means of computer-generated order randomization into two groups: Group C (those who received a saline solution as placebo delivered by nebulization) and Group L (those who received lidocaine delivered by nebulization).

At 1, 6 and 24 h after tracheal extubation, an observer blinded to treatments evaluated the patients in terms of sore throat and hoarseness. In addition, Patients' satisfaction, intraoperative and postoperative opioid and analgesics consumption and complaints such as dysphagia, nausea and vomiting were recorded. Hemodynamic variables such as blood pressure and heart rate were also recorded.

Study Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-17
• Study Start: 2018-12-19
• Study First Posted: 2018-12-19
• Primary Completion: 2019-04-22
• Study Completion: 2019-07-15
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• patients undergoing video-assisted thoracic surgery requiring double lumen tube endotracheal intubation for one-lung ventilation
• American Society of Anesthesiologists class 1,2 and 3
• Ability to consent

Exclusion Criteria

• patients <18 years old
• body mass index (BMI) <20 or >35 kg/m2
• Mallampati grade 3 or 4
• mouth opening < 3 cm
• preexisting hoarseness or sore throat
• coagulopathy
• patient with upper respiratory tract infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group L	Lidocaine	In Lidocaine Group 4 mL of 4% lidocaine was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min
Group C	Saline	In Control Group, 4 mL of saline solution was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min

Primary Outcome Measures

Name	Time	Method
Changes in the incidence of postoperative sore throat	24 hours	Sore throat was assessed using a 0-100 mm visual analog scale (VAS), where a score of 0 represents no pain and a score of 100 reflects the worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Postoperative analgesic consumption	24 hours	Assessed in postoperative period
whether the hoarseness was present or not	24 hours	Hoarseness was defined as a change in voice quality and it was assessed by the patients themselves. The change in voice quality at any time during the observation period was defined as "hoarseness was present".
Changes in mean arterial pressure	60 minutes	Assessed every 5 minutes during the procedure
Changes in heart rate	60 minutes	Assessed every 5 minutes during the procedure
Intraoperative opioid consumption	60 minutes	Assessed in intraoperative period

Trial Locations

Locations (1)

Antalya Training and Research Hospital; 🇹🇷 Antalya, Turkey