Effect of Nebulized Lidocaine on Postoperative Sore Throat

Sore Throat Clinical Trial

Official title:

Effect of Preoperative Nebulized Lidocaine on Postoperative Sore Throat After Endotracheal Intubation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03779516
• Other study ID #: AntalyaTRH 28
• Status: Terminated
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: December 2018
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: July 15, 2019
• Est. primary completion date: April 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis
• Sore Throat

Intervention

Other:
• Saline
Effect of saline on postoperative sore throat
• Lidocaine
Effect of nebulized lidocaine on postoperative sore throat

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the incidence of postoperative sore throat	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.	24 hours
Secondary	whether the hoarseness was present or not	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".	24 hours
Secondary	Intraoperative opioid consumption	Assessed in intraoperative period	60 minutes
Secondary	Postoperative analgesic consumption	Assessed in postoperative period	24 hours
Secondary	Changes in mean arterial pressure	Assessed every 5 minutes during the procedure	60 minutes
Secondary	Changes in heart rate	Assessed every 5 minutes during the procedure	60 minutes