Effect of Nebulized Lidocaine on Postoperative Sore Throat
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|ClinicalTrials.gov Identifier: NCT03779516|
Recruitment Status : Terminated (change in procedure)
First Posted : December 19, 2018
Last Update Posted : April 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Sore Throat||Other: Saline Other: Lidocaine||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Preoperative Nebulized Lidocaine on Postoperative Sore Throat After Endotracheal Intubation|
|Actual Study Start Date :||December 19, 2018|
|Actual Primary Completion Date :||April 22, 2019|
|Actual Study Completion Date :||July 15, 2019|
Active Comparator: Group C
In Control Group, 4 mL of saline solution was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min
Effect of saline on postoperative sore throat
Active Comparator: Group L
In Lidocaine Group 4 mL of 4% lidocaine was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min
Effect of nebulized lidocaine on postoperative sore throat
- Changes in the incidence of postoperative sore throat [ Time Frame: 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.
- whether the hoarseness was present or not [ Time Frame: 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".
- Intraoperative opioid consumption [ Time Frame: 60 minutes ]Assessed in intraoperative period
- Postoperative analgesic consumption [ Time Frame: 24 hours ]Assessed in postoperative period
- Changes in mean arterial pressure [ Time Frame: 60 minutes ]Assessed every 5 minutes during the procedure
- Changes in heart rate [ Time Frame: 60 minutes ]Assessed every 5 minutes during the procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03779516
|Antalya Training and Research Hospital|
|Principal Investigator:||Ali Sait Kavakli, MD||Antalya Training and Research Hospital|
|Principal Investigator:||Hilal Yavuzel, MD||Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital|
|Principal Investigator:||Ulku Arslan, MD||Karabuk University Training and Research Hospital|