An interventional study of Saline and Lidocaine in Sore Throat, sponsored by Antalya Training and Research Hospital. Terminated at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-30.
Sponsored by Antalya Training and Research Hospital · Not applicable, Interventional, and Prevention
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.
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.
252 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's enrollment of 110 is below the median of 145 across 208 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →Antalya Training and Research Hospital is the lead sponsor of 102 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
In Control Group, 4 mL of saline solution was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min
Other: Saline
In Lidocaine Group 4 mL of 4% lidocaine was administered using a face mask and a compressed gas-powered jet nebulizer for 15 min
Other: Lidocaine
Effect of saline on postoperative sore throat
Effect of nebulized lidocaine on postoperative sore throat
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.
Time frame: 24 hours
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".
Time frame: 24 hours
Intraoperative opioid consumption
Assessed in intraoperative period
Time frame: 60 minutes
Postoperative analgesic consumption
Assessed in postoperative period
Time frame: 24 hours
Changes in mean arterial pressure
Assessed every 5 minutes during the procedure
Time frame: 60 minutes
Changes in heart rate
Assessed every 5 minutes during the procedure
Time frame: 60 minutes
This study is terminated, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Antalya Training and Research Hospital