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Effect of Nebulized Lidocaine on Postoperative Sore Throat

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03779516
Enrollment
110
Registered
2018-12-19
Start date
2018-12-19
Completion date
2019-07-15
Last updated
2020-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sore Throat

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.

Interventions

OTHERSaline

Effect of saline on postoperative sore throat

OTHERLidocaine

Effect of nebulized lidocaine on postoperative sore throat

Sponsors

Antalya Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in the incidence of postoperative sore throat24 hoursSore 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

MeasureTime frameDescription
whether the hoarseness was present or not24 hoursHoarseness 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 consumption60 minutesAssessed in intraoperative period
Postoperative analgesic consumption24 hoursAssessed in postoperative period
Changes in mean arterial pressure60 minutesAssessed every 5 minutes during the procedure
Changes in heart rate60 minutesAssessed every 5 minutes during the procedure

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026