Effect of Nebulized Lidocaine on Postoperative Sore Throat

NCT03779516 | Terminated

• 1 other identifier: AntalyaTRH 28
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Sore Throat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• whether the hoarseness was present or not

  24 hours

• Intraoperative opioid consumption

  60 minutes

• Postoperative analgesic consumption

  24 hours

• Changes in mean arterial pressure

  60 minutes

• Changes in heart rate

  60 minutes

Study Arms (2)

Group C

ACTIVE COMPARATOR

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

Group L

ACTIVE COMPARATOR

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

Interventions

Saline OTHER

Effect of saline on postoperative sore throat

Group C

Lidocaine OTHER

Effect of nebulized lidocaine on postoperative sore throat

Group L

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Sodium Chloride; Lidocaine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: December 19, 2018
• Primary Completion: April 22, 2019
• Study Completion: July 15, 2019
• Last Updated: April 30, 2020

Record last verified: 2018-12

Locations

TU (1)