Postoperative Sore Throat: Interest of the Videolaryngoscope

NCT05614414 | Completed

• 1 other identifier: Sore throat videolaryngoscope
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative sore throat is a complication of orotracheal intubation. The aim of our study was to assess the impact of videolaryngoscopy on postoperative sore throat during the first 24 hours following surgery. This was a prospective, randomized study, over a period of 9 months. The investigators included 136 patients with non-difficult airway, classified ASA I to III and over 18 years old. The patients were randomized into 2 groups: the VL group including 70 patients intubated with direct laryngoscopy and the LD group including 66 patients intubated with videolaryngoscopy.

Conditions

Sore-throat; Anesthesia; Postoperative Pain; Tracheal Intubation Morbidity

Outcome Measures

Primary Outcomes (1)

• Postoperative sore throat

  Postoperative sore throat assessed by verbal scale (from 0 to 10)

  6 hours after surgery

Secondary Outcomes (3)

• Postoperative sore throat

  up to 24 hours after surgery.

• Postoperative dysphonia

  up to 24 hours after surgery

• Postoperative dysphagia

  up to 24 hours after surgery

Study Arms (2)

VL Group

EXPERIMENTAL

Patients who were intubated by videolaryngoscope.

Procedure: tracheal intubation by Videolaryngoscope

LD Group

ACTIVE COMPARATOR

Patients who were intubated by direct laryngoscope

Procedure: tracheal intubation by direct laryngoscope

Interventions

tracheal intubation by Videolaryngoscope PROCEDURE

The investigators performed laryngoscopy using a McGrath video-laryngoscope with a number 4 blade.

VL Group

tracheal intubation by direct laryngoscope PROCEDURE

The investigators performed laryngoscopy using either a Macintosh laryngoscope using a number 4 blade.

LD Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged over 18 years old;
• Patients with ASA status 1, 2 or 3;
• Patients who underwent surgery with general anaesthesia and intubation;
• written consent.

You may not qualify if:

• Patients under corticosteroids;
• Pregnant women;
• Patient with at least two difficult intubation criteria or a limited mouth opening (under 2cm), difficult airway management history, upper airway tumour or cervical rachis trauma;
• Patients who had an otorhinolaryngologic infection in the last month, an intubation or endoscopy of upper airway in the last 48 hours, vomiting in the last 24 hours, a gastric tube in the last 24 hours or throat symptoms prior to surgery;
• Patients scheduled for a surgery implying a manipulation of upper airways;
• Patient scheduled for a surgery \> 2 hours.

Sponsors & Collaborators

• Mongi Slim Hospital: lead

Study Sites (1)

Mongi Slim University Hospital

La Marsa, Tunis Governorate, 2046, Tunisia

Location

MeSH Terms

Conditions

Pharyngitis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: November 14, 2022
• Study Start: January 8, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 31, 2021
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)