Postoperative Sore Throat: Interest of the Videolaryngoscope

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Anesthesia; Tracheal Intubation Morbidity; Sore-throat
• Intervention / Treatment: Procedure: tracheal intubation by Videolaryngoscope; Procedure: tracheal intubation by direct laryngoscope

Detailed Description

The investigators monitored blood pressure, ECG, saturation in oxygen, capnograph, temperature and curarization. They also monitored cuff pressure using manometer.

The investigators pre-oxygenated the patients until the fractional expired oxygen was over 90%, then induced anaesthesia using either 2.5 to 3.5 mg/kg of propofol or 0.3 to 0.4 mg/kg of etomidate, then 1mg/kg of suxamethonium (in absence of contraindication). If modified crash induction was performed, the anaesthesiologist mentioned the opioid used.

The investigators performed laryngoscopy using either a Macintosh laryngoscope using a number 4 blade in LD group, or a McGrath video-laryngoscope with a number 4 blade in VL group and a stylet when needed. Women were intubated using number 7 tube and man using a 7.5 tube. They inflated the cuff with 7ml of air, and controlled pressure by manometer every 30 minutes in order to maintain it between 20 and 25 mmHg.

The investigators ventilated patients with assisted controlled mode using a 6ml/kg of ideal weight volume, a 6 mmHg PEEP, a 50% inspired fraction of oxygen and a respiratory rate guaranteeing an end-expiratory CO2 level between 35 and 40 mmHg. Then, they administrated 4 mg of Ondansetran in order to prevent postoperative nausea and vomiting (PONV).

The investigators maintained anaesthesia using either isoflurane or sevoflurane, 0.1 μg/kg of sufentanil and 0.05 mg/kg of atracurium.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Tunis
    • La Marsa, Tunis, Tunisia, 2046
      • Mongi Slim University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VL Group; Patients who were intubated by videolaryngoscope.	Procedure: tracheal intubation by Videolaryngoscope; The investigators performed laryngoscopy using a McGrath video-laryngoscope with a number 4 blade.
ACTIVE_COMPARATOR: LD Group; Patients who were intubated by direct laryngoscope	Procedure: tracheal intubation by direct laryngoscope; The investigators performed laryngoscopy using either a Macintosh laryngoscope using a number 4 blade.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative sore throat	Postoperative sore throat assessed by verbal scale (from 0 to 10)	6 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative sore throat	Postoperative sore throat assessed by verbal scale (from 0 to 10)	up to 24 hours after surgery.
Postoperative dysphonia	Presence or no of dysphonia	up to 24 hours after surgery
Postoperative dysphagia	presence or no of dysphagia	up to 24 hours after surgery

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 8, 2021
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: October 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (ACTUAL): November 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis
• Other Study ID Numbers: Sore throat videolaryngoscope

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No