Postoperative Sore Throat: Interest of the Videolaryngoscope

NCT ID: NCT05614414

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-08
• Study Completion Date: 2021-12-31

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

VL Group

Patients who were intubated by videolaryngoscope.

Group Type: EXPERIMENTAL

tracheal intubation by Videolaryngoscope

Intervention Type: PROCEDURE

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

LD Group

Patients who were intubated by direct laryngoscope

Group Type: ACTIVE_COMPARATOR

tracheal intubation by direct laryngoscope

Intervention Type: PROCEDURE

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

Interventions

tracheal intubation by Videolaryngoscope

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

Intervention Type: PROCEDURE

tracheal intubation by direct laryngoscope

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Accepts Healthy Volunteers: No

Sponsors

Mongi Slim Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mhamed Sami Mebazaa

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mongi Slim University Hospital

La Marsa, Tunis Governorate, Tunisia

Countries

Tunisia

Other Identifiers

Sore throat videolaryngoscope

Identifier Type: -

Identifier Source: org_study_id