Postoperative Sore Throat: Interest of the Videolaryngoscope

Postoperative Pain Clinical Trial

Official title:

Postoperative Sore Throat: Interest of the Videolaryngoscope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05614414
• Other study ID #: Sore throat videolaryngoscope
• Status: Completed
• Phase: N/A
• Start date: January 8, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2022
• Source: Mongi Slim Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Pharyngitis
• Postoperative Pain
• Tracheal Intubation Morbidity

Intervention

Procedure:
• tracheal intubation by Videolaryngoscope
The investigators performed laryngoscopy using a McGrath video-laryngoscope with a number 4 blade.
• tracheal intubation by direct laryngoscope
The investigators performed laryngoscopy using either a Macintosh laryngoscope using a number 4 blade.

Locations

Country	Name	City	State
Tunisia	Mongi Slim University Hospital	La Marsa	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative sore throat	Postoperative sore throat assessed by verbal scale (from 0 to 10)	6 hours after surgery
Secondary	Postoperative sore throat	Postoperative sore throat assessed by verbal scale (from 0 to 10)	up to 24 hours after surgery.
Secondary	Postoperative dysphonia	Presence or no of dysphonia	up to 24 hours after surgery
Secondary	Postoperative dysphagia	presence or no of dysphagia	up to 24 hours after surgery