Clinical trial NCT05614414: Postoperative Sore Throat: Interest of the Videolaryngoscope
Official title: Postoperative Sore Throat: Interest of the Videolaryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sore-throat
Anesthesia
Postoperative Pain
Tracheal Intubation Morbidity
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 135
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Postoperative sore throat
timeFrame: 6 hours after surgery
Secondary outcomes:
measure: Postoperative sore throat
timeFrame: up to 24 hours after surgery.
measure: Postoperative dysphonia
timeFrame: up to 24 hours after surgery
measure: Postoperative dysphagia
timeFrame: up to 24 hours after surgery
Other outcomes:
Locations:
city: La Marsa
country: Tunisia
facility: Mongi Slim University Hospital
state: Tunis
Study officials:
References: