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Postoperative Sore Throat: Interest of the Videolaryngoscope

Postoperative Sore Throat: Interest of the Videolaryngoscope

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05614414
Enrollment
135
Registered
2022-11-14
Start date
2021-01-08
Completion date
2021-12-31
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREtracheal intubation by Videolaryngoscope

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

PROCEDUREtracheal intubation by direct laryngoscope

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

Sponsors

Mongi Slim Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative sore throat6 hours after surgeryPostoperative sore throat assessed by verbal scale (from 0 to 10)

Secondary

MeasureTime frameDescription
Postoperative sore throatup to 24 hours after surgery.Postoperative sore throat assessed by verbal scale (from 0 to 10)
Postoperative dysphoniaup to 24 hours after surgeryPresence or no of dysphonia
Postoperative dysphagiaup to 24 hours after surgerypresence or no of dysphagia

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026