Clincosm LogoSign in Get a demo

Postoperative Sore Throat: Interest of the Videolaryngoscope

Sponsor
Mongi Slim Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05614414
Collaborator
(none)
135
Enrollment
1
Location
2
Arms
11.7
Actual Duration (Months)
11.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: tracheal intubation by Videolaryngoscope
  • Procedure: tracheal intubation by direct laryngoscope
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Postoperative Sore Throat: Interest of the Videolaryngoscope
Actual Study Start Date :
Jan 8, 2021
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Postoperative sore throat [6 hours after surgery]

    Postoperative sore throat assessed by verbal scale (from 0 to 10)

Secondary Outcome Measures

  1. Postoperative sore throat [up to 24 hours after surgery.]

    Postoperative sore throat assessed by verbal scale (from 0 to 10)

  2. Postoperative dysphonia [up to 24 hours after surgery]

    Presence or no of dysphonia

  3. Postoperative dysphagia [up to 24 hours after surgery]

    presence or no of dysphagia

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mongi Slim University Hospital La Marsa Tunis Tunisia 2046

Sponsors and Collaborators

  • Mongi Slim Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mhamed Sami Mebazaa, Professor, Mongi Slim Hospital
ClinicalTrials.gov Identifier:
NCT05614414
Other Study ID Numbers:
  • Sore throat videolaryngoscope
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pharyngitis

Study Results

No Results Posted as of Nov 14, 2022