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Postoperative Sore Throat: Interest of the Videolaryngoscope

Primary Purpose

Sore-throat, Anesthesia, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
tracheal intubation by Videolaryngoscope
tracheal intubation by direct laryngoscope
Sponsored by
Mongi Slim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sore-throat

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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.

Sites / Locations

  • Mongi Slim University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VL Group

LD Group

Arm Description

Patients who were intubated by videolaryngoscope.

Patients who were intubated by direct laryngoscope

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative sore throat
Postoperative sore throat assessed by verbal scale (from 0 to 10)
Postoperative dysphonia
Presence or no of dysphonia
Postoperative dysphagia
presence or no of dysphagia

Full Information

First Posted
October 7, 2022
Last Updated
November 7, 2022
Sponsor
Mongi Slim Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05614414
Brief Title
Postoperative Sore Throat: Interest of the Videolaryngoscope
Official Title
Postoperative Sore Throat: Interest of the Videolaryngoscope
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mongi Slim Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore-throat, Anesthesia, Postoperative Pain, Tracheal Intubation Morbidity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VL Group
Arm Type
Experimental
Arm Description
Patients who were intubated by videolaryngoscope.
Arm Title
LD Group
Arm Type
Active Comparator
Arm Description
Patients who were intubated by direct laryngoscope
Intervention Type
Procedure
Intervention Name(s)
tracheal intubation by Videolaryngoscope
Intervention Description
The investigators performed laryngoscopy using a McGrath video-laryngoscope with a number 4 blade.
Intervention Type
Procedure
Intervention Name(s)
tracheal intubation by direct laryngoscope
Intervention Description
The investigators performed laryngoscopy using either a Macintosh laryngoscope using a number 4 blade.
Primary Outcome Measure Information:
Title
Postoperative sore throat
Description
Postoperative sore throat assessed by verbal scale (from 0 to 10)
Time Frame
6 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative sore throat
Description
Postoperative sore throat assessed by verbal scale (from 0 to 10)
Time Frame
up to 24 hours after surgery.
Title
Postoperative dysphonia
Description
Presence or no of dysphonia
Time Frame
up to 24 hours after surgery
Title
Postoperative dysphagia
Description
presence or no of dysphagia
Time Frame
up to 24 hours after surgery

10. Eligibility

Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Mongi Slim University Hospital
City
La Marsa
State/Province
Tunis
ZIP/Postal Code
2046
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Sore Throat: Interest of the Videolaryngoscope

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