Sore-throatNCT05614414
Postoperative Sore Throat: Interest of the Videolaryngoscope
A study testing tracheal intubation by Videolaryngoscope and tracheal intubation by direct laryngoscope in people with Sore-throat and Anesthesia, run by Mongi Slim Hospital at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sore-throat, Anesthesia, Postoperative Pain
- What is being tested?
- tracheal intubation by Videolaryngoscope and tracheal intubation by direct laryngoscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteTunisia
- Study dates
- 8 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Mongi Slim University Hospital
La Marsa, Tunis Governorate, 2046
About this study
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.
Read the 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.
- Being tested
- tracheal intubation by Videolaryngoscope, tracheal intubation by direct laryngoscope
- Medical subject headings
- Pharyngitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheal intubation by VideolaryngoscopeProcedure or surgery
The investigators performed laryngoscopy using a McGrath video-laryngoscope with a number 4 blade.
tracheal intubation by direct laryngoscopeProcedure or surgery
The investigators performed laryngoscopy using either a Macintosh laryngoscope using a number 4 blade.
| Study group | Role | What they receive |
|---|---|---|
| VL Group | Experimental | Patients who were intubated by videolaryngoscope. Receives: Procedure: tracheal intubation by Videolaryngoscope |
| LD Group | Active comparator | Patients who were intubated by direct laryngoscope Receives: Procedure: tracheal intubation by direct laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative sore throat
Postoperative sore throat assessed by verbal scale (from 0 to 10)
Measured: 6 hours after surgery
Secondary outcomes (3)
Postoperative sore throat
Postoperative sore throat assessed by verbal scale (from 0 to 10)
Measured: up to 24 hours after surgery.
Postoperative dysphonia
Presence or no of dysphonia
Measured: up to 24 hours after surgery
Postoperative dysphagia
presence or no of dysphagia
Measured: up to 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start8 Jan 2021
- Primary completion30 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sore-throatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614414
- Sponsor's protocol ID
- Sore throat videolaryngoscope
- Status last verified
- Nov 2022
- First submitted
- 7 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Sore Throat: Interest of the Videolaryngoscope
- ClinicalTrials.gov ID
- NCT05614414
- Acronym / sponsor ID
- Sore throat videolaryngoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VL Group | Experimental | Procedure: tracheal intubation by VideolaryngoscopePatients who were intubated by videolaryngoscope. |
| LD Group | Active comparator | Procedure: tracheal intubation by direct laryngoscopePatients who were intubated by direct laryngoscope |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tracheal intubation by VideolaryngoscopeThe investigators performed laryngoscopy using a McGrath video-laryngoscope with a number 4 blade. | Procedure or surgery | VL Group |
| tracheal intubation by direct laryngoscopeThe investigators performed laryngoscopy using either a Macintosh laryngoscope using a number 4 blade. | Procedure or surgery | LD Group |
Primary outcome
Postoperative sore throat
Time frame: 6 hours after surgery
Postoperative sore throat assessed by verbal scale (from 0 to 10)
3 secondary outcomes
Postoperative sore throat
Time frame: up to 24 hours after surgery.
Postoperative dysphonia
Time frame: up to 24 hours after surgery
Postoperative dysphagia
Time frame: up to 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tracheal intubation by Videolaryngoscope and tracheal intubation by direct laryngoscope in people with Sore-throat and Anesthesia, run by Mongi Slim Hospital at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative sore throat (time frame: 6 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.