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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03792776
Other study ID # CEHDF 1263
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2019
Est. completion date October 2020

Study information

Verified date January 2019
Source Saint-Joseph University
Contact Ogarite P Habib, MD
Phone +9613722518
Email Ogarite.habib@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparing the effect of different methods of endotracheal tube cuff inflation on the occurrence of a postoperative sore throat and cough (Air vs Lidocaine 1% vs Lidocaine 2%).


Description:

Eligible patients undergoing general anesthesia will be randomized and assigned to three groups:

Group A: Endotracheal tube cuff inflation with air Group B: Endotracheal tube cuff inflation with Lidocaine 1% Group C: Endotracheal tube cuff inflation with Lidocaine 2%

The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.

Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).

The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O).

The volume of lidocaine used will never exceed 5 mg / kg for the patient to be protected from the local toxicity of the local anesthetic in case of accidental rupture of the balloon.

All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date October 2020
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients over 18 years old

- American Society of Anesthesiologists classification (ASA) category 1 or 2

- High pressure, low volume endotracheal tube - (Lo-pro)

Exclusion Criteria:

- Ear nose and throat and cranial surgery

- Ear nose and throat pathologies

- Asthma and bronchial hyperreactivity

- Chronic cough

- Diabetes

- Cognitive disorders

- Swallowing disorders

- Corticotherapy during the last week

- Allergy to lidocaine

- Urgent surgery

- Nasogastric, oro-gastric

- Ventral position

- More than 2 intubation attempts

- Continuous intravenous infusion of lidocaine intraoperatively.

Study Design


Intervention

Other:
cuff inflation with air
Endotracheal tube cuff inflation with air
Drug:
cuff inflation with lidocaine 1%
Endotracheal tube cuff inflation with lidocaine 1%
cuff inflation with lidocaine 2%
Endotracheal tube cuff inflation with lidocaine 2%
Other:
Induction of anesthesia
The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.
Maintenance of anesthesia
Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).
Endotracheal intubation
The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O).
Systematic post-operative analgesia
All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ogarite Habib

Outcome

Type Measure Description Time frame Safety issue
Primary Sore throat intensity 0 Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain)) hour 0 after extubation
Primary Sore throat intensity 2 Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain)) at 2 hours after extubation
Primary Sore throat intensity 6 Throat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain)) at 6 hours after extubation
Primary Sore throat intensity 24 Throat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain)) at 24 hours after extubation
Primary Cough intensity 0 Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough)) hour 0 after extubation
Primary Cough intensity 2 Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough)) at 2 hours after extubation
Primary Cough intensity 6 Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough)) at 6 hours after extubation
Primary Cough intensity 24 Cough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough)) at 24 hours after extubation
See also
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Recruiting NCT06266481 - Topical Dexamethasone Versus Topical Lidocaine Spray to Reduce POST in Shoulder Arthroscopic Surgeries: A Comparative Study Phase 2/Phase 3
Recruiting NCT05436743 - Efficacy of K-Y Jelly in Prevention of Postoperative Sore Throat After Nasal Surgery Phase 4
Recruiting NCT06218836 - Effect of Inflated Versus Non-inflated Endotracheal Tube on Sore Throat N/A
Completed NCT04371094 - Sore Throat After Intubation Using Glidescope With Stylet and Bougie N/A
Enrolling by invitation NCT04644900 - Effect of Chewing Gum and Mouthwash Before Operation on Sore Throat After General Anesthesia With a Laryngeal Mask N/A
Active, not recruiting NCT06122324 - Effect of Lidocaine on Hemodynamic Response and Postoperative Sore Throat
Completed NCT02492646 - Effect of Saline Lubrication on Post-intubation Complications N/A
Recruiting NCT05825872 - Ultrasound-Guided Internal Superior Laryngeal Nerve Block for Double-Lumen Bronchial Tube Phase 4
Not yet recruiting NCT06368843 - the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat