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Effect of Lidocaine 1% and 2% in the Tube Cuff on Postoperative Sore Throat and Cough

Effect of Lidocaine 1% and 2% in the Endotracheal Tube Cuff on Postoperative Sore Throat and Cough

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03792776
Acronym
ELIT
Enrollment
150
Registered
2019-01-03
Start date
2019-01-31
Completion date
2020-10-31
Last updated
2019-01-15

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

Conditions

Postoperative Cough, Postoperative Sore Throat

Keywords

Lidocaine 1%, Lidocaine 2%, Endotracheal tube cuff, Cuff inflation, Postoperative sore throat, Postoperative cough, General anesthesia, Endotracheal intubation

Brief 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%).

Detailed 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.

Interventions

OTHERcuff inflation with air

Endotracheal tube cuff inflation with air

DRUGcuff inflation with lidocaine 1%

Endotracheal tube cuff inflation with lidocaine 1%

DRUGcuff inflation with lidocaine 2%

Endotracheal tube cuff inflation with lidocaine 2%

OTHERInduction 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 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).

OTHEREndotracheal 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).

OTHERSystematic post-operative analgesia

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

Sponsors

Ogarite Habib
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sore throat intensity 0hour 0 after extubationThroat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Sore throat intensity 2at 2 hours after extubationThroat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Sore throat intensity 6at 6 hours after extubationThroat pain evaluation using the visual analog scale of pain (range from 0 cm (no pain) to 10 cm (very intense pain))
Sore throat intensity 24at 24 hours after extubationThroat pain evaluation using the visual analog scale of pain (range: from 0 cm (no pain) to 10 cm (very intense pain))
Cough intensity 0hour 0 after extubationCough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 2at 2 hours after extubationCough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 6at 6 hours after extubationCough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))
Cough intensity 24at 24 hours after extubationCough intensity evaluation using the visual analog scale of cough (range from 0 cm (no cough) to 10 cm (very severe cough))

Contacts

Primary ContactOgarite P Habib, MD
Ogarite.habib@hotmail.com+9613722518

Outcome results

None listed

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