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

NCT ID: NCT03792776

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-31

Study Completion Date

2020-10-31

Brief Summary

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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

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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.

Conditions

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Postoperative Sore Throat Postoperative Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Air

Endotracheal tube cuff inflation with air

Group Type ACTIVE_COMPARATOR

cuff inflation with air

Intervention Type OTHER

Endotracheal tube cuff inflation with air

Induction of anesthesia

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Lidocaine 1%

Endotracheal tube cuff inflation with Lidocaine 1%

Group Type EXPERIMENTAL

cuff inflation with lidocaine 1%

Intervention Type DRUG

Endotracheal tube cuff inflation with lidocaine 1%

Induction of anesthesia

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Lidocaine 2%

Endotracheal tube cuff inflation with Lidocaine 2%

Group Type EXPERIMENTAL

cuff inflation with lidocaine 2%

Intervention Type DRUG

Endotracheal tube cuff inflation with lidocaine 2%

Induction of anesthesia

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Interventions

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cuff inflation with air

Endotracheal tube cuff inflation with air

Intervention Type OTHER

cuff inflation with lidocaine 1%

Endotracheal tube cuff inflation with lidocaine 1%

Intervention Type DRUG

cuff inflation with lidocaine 2%

Endotracheal tube cuff inflation with lidocaine 2%

Intervention Type DRUG

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.

Intervention Type OTHER

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).

Intervention Type OTHER

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).

Intervention Type OTHER

Systematic post-operative analgesia

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ogarite Habib

OTHER

Sponsor Role lead

Responsible Party

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Ogarite Habib

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hicham Jabbour, MD

Role: STUDY_DIRECTOR

Saint JU

Central Contacts

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Ogarite P Habib, MD

Role: CONTACT

+9613722518

Other Identifiers

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CEHDF 1263

Identifier Type: -

Identifier Source: org_study_id

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