Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia

NCT ID: NCT04000633

Last Updated: 2019-06-27

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-12-31

Brief Summary

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our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.

Detailed Description

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our study aimed to evaluate the effect of nebulized lidocaine to decrease the incidence of cough and sore throat after extubation after surgeries requiring endotracheal intubation.

This randomized controlled study will compare the effect of Lidocaine and placebo nebulization in the immediate pre operative period in order to evaluate the effectiveness in reducing post extubation cough and sore throat.

Conditions

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Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups comparaison between nebulized lidocaine versus placebo for prevention of cough at emergence from general anesthesia and post extubation sore throat
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers
The investigator will provide to the anesthesiologist 1 seringue containing either lidocaine or normal saline to be nebulized before induction of general anesthesia

Study Groups

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lidocaine group

the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia

Group Type ACTIVE_COMPARATOR

Lidocaine 2%

Intervention Type DRUG

the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia

Placebo group

the patients of this group will recieve nebulization of 5 ml of normal saline prior to induction of general anesthesia

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline

Interventions

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Lidocaine 2%

the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia

Intervention Type DRUG

Normal saline

Normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age\>18 years
* ASA status I or II

Exclusion Criteria

* Unexpected difficult laryngoscopy
* Surgery\>3 hours
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mongi Slim Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mhamed Sami Mebazaa

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mhamed Sami Mebazaa, Professor

Role: PRINCIPAL_INVESTIGATOR

Mongi Slim Hospital

Locations

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Mongi Slim Hospital

La Marsa, Tunis Governorate, Tunisia

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Mhamed Sami Mebazaa, professor

Role: CONTACT

0021622252589

Hajer Arfaoui

Role: CONTACT

0021699336661

Facility Contacts

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Mhamed Sami Mebazaa, professor

Role: primary

0021622252589

Asma Ben Souissi, Ass Prof

Role: backup

0021698336883

Other Identifiers

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lidocaïne cough prevention

Identifier Type: -

Identifier Source: org_study_id

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