Back to resultsNebulized Lidocaine to Prevent Cough at Emergence From Anesthesia
Primary Purpose
Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat
Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Lidocaine 2%
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat
Eligibility Criteria
Inclusion Criteria:
- age>18 years
- ASA status I or II
Exclusion Criteria:
- Unexpected difficult laryngoscopy
- Surgery>3 hours
Sites / Locations
- Mongi Slim HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
lidocaine group
Placebo group
Arm Description
the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia
the patients of this group will recieve nebulization of 5 ml of normal saline prior to induction of general anesthesia
Outcomes
Primary Outcome Measures
incidence of cough at emergence from general anesthesia
evaluation of incidence of cough at emergence from general anesthesia
Secondary Outcome Measures
incidence of sore throat
evaluation of incidence of sore throat
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04000633
Brief Title
Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia
Official Title
Nebulized Lidocaine Versus Placebo to Prevent Cough at Emergence From Anesthesia: a Double Blind Prospective Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mongi Slim Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, General Anesthesia, Extubation, Lidocaine, Sore Throat
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups comparaison between nebulized lidocaine versus placebo for prevention of cough at emergence from general anesthesia and post extubation sore throat
Masking
ParticipantCare Provider
Masking Description
The investigator will provide to the anesthesiologist 1 seringue containing either lidocaine or normal saline to be nebulized before induction of general anesthesia
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lidocaine group
Arm Type
Active Comparator
Arm Description
the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
the patients of this group will recieve nebulization of 5 ml of normal saline prior to induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2%
Intervention Description
the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
incidence of cough at emergence from general anesthesia
Description
evaluation of incidence of cough at emergence from general anesthesia
Time Frame
30 minutes after the end of surgery
Secondary Outcome Measure Information:
Title
incidence of sore throat
Description
evaluation of incidence of sore throat
Time Frame
24 hours after tracheal extubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age>18 years
ASA status I or II
Exclusion Criteria:
Unexpected difficult laryngoscopy
Surgery>3 hours
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mhamed Sami Mebazaa, professor
Phone
0021622252589
Email
msmebazaa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hajer Arfaoui
Phone
0021699336661
Email
hejer_arfaoui@hotmail.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mhamed Sami Mebazaa, Professor
Organizational Affiliation
Mongi Slim Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mongi Slim Hospital
City
La Marsa
State/Province
Tunis
ZIP/Postal Code
2046
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mhamed Sami Mebazaa, professor
Phone
0021622252589
Email
msmebazaa@gmail.com
First Name & Middle Initial & Last Name & Degree
Asma Ben Souissi, Ass Prof
Phone
0021698336883
Email
bsouissiasma@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nebulized Lidocaine to Prevent Cough at Emergence From Anesthesia
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