Protocol summary

Summary
Airways responses to emergence from general anesthesia are common problems and can result undesirable side effects, such as coughing, laryngospasm and hypertension. The aim of this study was to compare the effect of intratracheal and intravenous lidocaine on bucking, cough and emergence time at the end of anesthesia. Sixty ASA I-II patients received a standard anesthetic. Three minutes before the end of surgery, they were randomly allocated to receive either intravenous lidocaine 1.5mg/kg or intratracheal lidocaine 1.5mg/kg in a double-blind study. The number of bucking and coughs for each patient were continuously monitored for 30 min after extubation. Bucking and coughing were evaluated through a 3-point scale. Heart rate (HR) and Systolic and Diastolic blood pressures (SBP, DBP) were measured before and immediately after tracheal extubation. The emergence time also was recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138810223051N1
Registration date: 2010-06-04, 1389/03/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-04, 1389/03/14
Registrant information
Name
Marzieh Khezri
Name of organization / entity
Qazvine University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1223 6376
Email address
mkhezri@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2009-01-09, 1387/10/20
Expected recruitment end date
2009-06-10, 1388/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intratracheal and intravenous lidocaine on bucking, cough, and emergence time at the end of anesthesia
Public title
Comparison of the effect of intratracheal and intravenous lidocaine on bucking, cough, and emergence time at the end of anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: aged 18 to 60 years, scheduled for elective minor orthopedic surgery, lower abdominal surgery or gynecologic surgery Exclusion criteria: history of laryngeal or tracheal surgery or pathology, bronchial asthma, addiction and smoking., coexisting systemic illness increased intracranial pressure, severe cardiac disease, active upper respiratory tract infections, increased risk for perioperative aspiration of gastric contents, combined epidural/general anesthetic techniques, consumption of cardiovascular medications such as ACE Inhibitors
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Postal code
Approval date
2008-12-29, 1387/10/09
Ethics committee reference number
219

Health conditions studied

1

Description of health condition studied
Airways responses to emergence from general anesthesia
ICD-10 code
Y55.7
ICD-10 code description
Anaesthetic, unspecified

2

Description of health condition studied
the emergence time
ICD-10 code
Y48.4
ICD-10 code description
Anaesthetic, unspecified

Primary outcomes

1

Description
The number of bucking and coughs
Timepoint
before tracheal extubation and thirty minutes after extubation
Method of measurement
bucking and coughing were evaluated on a 3-point scale

2

Description
The emergence time
Timepoint
the time from discontinuation of drugs to extubation of patients at awake condision
Method of measurement
In minutes

Secondary outcomes

1

Description
Heart rate (HR)
Timepoint
immediately after tracheal extubation
Method of measurement
with noninvasive monitoring

2

Description
Systolic blood pressure
Timepoint
immediately after tracheal extubation
Method of measurement
with noninvasive monitoring

3

Description
Diastolic blood pressure
Timepoint
immediately after tracheal extubation
Method of measurement
with noninvasive monitoring

Intervention groups

1

Description
intratracheal lidocaine 1.5 mg/kg
Category
Prevention

2

Description
intravenous lidocaine1.5 mg/kg
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaei hospital
Full name of responsible person
Marzie-beigom Khezri
Street address
City
Qazvin

2

Recruitment center
Name of recruitment center
Kosar hospital
Full name of responsible person
Street address
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzie-beigom Khezri
Street address
Kosar Hospital
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh-beigom Khezri
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Kosar Hospital,
City
Qazvin
Postal code
Phone
+98 28 1223 6375
Fax
Email
mkhezri@qums.ac.irmkhezri88@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh-beigom Khezri
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Kosar Hospital
City
Qazvin
Postal code
Phone
+98 28 1223 6376
Fax
Email
mkhezri@qums.ac.irmkhezri88@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Marzieh-beigom Khezri
Position
Assistant professor of anesthesia
Other areas of specialty/work
Street address
Kosar Hospita
City
Qazvin
Postal code
34188-99579
Phone
+98 28 1223 6375
Fax
+98 28 1223 6378
Email
mkhezri@qums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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