Protocol summary

Summary
1-Introduction and background: One of the important complications of tonsillectomy is laryngospasm which leads to airway obstruction, arterial hypoxemia and hypercarbia. 2-Objective: Comparison of the effect of propofol and sodium thiopental as an induction agent on incidence and intensity of laryngospasm after extubation in tonsillectomy. 3- Design: Double blind prospective analytic study (clinical trial), 4- Setting and conduct: 60 paediatric patients who had been scheduled for tonsillectomy were randomly divided into two equal groups. Methods of anesthesia were the same for the two groups except in the induction of anesthesia. One group received sodium thiopental and the other group received propofol. At the end of the operation patients were extubated when they returned to their spontaneous breathing with adequate tidal volume. The occurrence and intensity of laryngospasm were then compared. Inclusion criteria: Childern aged 3 to 12 years old and ASA class 1. Exclusion criteria: 1- History of common cold and sore throat in the 5 weeks prior to the study 2- intubation attempt failed twice or more. (6) Intervention: In control group (Thiopental), for premedication used Diazepam 0.05 mg/kg and Fentanyl 1microgram/kg and atropine 20microgram/kg. For induction of anesthesia in this group used Thiopental 5mg/kg. In the intervention group (propofol), for premedication used Diazepam 0.05 mg/kg and Fentanyl 1microgram/kg and atropine 20 microgram/kg. For induction of anesthesia in this group used Propofol 2.5mg/kg (7) main outcome measure (variables) is laryngospasm

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008164578N1
Registration date: 2010-11-07, 1389/08/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-11-07, 1389/08/16
Registrant information
Name
Farshid Rahimibashar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 811264002151
Email address
f.rahimi@umsh.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin university of medical sciences
Expected recruitment start date
2004-04-20, 1383/02/01
Expected recruitment end date
2004-11-20, 1383/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of propofol and sodium thiopental on post-extubation laryngospasm in patients undergoing tonsillectomy.
Public title
The effect of general anesthesia on tonsillectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Children in 3-12 years old and ASA class 1 exclusion criteria: 1- History of common cold and sore throat in the 5 weeks prior to the study 2- History of corticosteroid usage. 3- The presence of upper and lower respiratory tract infection. 4- The presence of abnormality in the airways. 5- intubation attempt failed twice or more
Age
From 3 years old to 12 years old
Gender
Both
Phase
0
Groups that have been masked
None
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
Bahonar Boulevard, Qazvin University of Medical Sciences -
City
Qazvin
Country
Iran (Islamic Republic of)
Postal code
59811-34197
Approval date
2004-04-13, 1383/01/25
Ethics committee reference number
19

Health conditions studied

1

Description of health condition studied
Enlargment of tonsils
ICD-10 code
J35.1
ICD-10 code description
Hypertrophy of tonsils

2

Description of health condition studied
General Anesthesia in tonsillectomy
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Laryngospasm
Timepoint
Laryngospasm is visualized in the end of surgery and after extubation of patient
Method of measurement
Patient were divided in four groups: 1-without laryngospasm 2-mild laryngospasm 3-moderate laryngospasm4-sever laryngospasm

Secondary outcomes

empty

Intervention groups

1

Description
In control group (Thiopental), for premedication used Diazepam 0.05 mg/kg and Fentanyl 1microgram/kg and atropine 20 microgram/kg. For induction of anaesthesia in this group used Thiopental 5mg/kg
Category
Treatment - Drugs

2

Description
In intervention group (propofol), for premedication used Diazepam 0.05 mg/kg and Fentanyl 1microgram/kg and atropine 20 microgram/kg. For induction of anaesthesia in this group used Propofol 2/5mg/kg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghods hospital
Full name of responsible person
Dr. seyed Abbas Hosseini Jahromi
Street address
Ghods hospital-Shahid Beheshti Blvd-Qazvin
City
Qazvin
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin university of medical sciences-vice chancellor for research
Full name of responsible person
Dr.Saeid Asefzade
Street address
Bahonar Boulevard,
City
Qazvin
Country
Iran (Islamic Republic of)
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-vice chancellor for research
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Seyed Abbas Hosseini Jahromi
Position
Assistant Professor/Anesthesiologist
Other areas of specialty/work
Street address
Shahid Rajaei hospital, end of Garrison Avenue
City
Qazvin
Country
Iran (Islamic Republic of)
Postal code
3413996134
Phone
+98 28 1333 5800
Fax
+98 28 1332 0105
Email
papaya812002@yahoo.com; hosrajaee@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Seyede Masoume Hosseini Valalmi
Position
Assistant Professor/Anesthesiologist
Other areas of specialty/work
Street address
Shahid Rajaei hospital- end of Garrison Avenue
City
Qazvin
Country
Iran (Islamic Republic of)
Postal code
3413996134
Phone
+98 28 1333 5800
Fax
+98 28 1332 0105
Email
parspaya872008@yahoo.com; hosrajaee@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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