The aim of this study was to compare the effects of hydrocortisone and dexamethasone prior to extubation laryngospasm, coughing and stridor after general anesthesia. This is Clinical Trial, double-blind study with 108 patients, aged 15-55 years in hospital operating rooms of 15 Khordad in Bidokht and Hasheminejad in Mashhad. Patients class 1 and 2 ASA undergoing elective surgery (orthopedics, general surgery and urology) under anesthesia intwo groups, Dexamethasone and hydrocortisone with intubation. Procedure to induce anesthesia in both fixed as premedication with midazolam 1-2mg, fentanyl 1-2 mcg / kg and induction of anesthesia with thiopental 5 mg / kg, neuromuscular./5 mg / kg. The endotracheal tube cuff pressure to the extent that is not commensurate with the size and sex of patients Leakage will be selected. Group 1 and group 2 hydrocortisone100 mg and dexamethasone 8 mg An intravenous dose 30 minutes before extubation receive back after swallowing reflex of the patient extubation laryngospasm, cough, stridor and the results of the questionnaire survey reflected.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015032520838N1
Registration date:2015-03-25, 1394/01/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-25, 1394/01/05
Registrant information
Name
Massoume Heidary karizaki
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51138679737
Email address
heidarykm1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Gonabad University of Medical Sciences
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of intravenous hydrocortisone and dexamethasone before extubation on Laryngospasm, cough and stridor after general anesthesia
Public title
Comparison the effects of intravenous hydrocortisone and dexamethasone before extubation on Laryngospasm, cough and stridor after general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients candidate for elective orthopedic surgery; general surgery and urology under general anesthesia with tracheal intubation ASA1,2 class in the age group 15- 55 years; Surgery less than 2 hours.
Exclusion criteria: Larynx surgery;Respiratory disease; Difficult intubation; Require prolonged endotracheal intubation; Drug abuse.
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
N/A
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
Gonabad University of Medical Sciences
Street address
Next to the Asian road, Gonabad, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Approval date
2015-01-07, 1393/10/17
Ethics committee reference number
GMU.REC.1393.95
Health conditions studied
1
Description of health condition studied
Stridor
ICD-10 code
j38.4
ICD-10 code description
Oedema of larynx
2
Description of health condition studied
Laryngospasm - Cough
ICD-10 code
J95.8
ICD-10 code description
Post procedural respiratory disorders
Primary outcomes
1
Description
Laryngospasm
Timepoint
Afte extubation
Method of measurement
Clinical signs and score table laryngospasm
2
Description
Cough
Timepoint
After extubation
Method of measurement
Clinical signs on the score sheet cough
3
Description
Stridor
Timepoint
After extubation
Method of measurement
Clinical signs and stridor score table
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: Hydrocortisone 100 mg IV 30 minutes before to extubation
Category
Treatment - Drugs
2
Description
Group 2: Dexamethasone 100 mg IV 30 minutes before to extubation
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
15 Khordad Hospital, Bidokht, Gonabad and Shahid Hasheminejad Hospital Mashhad
Full name of responsible person
Massoume Heidary Karizaki
Street address
Shahid Hasheminejad Hospital, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadpour
Street address
Gonabad University of Medical Sciences
City
Gonabad
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Mahdi Basiri
Position
MSc. in Critical Care Nursing
Other areas of specialty/work
Street address
Next to the Asian road, Gonabad, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+51 57 225813
Fax
+98 515723116
Email
basiri1344@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Arash Hamzei
Position
Anesthesiologist
Other areas of specialty/work
Street address
Next to the Asian road, Gonabad, Gonabad University of Medical Sciences
City
Gonabad
Postal code
Phone
+98 515723113
Fax
+98 515723116
Email
arash_hamzei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Massoume Heidary Karizaki
Position
Student in Critical Care Nursing
Other areas of specialty/work
Street address
Shahid Hasheminejad hospital, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3270 6606
Fax
Email
heidarykm1@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)