Coughing is one of the major complications during emergence from general anesthesia. Severe coughing during emergence from anesthesia may cause laryngospasm and bronchospasm in patients. In this study, patients will be randomly assigned to one of two groups: propofol and ketamine. At the end of surgery, by stopping anesthetic drugs, we will allow spontaneous respiration of patients will return. After that, patients in the 1st group will be received intravenous propofol 0.5mg/kg and in the 2st group, patients will be received intravenous ketamine 0.5mg.kg/Kg. After extubation, the number of cough, the amount of pain and agitation, as well as nausea and vomiting the patients will be evaluated by a nurse of anesthesia who is unaware of the patient's drug, until they leave the recovery room.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016101411662N11
Registration date:2017-08-20, 1396/05/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
sahmeddini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University Of Medical Sciences .
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of propofol and ketamine on the incidence of emergence cough in children undergoing Tonsillectomy.
Public title
Comparison the effect of propofol and ketamine on the incidence of emergence cough
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria: All patients whom will be candidate for Tonsillectomy, Age 3 to 12 years.
The exclusion criteria: Patients are not in ASA class I and II;
The patients has abnormalities in face or upper airway such as (maxillofacial fractures, tumors); Patients with respiratory problems like asthma; Allergic patients, those who have behavioral problems that needs to use sedative drugs before entering the operating room; patients who have cough due to any cause before surgery and the patients refuse to enter the study.
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Shiraz Medical School Research Ethic Committee
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Postal code
197871345
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.sums.med.rec.1396.52
Health conditions studied
1
Description of health condition studied
Cough following tonsillectomy
ICD-10 code
R05
ICD-10 code description
Pain in throat
Primary outcomes
1
Description
Postoperative cough
Timepoint
30 minutes -2- 4 -8 -12 -24 hours post operation
Method of measurement
Questioners: Number of postoperative cough will be registered
Secondary outcomes
1
Description
Postoperative pain and agitation
Timepoint
30 minutes,2, 4 ,8 ,12 and 24 hours post operation.
Method of measurement
Questioners: CHEOPS and Richmond
2
Description
Nausea and Vomiting
Timepoint
30 minutes,2, 4 ,8 ,12 and 24 hours post operation.
Method of measurement
Questioners
Intervention groups
1
Description
After spontaneous respiratory will be returned, patients in the 1st group received intravenous propofol.
Category
Treatment - Drugs
2
Description
In the second group after spontaneous respiration will be returned, patients will be received intravenous ketamin.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dastghaib Training and Medical Center
Full name of responsible person
MohammaAli Sahmeddini
Street address
Hafez Avenue
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology
Full name of responsible person
Seyed Basir Hashemi
Street address
Shiraz University Of Medical Sciences building, Zand Blvd.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology
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
Shiraz University Of Medical Sciences
Full name of responsible person
MohammadAli Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddin@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
MohammadAli Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddin@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
MohammadAli Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddin@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)