A comparison of effect of pretreatment with intravenous dexamethasone, intravenous ketamine and their combination for suppression of remifentanil induced cough: a randomized, double-blind, placebo controlled clinical trial
The injection of remifentanil can cause cough during induction of anesthesia. This study was designed to examine the efficacy of ketamine, dexamethasone and their combination on remifentanil-induced cough (RIC).
One hundred twenty patients scheduled for elective surgery were randomly assigned into four groups: Group K received 10 mg ketamine; Group D received 10 mg dexamethasone; Group KD received 10 mg ketamine in combination with dexamethasone; Group S received saline in similar volume five minutes prior to the injection of remifentanil .The incidence and severity of coughs were recorded in each person.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210255362N4
Registration date:2012-11-11, 1391/08/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-11, 1391/08/21
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of effect of pretreatment with intravenous dexamethasone, intravenous ketamine and their combination for suppression of remifentanil induced cough: a randomized, double-blind, placebo controlled clinical trial
Public title
A comparison of effect of pretreatment with intravenous dexamethasone, intravenous ketamine and their combination for suppression of remifentanil induced cough
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: patient satisfaction to enter study; body weight less than 20% of ideal body weight; no history of smoking, chronic obstructive lung diseases, bronchial asthma, respiratory tract infection or allergy to the study drugs; treated with angiotensin converting enzyme inhibitor, bronchodilators or steroid
Exclusion criteria: any changes in anesthesia technique
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
8174675731
Approval date
2011-11-05, 1390/08/14
Ethics committee reference number
391239
Health conditions studied
1
Description of health condition studied
cough
ICD-10 code
R05
ICD-10 code description
cough
Primary outcomes
1
Description
Severity of cough
Timepoint
5 minute After injection of remifentanil
Method of measurement
counting
2
Description
Incidence of cough
Timepoint
5 minute After injection of remifentanil
Method of measurement
watch
3
Description
onset time of cough
Timepoint
5 minute After injection of remifentanil
Method of measurement
watch
Secondary outcomes
1
Description
Haemodynamic
Timepoint
immediately after arriving at operation room,immediately after injection of remifentanil,immediately after injection of tiopantal
Method of measurement
watch
2
Description
side effect
Timepoint
every hour
Method of measurement
watch
Intervention groups
1
Description
Group ketamine: 10 mg of ketamine in 3ml volume+3 ml saline was injected.
Category
Prevention
2
Description
Group saline: the same volume of saline was injected .
Category
Prevention
3
Description
Group combination of ketamine and dexamethasone: 10 mg of combination of ketamine and dexamethasone in 3ml volume+3 ml saline was injected.
Category
Prevention
4
Description
Group dexamethasone:10 mg of dexamethasone in 3ml volume+3 ml saline was injected .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Dr. Mohammadreza Safavi
Street address
Kashani street, Isfahan, Iran
City
Iisfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Azim Honarmand
Street address
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, I
Full name of responsible person
Dr. Mohammadreza Safavi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
8174675731
Phone
+98 31 1625 5555
Fax
+98 31 1273 2659
Email
safavi@med.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, I
Full name of responsible person
Dr. Azim Honarmand
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
8174675731
Phone
+98 31 1273 2659
Fax
+98 31 1236 1594
Email
honarmand@med.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, I
Full name of responsible person
Mohammadreza Safavi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
8174675731
Phone
+98 31 1273 2659
Fax
+98 31 1273 2659
Email
safavi@med.mui.ac.ir
Web page address
www.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)