determining the effect of two different dose of ketamine gargling on the incidence and severity of postoperative sore throat.
Design
double blind, randomized controlled trial
Settings and conduct
After obtaining written informed consent, 96 patients were assigned to 3 groups equally by computer based block design random allocation. Group K received 50 mg Ketamine solved in 29 ml saline, group G received 100 mg Ketamine solved in 28 ml saline and group C received 30 ml saline as control group. 30 ml of these prepared solutions spilled in the same opaque containers and were given to patients by a nurse to gargle for 30 seconds 5 minutes prior to intubation. This nurse didn't have any more roll during the study. Patients couldn't be unaware about the prepared solutions due to different flavors of them.
Participants/Inclusion and exclusion criteria
inclusion criteria: class I and II American Society of Anesthesiologists (ASA) classification system, age range of 18-65 years old, candidates of elective Septo-plasty surgery with general anesthesia, no pre-operative sore throat, no asthma and no sensitivity to using drugs.
Exclusion criteria include: try for ET intubation more than one time and change of anesthetic technique.
Intervention groups
1- 50 mg Ketamine solved in 29 ml saline.
2- 100 mg Ketamine solved in 28 ml saline
Main outcome variables
Post- operative sore throat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101211005362N22
Registration date:2018-09-17, 1397/06/26
Registration timing:retrospective
Last update:2018-09-17, 1397/06/26
Update count:1
Registration date
2018-09-17, 1397/06/26
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
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
2018-08-03, 1397/05/12
Actual recruitment end date
2018-08-21, 1397/05/30
Trial completion date
empty
Scientific title
Prophylactic effects of Ketamine gargle on post-operative sore throat: A double blinded randomized controlled trial
Public title
effect of Ketamine gargle on post-operative sore throat
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients in class I and II American Society of Anesthesiologists (ASA) classification system,
age range of 18-65 years old
candidates of elective septoplasty surgery with general anesthesia
no pre-operative sore throat
no asthma
no sensitivity to using drugs.
Exclusion criteria:
endotracheal tube intubation more than one time
change of anesthetic technique.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
computer based block design random allocation
Blinding (investigator's opinion)
Double blinded
Blinding description
96 patients were assigned to 3 groups equally by computer based block design random allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Isfahan University of Medical Sciences
Street address
Hezar.Jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2016-05-25, 1395/03/05
Ethics committee reference number
ir.mui.rec.1395.3.502
2
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar-Jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2016-05-25, 1395/03/05
Ethics committee reference number
ir.mui.rec.1395.3.502
Health conditions studied
1
Description of health condition studied
Intubation side effect
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
post operative sore throat
Timepoint
time 1 was immediately after entrance to recovery room , time 2 was 2 hours post operation , time 3 was 4 hours post operation , time 4 was 8 hours post operation and time 5 was 24 hours after operation.
Method of measurement
. Score 0 defined as no sore throat. Score 1 defined as mild sore throat which means sore throat complain only after patients were asked. Score 2 defined as moderate sore throat which means patients complained about sore throat at recovery room before they were asked. Score 3 defined as severe sore throat which means vocal changes or sore throat with hoarseness.
Secondary outcomes
1
Description
complications like headache, nausea, vomiting, dizziness, cough and laryngospasm
Timepoint
time 1 was immediately after entrance to recovery room , time 2 was 2 hours post operation , time 3 was 4 hours post operation , time 4 was 8 hours post operation and time 5 was 24 hours after operation.
Method of measurement
asking patients and observation
Intervention groups
1
Description
Intervention group: Group K received 50 mg Ketamine solved in 29 ml saline
Category
Treatment - Drugs
2
Description
Intervention group: , group G received 100 mg Ketamine solved in 28 ml saline
Category
Treatment - Drugs
3
Description
Control group: group C received 30 ml saline
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
dr.Azim Honarmand
Street address
Ayatol'a Kashani st,felezi bridge, isfahan town
City
ISFAHAN
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3233 0091
Fax
Email
Kashani@domain.com
Web page address
htpp://kashani.mui.ac.ir
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
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2135
Fax
+98 31 3222 2135
Email
honarmand@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi
Position
professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2135
Fax
+98 31 3222 2135
Email
safavi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi
Position
professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2135
Fax
+98 31 3222 2135
Email
safavi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 3222 2135
Fax
+98 31 3222 2135
Email
safavi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
collected for the primary outcome measure only
When the data will become available and for how long
date relative to the time when summary data are published
To whom data/document is available
no limitation
Under which criteria data/document could be used
no limitation
From where data/document is obtainable
contact to:
safavi@med.mui.ac.ir
What processes are involved for a request to access data/document