Protocol summary
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Study aim
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determining the effect of two different dose of ketamine gargling on the incidence and severity of postoperative sore throat.
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Design
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double blind, randomized controlled trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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1- 50 mg Ketamine solved in 29 ml saline.
2- 100 mg Ketamine solved in 28 ml saline
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Main outcome variables
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Post- operative sore throat
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20101211005362N22
Registration date:
2018-09-17, 1397/06/26
Registration timing:
prospective
Last update:
2019-02-13, 1397/11/24
Update count:
1
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Registration date
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2018-09-17, 1397/06/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-20, 1397/06/29
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Expected recruitment end date
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2018-11-20, 1397/08/29
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Actual recruitment start date
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2018-09-20, 1397/06/29
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Actual recruitment end date
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2018-11-20, 1397/08/29
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Trial completion date
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2018-11-20, 1397/08/29
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Scientific title
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Prophylactic effects of Ketamine gargle on post-operative sore throat: A double blinded randomized controlled trial
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Public title
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effect of Ketamine gargle on post-operative sore throat
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
96
Actual sample size reached:
96
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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computer based block design random allocation
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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96 patients were assigned to 3 groups equally by computer based block design random allocation.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-05-25, 1395/03/05
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Ethics committee reference number
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ir.mui.rec.1395.3.502
2
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Ethics committee
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Approval date
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2016-05-25, 1395/03/05
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Ethics committee reference number
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ir.mui.rec.1395.3.502
Health conditions studied
1
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Description of health condition studied
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Intubation side effect
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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post operative sore throat
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Timepoint
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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.
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Method of measurement
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. 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
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Description
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complications like headache, nausea, vomiting, dizziness, cough and laryngospasm
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Timepoint
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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.
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Method of measurement
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asking patients and observation
Intervention groups
1
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Description
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Intervention group: Group K received 50 mg Ketamine solved in 29 ml saline
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Category
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Treatment - Drugs
2
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Description
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Intervention group: , group G received 100 mg Ketamine solved in 28 ml saline
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Category
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Treatment - Drugs
3
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Description
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Control group: group C received 30 ml saline
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Esfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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collected for the primary outcome measure only
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When the data will become available and for how long
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date relative to the time when summary data are published
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To whom data/document is available
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no limitation
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Under which criteria data/document could be used
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no limitation
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From where data/document is obtainable
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contact to:
safavi@med.mui.ac.ir
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What processes are involved for a request to access data/document
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no limitation
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Comments
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no comments