Comparison the effects of preoperative Ketamine gargle with Benzidamine on the rate of sore throat after general anesthesia in patients under Hysterectomy during in the year 2011 - 2012 in Tehran Rasul Akram Hospital.
Objectives : Comparison the effect of preoperative Ketamine gargle with Benzidamine on the rate of sore throat after general anesthesia
Design : Randomized double blind , control with placebo
Setting and conduct : Dividing patients into three groups of 20 people and prescribing random Ketamine or Benzydamine or placebo for gargle before induction of anesthesia and intubation
Participants including major eligibility criteria;
women 15-60 year; ASA = 1- 2 ; patients candidate for elective Hysterectomy
Participants excluding major eligibility criteria; The lack of consent of the patients; drug and alcohol abuse; diabetes; HTN ; a history of sore throat and colds causing by infectious during the 2 weeks before surgery; difficult intubation (more than once trying for intubation)
Intervention : Prescribing for gargle Ketamine (20 mg in 19 ml normal saline) or Benzydamine (1.5 mg in 19 ml normal saline) or 20 ml of normal saline (placebo), 5 minutes before intubation in three random groups
Main outcome measures variables : Check the amount of sore throat in patients in 0 , 2 and 24 hours , after extubation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102311225N1
Registration date:2012-12-03, 1391/09/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-03, 1391/09/13
Registrant information
Name
Naghmeh Nikzad
Name of organization / entity
Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 4436 4895
Email address
n-nikzad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of preoperative Ketamine gargle with Benzidamine on the rate of sore throat after general anesthesia in patients under Hysterectomy during in the year 2011 - 2012 in Tehran Rasul Akram Hospital.
Public title
Comparison the effect of preoperative Ketamine gargle with Benzidamine on the rate of sore throat after general anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria; women 15 to 60 years old ; (ASA = 2, 1) ; candidate for elective Hysterectomy; written consent to the inclusion.
Exclusion criteria; no satisfaction ; age under 15 years and above 60 years ; substance abuse Drugs and alcohol ; Diabetes ; HTN ; previous hypersensitivity to anesthetic drugs; liver and kidney failure; Infectious causes of sore throats and colds during the 2 weeks before surgery; difficult intubation (more than once trying for intubation)
Age
From 15 years old to 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethics committee Tehran university of medical science
Street address
Faculty of medicine , Poorsina avenue , Keshavarz street , Tehran
City
Tehran
Postal code
Approval date
2011-06-27, 1390/04/06
Ethics committee reference number
90/ص/210/3716
Health conditions studied
1
Description of health condition studied
postoperative sorethroat
ICD-10 code
R07
ICD-10 code description
Pain in throat and chest
Primary outcomes
1
Description
postoperative sorethroat
Timepoint
0,2,24 hour postoperation
Method of measurement
VAS
Secondary outcomes
1
Description
heart rate & blood pressure
Timepoint
before & after gargling and intubation
Method of measurement
monitoring of HR & BP
Intervention groups
1
Description
Group Benzydamine ; gargle of 1.5 mg Benzydamine in 20 cc Normal saline five minutes before intubation.
Category
Treatment - Drugs
2
Description
Group Ketamine ; gargle of 20 mg Ketamine in 20 cc Normal saline five minutes before intubation.
Category
Treatment - Drugs
3
Description
Group control ; gargle of 2o cc Normal saline five minutes before intubation.