Evaluation of the effect of Intravenous dexamethasone vs. ketamine gargle vs. intravenous dexamethasone combined with ketamine gargle on post operative sore throat and hoarseness
This study was performed to evaluate the efficacy of intravenous dexamethasone plus ketamine gargle for reducing the incidence and severity of post operative sore throat and hoarseness.
The main Inclusion criteria were : Patients between 18 and 65 years of age,with American society of anesthesiologists physical status (ASA) I–II, who were scheduled for elective surgery under general anesthesia in Kashni hospital of Isfahan city that requiring one-lung ventilation and the main exclusion criteria was; those who required more than one attempt for tracheal intubation.This double blind clinical trial was performed on140 patients. Patients were randomly allocated into four groups of 35 subjects each:
before induction of anesthesia,Group K, gargled 40mg ketamine in 30 ml saline; Group D, were infused 0.2 mg/kg intravenous (IV) dexamethasone; Group KD, gargled 40mg ketamine in 30ml saline plus 0.2mg/kg intravenous dexamethasone; Group P (placebo) that received saline (gargle and IV). Post operative sore throat and hoarseness were graded at 0, 2, 4,8,16 and 24 h after operation on a four-point scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305165362N5
Registration date:2013-06-12, 1392/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-06-12, 1392/03/22
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
2011-10-01, 1390/07/09
Expected recruitment end date
2012-10-01, 1391/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Intravenous dexamethasone vs. ketamine gargle vs. intravenous dexamethasone combined with ketamine gargle on post operative sore throat and hoarseness
Public title
Evaluation of the effect of Intravenous dexamethasone vs. ketamine gargle vs. intravenous dexamethasone combined with ketamine gargle on post operative sore throat and hoarseness
Purpose
Prevention
Inclusion/Exclusion criteria
Patients without a history of preoperative sore throat and asthma;Patients without recent NSAID medication; mouth opening of >3.5cm;a Cormack score of lower than 4; patients with duration of surgery between 60-300 min ;known allergies to study drugs; known difficulty with tracheal intubation.
Exclusion criteria were: Those who required more than one attempt for tracheal intubation; Patients with the requirement of mechanical lung ventilation after surgery in the intensive care unit.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Anesthesiology and Critical Care Research Center,Isfahan University of Medical Sciences, Isfahan, Ir
Street address
Anesthesiology and Critical Care Research Center,Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
8174675731
Approval date
2011-07-06, 1390/04/15
Ethics committee reference number
390193
Health conditions studied
1
Description of health condition studied
acute sore throat
ICD-10 code
J02.9
ICD-10 code description
Acute pharyngitis, unspecified
2
Description of health condition studied
hoarseness
ICD-10 code
R49.0
ICD-10 code description
Dysphonia
Primary outcomes
1
Description
sore throat
Timepoint
On arrival in the post-anesthesia care unit (0 h), and at 2, 4, 8,16and 24 h thereafter,
Method of measurement
0, no sore throat; 1, mild sore throat (complains of sore throat only on asking); 2, moderate sore throat (complains of sore throat on his/her own); and 3, severe sore throat (change of voice or hoarseness, associated with throat pain).
2
Description
hoarseness
Timepoint
On arrival in the post-anesthesia care unit (0 h), and at 2, 4, 8,16and 24 h thereafter,
Method of measurement
watching-0, No hoarseness; 1, Hoarseness at the time of interview, but noted only by patient; 2, Hoarseness that is readily apparent, but mild; 3, Hoarseness that is readily apparent and severe.
Secondary outcomes
1
Description
Recovery time(min)
Timepoint
times from discontinuation of anesthesia until the time to achieve a modified Aldrete score of 9
Method of measurement
aldrete score
2
Description
the duration of tracheal intubation
Timepoint
the duration of tracheal intubation
Method of measurement
watching
3
Description
Sedation
Timepoint
during interviewed the patients to investigate the POST(post operative sore throat) (0,2,4,8,16,24h after tracheal extubation)
Method of measurement
using the four-point Observer’s Assessment of Alertness/ Sedation (OAA/S) scale (where 0 = awake/alert and 3 = deep sleep)
Intervention groups
1
Description
Group K, who gargled 40mg ketamine in 30 ml normal saline for 30 s and received 2mg/kg intravenous saline, 5 min before induction anesthesia.
Category
Prevention
2
Description
Group D, who gargled 30ml normal saline for 30 s and received 0.2mg/kg intravenous dexamethasone, 5min before induction anesthesia.
Category
Prevention
3
Description
Group KD, who gargled 40 mg ketamine in 30 ml normal saline and received 0.2mg/kg intravenous dexamethasone, 5min before induction anesthesia.
Category
Prevention
4
Description
Group P who received a placebo of normal saline (gargled 30 ml normal saline for 30 s and received 0.2mg/kg intravenous normal saline, 5min before induction of anesthesia).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Dr Azim Honarmand
Street address
Isfahan,Kashani street,Kashani hospital,
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Anesthesiology and Critical Care Research Center,Isfahan University of Medical Sciences, Isfahan, Ir
Full name of responsible person
Dr Azim Honarmand
Street address
Anesthesiology and Critical Care Research Center,Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfarhan
Grant name
ندارد
Grant code / Reference number
no
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesiology and Critical Care Research Center,Isfahan University of Medical Sciences, Isfahan, Ir
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
Isfahan University of Medical Sciences, Isfahan, Iran
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
Isafahan
Postal code
8174675731
Phone
+98 311
Fax
+98 31 1668 4510
Email
Honarmand@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
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 1625 5555
Fax
+98 31 1668 4510
Email
Honarmand@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan, Iran
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
Isafahan
Postal code
8174675731
Phone
+98 311
Fax
+98 31 1668 4510
Email
Safavi@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)