This study is conducted to compare the effect of ketamine with remifentanil on the Blood sugar of patients undergoing laparoscopic cholecystectomy. In the present double blind clinical trial a total of 120 patients who refer for an elective cholecystectomy operation will be included in this study based on our inclusion and exclusion criteria.Randomly we will classify our patients to three groups. Group 1 will receive ketamine infusion with the dose of 10 μg/kg/min. We will infuse 1μg/kg/min remifentanil for patients in group 2 and group 3 will not receive neither drugs and will be our control group. General anesthesia will be induced for all groups with the same drug and will be continued with isoflurane. the level of blood sugar for each patients will be determined by glucometer before, after and every hour during operation.
General information
Acronym
None
IRCT registration information
IRCT registration number:IRCT201701237745N5
Registration date:2017-05-16, 1396/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-16, 1396/02/26
Registrant information
Name
Afshin Mansourian
Name of organization / entity
YUMS
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0620
Email address
afshin.mansourian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Yasuj University Of Medical Sciences
Expected recruitment start date
2015-01-24, 1393/11/04
Expected recruitment end date
2016-04-24, 1395/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of ketamine and remifentanil on the level of Blood sugar during Laparoscopic Cholecystectomy
Public title
The effect of ketamine and remifentanil on stress and level of blood sugar intra-operation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 20-70-year-old patients who undergo an elective cholecystectomy which takes at last 2 hours, patients must be categorized as class 1 according to American Society of Anesthesiologists Physical status Classification.
Exclusion criteria: Diabetic patients, patients with cardiovascular diseases, Beta blocker consumption, hypo and hyperglycemic agents consumption, consuming dextrose solutions or sympathetic blocker agents during the operation, intubation lasting more than 20 seconds
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
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
Not used
Assignment
Parallel
Other design features
In the current study we will use permuted block randomization with the block size of 8
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of medical sciences
Street address
Shahid Motehari biv.,vicechancellory of research and technology ,kohgiluyeh and boyerahmad
City
Yasuj
Postal code
Approval date
2017-02-01, 1395/11/13
Ethics committee reference number
IR.YUMS.REC.1395.199
Health conditions studied
1
Description of health condition studied
Cholelithiasis
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis
2
Description of health condition studied
blood glucose
ICD-10 code
-R73.9
ICD-10 code description
-Hyperglycaemia, unspecified
3
Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Blood Glucose
Timepoint
Immediately before and after induction of anesthesia and every hour after induction
Method of measurement
By using glucometer, milligrams per deciliter
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Group 1 will receive 10 μg/kg/min ketamine.
Category
Prevention
2
Description
Group 2 will receive 1 μg/kg/min remifentanil.
Category
Treatment - Drugs
3
Description
Control group will not receive neither ketamine nor remifentanil.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Afshin Mansourian
Street address
Shahid Motehari Blv.
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasuj University of Medical Science
Full name of responsible person
Hossein Mari-oryad
Street address
Yasuj
City
Yasuj
Grant name
Grant code / Reference number
None
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj University of Medical Science
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
YUMS
Full name of responsible person
Afshin Mansourian
Position
Anesthesiologist/Assisstant professor
Other areas of specialty/work
Street address
Shahid Beheshti Hospital
City
Yasuj
Postal code
7591984117
Phone
+98 74 3322 0620
Fax
None
Email
afshin.mansourian@yahoo.com
Web page address
None
Person responsible for scientific inquiries
Contact
Name of organization / entity
YUMS
Full name of responsible person
Afshin Mansourian
Position
Assisstant professor/Anesthesiologist
Other areas of specialty/work
Street address
YUMS
City
Yasuj
Postal code
7591984117
Phone
+98 74 3322 0620
Fax
+98 74 3323 5153
Email
Afshin.mansourian@yahoo.com
Web page address
WWW.yamc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
YUMS
Full name of responsible person
Afshin Mansourian
Position
assisstent professor
Other areas of specialty/work
Street address
Shahid Beheshti Hospital
City
Yasuj
Postal code
76658909
Phone
+98 74 3322 0620
Fax
+98 74 3322 0620
Email
afshin.mansourian@yahoo.com
Web page address
None
Sharing plan
Deidentified Individual Participant Data Set (IPD)