Comparison of the efficacy and complications of different doses of granisetron in prophylaxis of intrathecal sufentanil induced-pruritus in patients undergoing lower limb surgery in Emam Khomeini hospital during 1391-92
In this double blind randomized clinical trial, the efficacy of tree different doses of granisetron in prophylaxis of intrathecal sufentanil induced-pruritus will study on male and female patients between 18 to 65 years old of American Society of Anesthesiologists class I,II that have consent to do spinal block for them and dont have disorders of cardiac,hepatic,renal and spinal deformity undergoing lower limb orthopedic surgery. In this study 180 patients divide in 4 groups , 30 minutes before spinal block and administration of intrathecal opioid, in first group 10 mcg/kg,second group 40 mcg/kg ,third group 60 mcg/kg granisetron and in fourth group normal saline as a placebo will infuse during 1 minutes. during surgery and after that until 24 hours,the patients will evaluate of pruritus and other probable complications caused by granisetron and finally all of these four groups will be compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072414149N1
Registration date:2013-09-07, 1392/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-07, 1392/06/16
Registrant information
Name
Samira Kazem
Name of organization / entity
Tehran University of Medical Science, School of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 21 4403 3836
Email address
s_kazem@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-09, 1391/03/20
Expected recruitment end date
2012-12-11, 1391/09/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and complications of different doses of granisetron in prophylaxis of intrathecal sufentanil induced-pruritus in patients undergoing lower limb surgery in Emam Khomeini hospital during 1391-92
Public title
The effect of granisetron in prophylaxis of intrathecal opioid induced-pruritus
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria : ASA class I-II
exclusion criteria :male less than 18 years old; male more than 65 years old; fmale less than 18 years old; fmale more than 65 years old; ASA Class III; ASA Class IV; patient refuse from performing spinal block; patients with spinal deformities; patients with mental disorders; patients with local skin infections; history of anaphylaxis to local anesthetics,sufentanil and granisetron; patients with coagulation disorders; patients with severe hepatic disease; patients with renal function disorder; patients with body wheight more than 100 kilograms; patients dependent to opioid; patients with severe chronic obstructive pulmonary disease (FEV1 less than 600cc); height less than 150 cm or more than 180 cm; known cardiac disease; patients with long QTsyndrome
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:
180
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
Tehran University of Medical Science, Research council of Medical school
Street address
medical School of Medicine, north side of Tehran University, Poursina street
City
Tehran
Postal code
1417613151
Approval date
2012-07-01, 1391/04/11
Ethics committee reference number
399
Health conditions studied
1
Description of health condition studied
intrathecal opioid induced-pruritus
ICD-10 code
L29.8
ICD-10 code description
other pruritus
Primary outcomes
1
Description
pruritus
Timepoint
30 minutes-0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
Visual Analogue Scales and Verbal Rating Scales for assessment of the severity of pruritus
Secondary outcomes
1
Description
pain
Timepoint
30 minutes- 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
Visual Analogue Scales for assessment of pain
2
Description
nausea
Timepoint
30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
observation
3
Description
vomiting
Timepoint
30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
observation
4
Description
shivering
Timepoint
30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
observation
5
Description
blood pressure
Timepoint
30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
mmHg
6
Description
haert rate
Timepoint
30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
beats/min
7
Description
respiratory rate
Timepoint
30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours -8 to 24 hours after intervention
Method of measurement
beats/min
8
Description
arterial oxygen saturation
Timepoint
30 minutes - 0.5 to 2 hours - 2 to 4 hours- 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
percent
9
Description
drowsiness
Timepoint
30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
Ramsey sedation score
10
Description
headache
Timepoint
30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
observation
11
Description
allergic reaction
Timepoint
30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
observation
12
Description
arrythmia
Timepoint
30 minutes - 0.5 to 2 hours - 2 to 4 hours - 4 to 8 hours - 8 to 24 hours after intervention
Method of measurement
observation
Intervention groups
1
Description
control group:normal saline as placebo 4.5 mL intravenously
Category
Placebo
2
Description
group 1 : granisetron 10 mcg/kg + normal saline up to total volume of 4.5 mL intravenously
Category
Prevention
3
Description
group 2 : granisetron 40 mcg/kg + normal saline up to total volume of 4.5 mL intravenously
Category
Prevention
4
Description
group 3 : granisetron 60 mcg/kg + normal saline up to total volume of 4.5 mL intravenously
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic Operating Room, Emam Khomeini Hospital
Full name of responsible person
Dr.A.P.Zanjani, Assistant Professor, Anesthesiologist
Street address
Emam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Dr.SH.Akhondzadeh, Research Assistant of Medical School
Street address
School of Medicine, North side of Tehran University ,Poursina street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Science, School of Medicine
Full name of responsible person
Samira - Kazem
Position
Resident Anesthesia
Other areas of specialty/work
Street address
School of Medicine, North side of Tehran University,Poursina street
City
Tehran
Postal code
1417613151
Phone
+98 21 6640 0917
Fax
+98 21 6640 4377
Email
s_kazem@razi.tums.ac.ir
Web page address
http://medicine.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science, School of Medicine
Full name of responsible person
Dr.J.Makarem
Position
Assistant Professor, Anesthesiologist
Other areas of specialty/work
Street address
School of Medicine, North side of Tehran University, Poursina street
City
Tehran
Postal code
1417613151
Phone
+98 21 6640 0917
Fax
+98 66404377
Email
s.akhond@neda.netj_makarem@razi.tums.ac.ir
Web page address
http://medicine.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
School of Medicine, Tehran University of Medical Science
Full name of responsible person
Dr.J.Makarem
Position
Assisstant Professor of Anesthesiology
Other areas of specialty/work
Street address
School of Medicine, North side of Tehran University, Poursina street
City
Tehran
Postal code
1417613151
Phone
+98 21 6640 0917
Fax
+98 21 6640 4377
Email
j_makarem@razi.tums.ac.ir
Web page address
http://medicine.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)