Abstract
Background and purpose: Fentanyl is commonly used for spinal analgesia during labor but it is associated with a high incidence of pruritus. This randomized, double-blind, placebo-controlled study was performed to evaluate the effect of prophylactic Granisetron on the incidence and severity of pruritus among parturients receiving intrathecal fentanyl in cesarean section surgery.
Materials and methods: 136 ASA I or II women undergoing elective caesarean section received spinal anesthesia with 0.5% hyperbaric bupivacaine 10 mg, fentanyl 25 µg. After delivery of the baby and clamping of the umbilical cord, they were randomized to receive Granisetron 1mg i.v. (group G) or saline 0.9 % (group S).Inclusion criteria were not a history of gastrointestinal disease؛ allergies to medications؛ pre-eclampsia and eclampsia was taken into account. Exclusion criteria was people who have used anti-nausea drug in the last 24 hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016043027677N1
Registration date:2016-06-20, 1395/03/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-20, 1395/03/31
Registrant information
Name
Shahryar Sane
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3223 4897
Email address
sane.sh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of intravenous Granisetron and placebo on pruritus after intrathecal opioid in cesarean section with spinal anesthesia
Public title
Effect of Granisetron on pruritus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria were not a history of gastrointestinal disease؛ allergies to medications؛ pre-eclampsia؛ eclampsia was taken into account.Exclusion criteria was people who have used anti-nausea drug in the last 24 hours.
Age
From 76 years old to 96 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
2cc syringe was used for both groups. Syringe containing the drug and placebo groups A and B are already prepared by someone else, and is tagged that 68 syringe containing drug and 68 syringes containing placebo and after insertion into the box and randomized syringe with any label bring out of the box and was injected to the patients which was achieved without researcher and after completing the questionnaire was informed to the researcher.
Secondary Ids
1
Registry name
none
Secondary trial Id
none
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Urmia University of Medical Sciences
Street address
Jahad Avenue
City
Urrmia
Postal code
5714783734
Approval date
2015-09-09, 1394/06/18
Ethics committee reference number
ir.umsu.rec.1394.190
2
Ethics committee
Name of ethics committee
Urrmia Medical University
Street address
Jahad Avenue
City
Urrmia
Postal code
5714783734
Approval date
2015-09-09, 1394/06/18
Ethics committee reference number
Ir.umsu.rec.1394.190
Health conditions studied
1
Description of health condition studied
opioid induced pruritus
ICD-10 code
L29.9
ICD-10 code description
Itch NOS
Primary outcomes
1
Description
Pruritus
Timepoint
During the surgery and ricovery
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
During surgery and recovery room
Method of measurement
Has- does not have
Intervention groups
1
Description
Immediately after clamping the umbilical cord for study group granisetron ( pharmaceutical company Caspian ) 1 mg by intravenous injected
Category
Treatment - Drugs
2
Description
immediately after clamping the umbilical cord in the same volume of saline in the control group were injected intravenously
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Hospital
Full name of responsible person
Shahryar Sane,Assistant Professor, Anesthesiologist
Street address
Kashani Avenue
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
piivate
Full name of responsible person
Shahryar Sane
Street address
Ershad avenue, Imam Khomeini Hospital, Dipartment of Anesthesia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?