Comparison the effect of intravenous ondansetron and sub-hypnotic propofol dose on pruritus after intrathecal opioid in patient with elective cesarean surgery
The aim of this study was to compare the effect of intravenous ondansetron and sub-hypnotic dose of propofol in control and treatment of intrathecal fentanyl induced pruritus in cesarean surgery. Inclusion criteria: 20 to 40 years old; patient with class I and II America society of Anesthesiologists; cesarean surgery with spinal anesthesia. Exclusion criteria: any complaints of pruritus before surgery; start pruritus before closing cord; allergy to medications; preeclampsia; eclampsia; people who had used anti-nausea drug in the past 24 hours. 90 Patients undergoing spinal anesthesia with 25 μg fentanyl and 10 mg bupivacaine 0.5% will be enrolled to this randomized, prospective study. The women based on random numbers table will be assigned to two groups (45) who received 4 mg ondansetron or 10 mg propofol and then 10 μg/kg/min infused intraoperative after closing the cord. The incidence and intensity of pruritus (Primary outcome), nausea and vomiting (secondary outcome) will be evaluated intraoperative and in the recovery. If the pruritus is on-going, the exact treatment with naloxone will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041527677N7
Registration date:2017-07-21, 1396/04/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-21, 1396/04/30
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
Vice Chancellor for research of Urmia University of Medical Sciences
Expected recruitment start date
2016-07-27, 1395/05/06
Expected recruitment end date
2017-03-26, 1396/01/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of intravenous ondansetron and sub-hypnotic propofol dose on pruritus after intrathecal opioid in patient with elective cesarean surgery
Public title
Clinical trial the effect of intravenous ondansetron and sub-hypnotic propofol dose on pruritus after intrathecal opioid in patient with elective cesarean surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:20 to 40 years old; patient with class I and II America society of Anesthesiologists; cesarean surgery with spinal anesthesia
Exclusion criteria: any complaints of pruritus before surgery; start pruritus before closing cord; allergy to medications; preeclampsia; eclampsia; people who had used anti-nausea drug in the past 24 hours.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will be divided into two groups by random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Urmia University of Medical Sciences
Street address
Emergent Street, Ershad Avenue
City
Urmia
Postal code
5714783734
Approval date
2016-07-27, 1395/05/06
Ethics committee reference number
171.IR.UMSU.REC.13950299
Health conditions studied
1
Description of health condition studied
opioid induced pruritus
ICD-10 code
L29.9
ICD-10 code description
Pruritus, unspecified
2
Description of health condition studied
nausea and vomiting
ICD-10 code
O21.9
ICD-10 code description
Vomiting of pregnancy, unspecified
Primary outcomes
1
Description
Pruritus
Timepoint
During the surgery and recovery
Method of measurement
visual analog scale
Secondary outcomes
1
Description
Nausea and vomiting
Timepoint
During the surgery and recovery
Method of measurement
Has- does not have
Intervention groups
1
Description
Intervention group 1: Immediately after clamping the umbilical cord for first study group ondansetron 4 mg (Exir Company) by intravenous will be injected.
Category
Treatment - Drugs
2
Description
Intervention group 2: Immediately after clamping the umbilical cord for second study group 10 mg propofol (Fresnius Kabi Company) and then 10 μg/kg/min will be infused intraoperative.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar operating room, Motahhari Hospital
Full name of responsible person
Shahryar Sane
Street address
Kashani Avenue
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Urmia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Street address
Emergent Street, Resalat avenue, Urmia
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Urmia University of Medical Sciences
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
Urmia University of Medical Sciences
Full name of responsible person
Shahryar Sane
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Motahhari Hospital, Kashani Avenue