Protocol summary

Summary
The aim of this study is the evaluation of the efficiency of ginger Vs.metoclopramid in prevention of postoperative nausea and vomiting and intraoprative nausea and vomiting in patients undergoing cesarean selection. This study is clinical trial. Inclusion criteria: 18-40 years old patients undergoing cesarean with spinal. Exclusion criteria: Any history of an allergy of metoclopramid and ginger; any history of any gastrointestinal surgery on stomach, upper GI and gall bladder; any history of bleeding disorder (haemophilia, ITP); any contraindication to intrathecal or epidural anaesthesia (Arnold- chiari); high risk patient for anaesthesia (ASA III, IV); any history of using anaesthesia drugs and metoclopramid doses at 24 hours befor the surgery. 180 pregnant woman who candidate for elective cesarean with spinal anaesthesia, woman randomly assigned into 2 groups: ginger and metoclopramid. Woman in ginger group received 1 gr capsule and metoclopramid group received 10 mg ampule of metoclopramid both 30 minutes before induction of anaesthesia. The number of nausea and vomiting is measured at 1, 2, 6, 24 hours post operatin and registered.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201611028611N3
Registration date: 2017-01-31, 1395/11/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-31, 1395/11/12
Registrant information
Name
Hamideh Pakniat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 282242452
Email address
hpakniat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Science
Expected recruitment start date
2016-10-23, 1395/08/02
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ginger versus metoclopramid in prevention of nausea and vomiting in patients undergoing cesarean section with spinal anaesthesia
Public title
The effect of ginger versus metoclopramid in prevention of nausea and vomiting in patients undergoing cesarean section with spinal anaesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18-40 years old patients undergoing cesarean with spinal anaesthesia. Exclusion criteria: Any history of an allergy to metoclopramid and ginger; any history of gastrointestinal surgery on stomach, upper GI and gall bladder; any history of bleeding disorder (haemophilia, ITP); any contraindication to intrathecal or epidural anaesthesia (Arnold- chiari); high risk patient for anaesthesia (ASA III, IV); any history of using antiemetic drugs and metoclopramid doses at 24 hours befor the surgery.
Age
From 18 years old to 40 years old
Gender
Female
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)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Bahonar Blvd, Qazvin, Iran
City
Qazvin
Postal code
3419759811
Approval date
2015-11-08, 1394/08/17
Ethics committee reference number
IR.QUMS.REC.1394.205 , 28/20/11114

Health conditions studied

1

Description of health condition studied
pregnancy
ICD-10 code
o08
ICD-10 code description
normal pregnancy

Primary outcomes

1

Description
Times of nausea
Timepoint
Evaluate and record during the operation and 1, 2, 6 and 24 hours after surgery.
Method of measurement
Self-report tool

2

Description
Severity of Vomiting
Timepoint
Evaluate and record during the operation and 1, 2, 6 and 24 hours after surgery.
Method of measurement
Self-report tool

Secondary outcomes

empty

Intervention groups

1

Description
Intervention/Control 1: First group received 1 gr ginger capsule (product of Dineh pharmaceutical company.Qazvin)30 minutes before induction of anaesthesia
Category
Treatment - Drugs

2

Description
Intervention/Control 2 : Second group received 10 mg ampule of metoclopramid (product of Caspian pharmaceutical company.Gilan)30 minutes before induction of anaesthesia.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Hamideh Pakniat
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research of Qazvin University of Medical Sciences
Full name of responsible person
Dr. Naser taghi poor farivar
Street address
Iran, Qazvin, Bahonar Blvd
City
Qazvin
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 Qazvin 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
Kowsar Hospital
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology Qazvin University of Medical Sciences
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
3415613176
Phone
+98 28 3333 6001
Fax
Email
pakniat110@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
3415613176
Phone
+98 32236374
Fax
Email
pakniat110@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kowsar Hospital
Full name of responsible person
Dr Hamideh Pakniat
Position
Asistant Professor, Department of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Kowsar Hospital, Taleghani St, Qazvin, Iran
City
Qazvin
Postal code
3415613176
Phone
+98 28 3223 6374
Fax
Email
pakniat110@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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