The overall goal: to determine and Comparison effects of intravenous midazolam and ondansetron on nausea and vomiting after spinal anesthesia for cesarean section. Study design: Randomized, single-blind, No placebo-controlled. The study population: consists of patients who were referred for elective cesarean section Fatemieh Hospital operating room in Hamadan City Inclusion criteria: Age 18-40 years and undergoing cesarean section; physical status class I or II in accordance with anesthesia; Term pregnancy (gestational age 36-40 weeks); Singleton pregnancy. Exclusion criteria: High-risk pregnancy; A history of liver, Mental, renal, gastrointestinal disorders and motion sickness; history of hyperemesis gravidarum; The patients who received antiemetics during previous 24 hours; history of drug addiction; history of postoperative nausea and vomiting; Patients with spinal anesthesia ban. The sample size: In this study, 40 patients in each group is examined. Intervention or interventions studied: Patients were randomly divided into two groups A Midazolam 20 µg / kg, Group B ondansetron 4mg divided. Drugs after clamping the umbilical cord is injected intravenously. Primary outcome: Nausea and vomiting will be evaluated using standard 0 to 3 and severity nausea will be evaluated by Visual analogue scale. Secondary outcome: Patients' satisfaction and complications such as Changes in blood pressure and heart rate, arterial oxygen saturation will be reviewed .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021112251N4
Registration date:2017-05-27, 1396/03/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-27, 1396/03/06
Registrant information
Name
Nasim Alipour
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 312 6716
Email address
n.alipour@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Hamadan University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects of intravenous midazolam and ondansetron on nausea and vomiting after spinal anesthesia for cesarean section
Public title
effects of midazolam and ondansetron on nausea and vomiting after spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-40 years and undergoing cesarean section; physical status class I or II in accordance with anesthesia; Term pregnancy (gestational age 36-40 weeks); Singleton pregnancy.
Exclusion criteria: High-risk pregnancy; Preeclampsia; A history of liver, Mental, renal, gastrointestinal disorders and motion sickness; history of hyperemesis gravidarum; The patients who received antiemetics during previous 24 hours; history of drug addiction; history of postoperative nausea and vomiting; Patients with spinal anesthesia ban.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to two groups using Random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan
City
Hamadan
Postal code
6517838695
Approval date
2017-01-14, 1395/10/25
Ethics committee reference number
IR.UMSHA.REC.1395.444
Health conditions studied
1
Description of health condition studied
post spainal nausea and vomiting
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Since spinal anesthesia or intravenous of midazolam or ondansetron
Method of measurement
Nausea vomiting scale
2
Description
Nausea intensity
Timepoint
Since spinal anesthesia or intravenous of midazolam or ondansetron
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Hemodynamic instability
Timepoint
during the surgery and recovery
Method of measurement
vital sign monitoring device
2
Description
heart rate
Timepoint
during the surgery and recovery
Method of measurement
vital sign monitoring device
3
Description
arterial blood oxygen saturation
Timepoint
during the surgery and recovery
Method of measurement
vital sign monitoring device
4
Description
Patients' satisfaction
Timepoint
In recovery
Method of measurement
4 point Likert scale. Including low satisfaction, average, good and excellent.
Intervention groups
1
Description
In First group, we will inject 20µg /kg of Midazolam IV. after clamping the umbilical cord.
Category
Prevention
2
Description
In Second group, we will inject 4mg of ondansetron IV. after clamping the umbilical cord.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Zahra Ghasemlo
Street address
Fatemieh hospital, Pasdaran Ave
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 Hamadan 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
Hospital Fatemieh
Full name of responsible person
Zahra Ghasemlo
Position
Student Anesthesiology
Other areas of specialty/work
Street address
Fatemieh hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3827 7012
Fax
Email
zahra_ghasemlou@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Para Medicine
Full name of responsible person
Nasim Alipour
Position
Master of Critical Care Nurses, Clinical Instructor
Other areas of specialty/work
Street address
School of Para medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
009818
Phone
+98 918 312 6716
Fax
Email
n.alipour@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Para medicineP
Full name of responsible person
Nasim Alipour
Position
Master of Critical Care Nurses, Clinical Instructor
Other areas of specialty/work
Street address
School of Para medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
009818
Phone
+98 918 312 6716
Fax
Email
n.alipour@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)