Clinical trial of Comparison of low-dose Midazolam and Propofol on nausea and vomiting induced during operation, in pregnant women undergoing cesarean section with spinal anesthesia
After getting permission from ethics and research Committee of Jahrom university of Medical Sciences, this double blind clinical trial was performed on 42 patients having the inclusion criteria (Pregnant women aged 15 to 60 years old, Class 1 and 2 ASA, Cesarean section candidate, and No physical or mental illness). Patients were divided into two groups A and B randomly by Random Allocation software. They did not receive any special medicine before entering operation room.
Before starting surgery, patients received 7 ml/kg Ringer serum and then while patients received 65 mg Lidocain 5% for spinal anesthesia, group A were under treatment with 1.5mg Midazolam and group B with 2cc (20mg) Propofol.
At the end of surgery patients were transferred to the recovery room. They were kept in recovery room for at least 1 hour. Nausea and vomiting of patients were measured based on their feelings in 1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia by a self-instructive questionnaire.
The patients and the investigator did not have any information about the drugs used.
The aim of this study is to find the best medication to decrease nausea and vomiting after elective cesarean section.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031717039N1
Registration date:2014-07-30, 1393/05/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-30, 1393/05/08
Registrant information
Name
Marjan Jaladat
Name of organization / entity
Medical University of Jahrom
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 6576
Email address
dr.jaladat@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Jahrom university of Medical Science
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Comparison of low-dose Midazolam and Propofol on nausea and vomiting induced during operation, in pregnant women undergoing cesarean section with spinal anesthesia
Public title
Comparison of Midazolam and Propofol on nausea and vomiting induced during cesarean section with spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Written formal consent for operation, Pregnant women aged 15 to 60 years old, Class 1 and 2 ASA, Cesarean section candidate, No physical or mental illness, No consumption of Sedative, Antidepressant, Sleeping or Psychotropic medicine.
Exclusion Criteria: Weight more than 100 kg, Age more than 60 or less than 15, Drug or alcoholic abusers, Treatment by Anti depressant, sleeping and psychotropic pills, Inadequate cooperation with investigator to assess nausea and vomiting after operation, Hospitalization in ICU after operation, Any background of Propofol or Midazolam sensitivity, Need for additional treatment, Becoming ill after surgery, Increased anesthesia level, Respiratory distress, Patients of class 3 and 4 of ASA, Hemodynamic disorders
Age
From 15 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
7414846199, Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran
City
Jahrom
Postal code
7414846199
Approval date
2013-05-29, 1392/03/08
Ethics committee reference number
jums.rec.1392.005
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
k91.9
ICD-10 code description
Postprocedural disorder of digestive system, unspecified
Primary outcomes
1
Description
Nausea and Vomiting
Timepoint
1 ,3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia
Method of measurement
Have or not have with the Questionnaire made by Investigator
Secondary outcomes
1
Description
Blood pressure
Timepoint
1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia
Method of measurement
Sphygmomanometer
2
Description
Pulse
Timepoint
1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia
Method of measurement
Pulse oximetry
3
Description
Respiratory Rate
Timepoint
1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia
Method of measurement
Counting breaths by investigator
4
Description
O2 Saturation of arterial blood
Timepoint
During surgery and recovery
Method of measurement
Pulse oximetry
5
Description
Apgar
Timepoint
1 and 5 minutes after the birth
Method of measurement
Assessment by investigator by Apgar criteria
Intervention groups
1
Description
Patients were divided into two groups A and B randomly by Random Allocation software. They did not receive any special medicine before entering operation room.
Before starting surgery, patients received 7 ml/kg Ringer serum and then While patients got 65 mg Lidocain 5% for spinal anesthesia, group A were injected 1.5mg Midazolam.
At the end of surgery patients were transferred to the recovery room. They were kept in recovery room for at least 1 hour. Nausea and vomiting of patients were measured based on their feelings in 1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia by a self-instructive questionnaire.
The patients and the investigator did not have any information about the drugs used.
Category
Prevention
2
Description
Patients were divided into two groups A and B randomly by Random Allocation software. They did not receive any special medicine before entering operation room.
Before starting surgery, patients received 7 ml/kg Ringer serum and then While patients got 65 mg Lidocain 5% for spinal anesthesia, group B were injected 2cc (20mg) Propofol.
At the end of surgery patients were transferred to the recovery room. They were kept in recovery room for at least 1 hour. Nausea and vomiting of patients were measured based on their feelings in 1, 3, 5, 10, 15, 30 and 60 minutes after spinal anesthesia by a self-instructive questionnaire.
The patients and the investigator did not have any information about the drugs used.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital affiliated with the University of Medical Sciences
Full name of responsible person
Marjan Jaladat
Street address
7414846199, Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Jahrom University of Medical Sciences
Full name of responsible person
Kavoos Solh joo
Street address
7414846199, Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran
City
Jahrom
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, Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Marjan Jaladat
Position
Medical Student
Other areas of specialty/work
Street address
7414846199, Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran
City
Jahrom
Postal code
7414846199
Phone
+98 79133404059
Fax
Email
Marjan.Jaladat@gmial.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Hassan Zabetian
Position
Anesthesiologist
Other areas of specialty/work
Street address
7414846199, Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran
City
Jahrom
Postal code
Phone
+98 79 1334 0405
Fax
Email
Dr.Jaladat@jums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Marjan Jaladat
Position
Medical Student
Other areas of specialty/work
Street address
7414846199, Motahari Street, Jahrom University of Medical Sciences, Jahrom, Fars, Iran
City
Jahrom
Postal code
7414846199
Phone
+98 79133404059
Fax
Email
Marjan.Jaladat@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)