Protocol summary

Study aim
Comparative Evaluation of intravenous Propofol and Midazolam on sedation and nausea & vomiting during spinal anesthesia in cesarean section
Design
102 Pregnant women aged 18-46 years undergoing cesarean section undergoing spinal anesthesia will be in double blind randomized clinical trial. in one of the two intravenous administration of 0.2 mg/kg Propofol and 0.02 mg/kg Midazolam.
Settings and conduct
102 Pregnant women aged 18-46 years undergoing cesarean section undergoing spinal anesthesia who will be referred to the Besat Hospital of Hamadan during the study period, will be randomly assigned to randomized allocation blocks by random sampling. In order to prevent the medication being detectable for patients and investigators, they are prepared and injected into syringes of the same size and shape.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 18-45 aged pregnant women for C/S; ASA CLASS 1, 2; Satisfaction to participate in the project; Pregnant women who underwent cesarean section under spinal anesthesia. Exclusion Criteria: sensitivity to medications used; Patients who have failed spinal anesthesia and undergo general anesthesia; Lung disease, heart disease, asthma, fever, hypertension, preeclampsia and eclampsia, cardiac arrhythmia; Emergency Cesarean; Eclampsia and Preeclampsia; Multiple pregnancy; Spinal anesthesia contraindications (high ICP, hypovolemia, anemia, coagulation disorders, etc.); History of allergy to eggs, soy, midazolam and propofol; Use of antiemetic drugs
Intervention groups
Intervention group 1: The amount of 0.2 mg/kg Propofol intravenously after spinal anesthesia by an anesthesiologist injected intravenously. 2 intervention groups: the amount of 0.02 mg/kg Midazolam after spinal anesthesia by an anesthesiologist injected intravenously.
Main outcome variables
Sedation score, time to start sedation and duration of sedation, nausea and vomiting

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120915010841N21
Registration date: 2019-11-14, 1398/08/23
Registration timing: registered_while_recruiting

Last update: 2019-11-14, 1398/08/23
Update count: 0
Registration date
2019-11-14, 1398/08/23
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of intravenous Propofol and Midazolam on sedation and nausea & vomiting during spinal anesthesia in cesarean section
Public title
Evaluation of intravenous Propofol and Midazolam on sedation during spinal anesthesia in cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-45 aged pregnant women for C/S ASA CLASS 1, 2 Satisfaction to participate in the project Pregnant women who underwent cesarean section under spinal anesthesia
Exclusion criteria:
sensitivity to medications used Patients who have failed spinal anesthesia and undergo general anesthesia Lung disease, heart disease, asthma, fever, hypertension, preeclampsia and eclampsia, cardiac arrhythmia Emergency Cesarean Eclampsia and Preeclampsia Multiple pregnancy Spinal anesthesia contraindications (high ICP, hypovolemia, anemia, coagulation disorders, etc.) History of allergy to eggs, soy, midazolam and propofol Use of antiemetic drugs
Age
From 18 years old to 46 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
We write two letters A and on two other sheets of letter B. We mix the papers together and put them in the drawer of the table.With each of the qualified patients, one of the papers is taken out randomly and, According to the text, the patient is given one of two groups: A (Propofol) and B (Midazolam). Then, for four subsequent patients, the paper is returned to the bag again, and this process is repeated until the end of the sample volume.
Blinding (investigator's opinion)
Double blinded
Blinding description
In both groups A and B, medications after spinal anesthesia one of two drugs (Propofol or Midazolam) will be prescribed.In order to prevent the medication being detectable for patients and investigators, they are prepared and injected into syringes of the same size and shape and on the adhesives A and B by the anesthetist. Since drugs are prescribed by an anesthetist, the clinician will not be aware of the type of prescribed medication that will measure and record the outcome of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Mahdieh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2019-08-10, 1398/05/19
Ethics committee reference number
IR.UMSHA.REC.1398.431

Health conditions studied

1

Description of health condition studied
sedation and nausea & vomiting during spinal anesthesia in cesarean section
ICD-10 code
T88.52
ICD-10 code description
Failed moderate sedation during procedure

Primary outcomes

1

Description
sedation
Timepoint
We record ramsy sedation score in 24 hours after surgery.‎
Method of measurement
Ramsy sedation score

2

Description
Nausea & vomiting
Timepoint
After surgery
Method of measurement
Observation

Secondary outcomes

1

Description
Systolic and Diastolic Blood Pressure
Timepoint
Every 5 minutes (from drug administration until end of surgery)
Method of measurement
Non-invasive automatic barometric device

2

Description
Heart Rate
Timepoint
Every 5 minutes (from drug administration until end of surgery)
Method of measurement
Using a pulse oximeter

Intervention groups

1

Description
Intervention group: : The amount of 0.2 mg/kg Propofol 1%(10mg/ml and made by B.BRAUN company in Germany), is injected intravenously after spinal anesthesia by anesthesiologist.
Category
Treatment - Drugs

2

Description
Intervention group: The amount of 0.02 mg/kg Midazolam(1mg/ml and made by Caspian pharmaceutical company in Iran), is injected intravenously after spinal anesthesia by anesthesiologist.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian, Anesthesiologist, Assistant Professor of Hamadan University Of Medical Sciences
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
hp.fatemieh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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