A Comparative Study on the Effect of Combined Fentanyl and Midazolam with Propofol Infusion on Blood Pressure and Heart Rate and Satisfaction of Cesarean Patients under Spinal Anesthesia
Objective: To compare the effect of combination of fentanyl and midazolam with propofol infusion on blood pressure and heart rate and satisfaction of patients with cesarean section under spinal anesthesia.
Design: Non-random-
Double-blind (patients and researchers no knowledge about drugs are used), uncontrolled, single-centered, stage two Clinical trials
Study population: Pregnant mothers who are selective and non-emergency for referral for cesarean section surgery and nominate spinal anesthesia
Main criteria for entering the study: Pregnant mothers who are selective and non-emergency candidates for cesarean section
Outcome criteria: having blood pressure, taking blood pressure lowering drugs, for maintaining hemodynamic status using drugs that increase blood pressure and heart rate
Sample size: 200
Intervention patients or interventions: intravenous fentanyl and midazolam infusion and propofol infusion to cesarean section under spinal anesthesia, spinal anesthesia with lidocaine 5% plus fentanyl
Intervention Time: Approximately 6 months Initial Outcome: It is expected that this study will be a better way to both cost and increase maternal satisfaction, as well as reduce stress and mental stress and mother's anxiety in the operating room.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701277745N6
Registration date:2017-07-07, 1396/04/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-07, 1396/04/16
Registrant information
Name
Afshin Mansourian
Name of organization / entity
YUMS
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0620
Email address
afshin.mansourian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Deputy of Research and Technology of Yasuj University of Medical Sciences
Expected recruitment start date
2016-11-30, 1395/09/10
Expected recruitment end date
2017-05-31, 1396/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparative Study on the Effect of Combined Fentanyl and Midazolam with Propofol Infusion on Blood Pressure and Heart Rate and Satisfaction of Cesarean Patients under Spinal Anesthesia
Public title
Spinal anesthesia in patients with cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion: Pregnant mothers who come to the operating room for non-emergency surgery to undergo surgery.
Exclusion: Patients with a history of diabetes, addiction, high blood pressure or antihypertensive drug use, and also at the time of surgery for maintaining hemodynamic status using drugs that increase blood pressure and heart rate
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The condition of the patient's comfort and forgiveness is examined from the incidents occurring in the operating room and during the operation of the cesarean section.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research and Technology
Street address
Yasuj University of Medical Sciences
City
Yasuj
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.YUNS.REC.1395.221
2
Ethics committee
Name of ethics committee
Deputy of Research and Technology
Street address
YUMS
City
Yasuj
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.YUMS.REC.1395. 221
Health conditions studied
1
Description of health condition studied
Spinal Anesthesia in pregnant patient
ICD-10 code
XV
ICD-10 code description
094-099
Primary outcomes
1
Description
heart rate and blood pressure
Timepoint
The patient's arrival time to the operating room, before the spinal anesthesia, every 10 minutes of badness for spinal anesthesia up to 60 minutes
Method of measurement
Using a blood pressure monitor and heart rate monitor
Secondary outcomes
1
Description
Satisfaction and a pleasant feeling by the mother
Timepoint
After the surgery and recovery time
Method of measurement
The question of patient
Intervention groups
1
Description
Spinal anesthesia: Lidocaine 5% at a dose of 75 mg at the start of C/S plus 50 micro-gram Fentanyl
Propofol: was infused at a rate of 8 mg per Kg/h
Fentanyl was infused at a rate of 0.5 micrograms per kilogram per hour plus midazolam at 0.05 mg per kilogram per hour
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Dr. Afshin Mansourian
Street address
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology
Full name of responsible person
Dr Hossein Ariad
Street address
YUMS
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Deputy of Research and Technology
Full name of responsible person
Dr Hossein Ariad
Street address
YUMS
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology
Proportion provided by this source
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
YUMS
Full name of responsible person
Afshin Mansourian
Position
Anesthesiologist / Assistant Professor
Other areas of specialty/work
Street address
Imam Sajjad Hospital
City
Yasuj
Postal code
Phone
+98 74 3322 0166
Fax
Email
afshin.mansourian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
YUMS
Full name of responsible person
Afshin Mansourian
Position
Anesthesiologist/Assistant Professor
Other areas of specialty/work
Street address
Imam Sajjad Hospital
City
Yasuj
Postal code
Phone
+98 74 3322 0166
Fax
Email
afshin.mansourian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
YUMS
Full name of responsible person
Afshin mansourian
Position
Anesthesiologist / Assistant Professor
Other areas of specialty/work
Street address
Imam Sajjad Hospital
City
Yasuj
Postal code
Phone
+98 74 3322 0166
Fax
Email
afshin.mansourian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)