Compare the effects of intrathecal hyperbaric Bupivacaine injected at different doses in combination with a fixed dose of Sufentanil in Cesarean section
For compare the effects of intrathecal hyperbaric Bupivacaine injected at different doses in combination with a fixed dose of Sufentanil in Cesarean section, in a double blind clinical trial after obtaining the consent of the patients, 105 patients undergoing caesarean section randomly using Blocks randomized into three groups: A (8mg bupivacaine 0.5% hyperbaric), B (9mg bupivacaine 0.5% hyperbaric) and C (10mg bupivacaine 0. 5% hyperbaric) at each 2.5 micg as adjuvant added Sufentanil, and we split these drugs for spinal anesthesia may apply. The maximum Sensory and Motor Block, Quality of Analgesia during surgery and complications (Nausea, Vomiting, Hypotension, Bradycardia, and Itching) determined in all three groups, we recorded and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010931852N1
Registration date:2017-03-11, 1395/12/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-11, 1395/12/21
Registrant information
Name
Mahzad Alimian
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
alimian.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chanceler for research, Iran university of medical sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-01-29, 1395/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effects of intrathecal hyperbaric Bupivacaine injected at different doses in combination with a fixed dose of Sufentanil in Cesarean section
Public title
Compare the effects of intrathecal hyperbaric Bupivacaine injected at different doses in combination with a fixed dose of Sufentanil in Cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Not Preeclampsia; ASA<3; Gestational age>36weeks; Not twain; Height>150cm; Not addiction; Not spinal block contraindication
Exclusion criteria: Spinal block technical problems
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
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
Ethic Committee of Iran University of Medical Science
Street address
Hemmat highway
City
Tehran
Postal code
Approval date
2015-04-26, 1394/02/06
Ethics committee reference number
IR.IUMS.REC.1394.د/۱۰۵/۴۶۸
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
082
ICD-10 code description
Caesarean section
Primary outcomes
1
Description
Sensory block level
Timepoint
Every 5 minutes
Method of measurement
Pin prick test
2
Description
Motor block level
Timepoint
Every 5 minutes
Method of measurement
Bromage score
Secondary outcomes
1
Description
Nausea
Timepoint
Operation time and Recovery
Method of measurement
Patient statement
2
Description
Vomiting
Timepoint
Operation time and Recovery
Method of measurement
Patient status
3
Description
Itching
Timepoint
Operation time and Recovery
Method of measurement
Patient statement
4
Description
Hypotention
Timepoint
Every 5 minutes
Method of measurement
Non Invasive Blood Pressure measuring
5
Description
Bradycardia
Timepoint
Every 5 minutes
Method of measurement
Pulseoxymetery
Intervention groups
1
Description
A: Intratechal injection of 8 mg hyperbaric Bupivacaine with 2.5 micg Sufentanil
Category
Treatment - Drugs
2
Description
B: Intratechal injection of 9 mg hyperbaric Bupivacaine with 2.5 micg Sufentanil
Category
Treatment - Drugs
3
Description
C: Intratechal injection of 10 mg hyperbaric Bupivacaine with 2.5 micg Sufentanil
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool akram Hospital
Full name of responsible person
Alireza Rajabi
Street address
Shahrara ave
City
Tehran
2
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Alireza Rajabi
Street address
Vali e asr sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for search,Iran University of Medical Science
Full name of responsible person
Alimian Mah zad
Street address
Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for search,Iran University of Medical Science
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
Iran University of Medical Science
Full name of responsible person
Rajabi Alireza
Position
Medical Assistant
Other areas of specialty/work
Street address
Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
rajabi.email@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Alimian Mah zad
Position
Professor Assistant/Anethesia
Other areas of specialty/work
Street address
Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
alimian.m@iums.ac.ir;mahzadalimian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Rajabi Alireza
Position
Medical Assistant
Other areas of specialty/work
Street address
Hemmat Highway
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)