During cesarean delivery the position of the patient may be particularly important because a different spread of the block may affect the incidence and severity of maternal hypotension. The aim of this study is to compare the maternal hemodynamic effects and side effects of intrathecally administered hyperbaric bupivacaine with fentanyl in the sitting or lateral decubitus position for placement of spinal needle during elective cesarean delivery. In this double-blind prospective study, 76 parturents aged 18-40 years and ASA class I, undergoing elective cesarean delivery are randomized to receive a hyperbaric, intrathecal solution of 10mg bupivacaine and 15µg fentanyl during spinal anesthesia induced in either the sitting or right lateral position. After an intrathecal injection using spinal technique patients is placed in the supine wedged position. Data collection is included sensory level, motor block, incidence and severity of hemodynamic changes, and vasoconstrictor use.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402017013N8
Registration date:2014-02-12, 1392/11/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-12, 1392/11/23
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice Chancellor of Tabriz University of Medical Sciences
Expected recruitment start date
2013-11-27, 1392/09/06
Expected recruitment end date
2014-08-27, 1393/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Position during Spinal Anesthesia for Cesarean section on Maternal Hemodynamics
Public title
Effect of Position during Spinal Anesthesia for Cesarean section on Maternal Hemodynamics
Purpose
Prevention
Inclusion/Exclusion criteria
In inclusion criteria: aged 18-40 years; scheduled for cesarean section; scheduled for spinal anesthesia
Exclusion criteria: gestational age 36 wk; History of systemic (cardiovascular, respiratory, renal , ...) or psychiatric disorders, hypertension(BP> 140/90 mmHG) Allergy to bupivacaine; contraindication for spinal anesthesia; emergency cesarean section, fetal problems(IUGR, Asphyxia,...)
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Vice Chancellor of Tabriz University of Medical Sciences
Street address
Research Vice Chanceller; Tabriz University; Daneshgah Street; Tabriz
City
Tabriz
Postal code
Approval date
2013-11-27, 1392/09/06
Ethics committee reference number
92137
Health conditions studied
1
Description of health condition studied
Hypotension after spinal anesthesia
ICD-10 code
I95.2
ICD-10 code description
Hypotension due to drugs
Primary outcomes
1
Description
Blood pressure
Timepoint
Baseline and every 2 minutes after spinal anesthesia to 10 min and then every 5 min to end of surgery
Method of measurement
mmHg
Secondary outcomes
1
Description
Total dose of vasoconstrictors
Timepoint
After spinal anesthesia to end of operation
Method of measurement
Doses of medicatins by mg or ug
Intervention groups
1
Description
In the study group (n=38) 0.5 % of hyperbaric bupivacaine 10 mg with fentanyl 15 µg during spinal anesthesia in lateral decubitos position is administered.
Category
Treatment - Drugs
2
Description
]n the control group (n=38) 0/5 ofhyperbaric bupivacaine 10 mg with fentanyl 15 µg during spinal anesthesia in sitting position is administered.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr. Simin Atashkhoyi
Street address
Alzahra Hospital, South Artesh Ave; Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice Chancellor, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Rashidi
Street address
Research Vice Chancellor, Tabriz University, Daneshgah Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice Chancellor, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Simin Atashkhoyi
Position
Anesthesiologist/Professor
Other areas of specialty/work
Street address
Al-Zahra Hospita, Sought Artesh Street, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)