Protocol summary

Summary
Objectives: To assess the effect of one and two minutes sitting position versus immediate trendelenburg position after spinal anesthesia on hemodynamic variables in patients who undergo elective cesarean section. Design: a double blinded randomized clinical trial. Setting and conduct: All eligible patients who are candidate for elective cesarean section who will refer to the Fatemieh Hospital during the study period will be enrolled in to the trial. Inclusion criteria: (a); candidate for elective cesarean section; (b) age of 14 to 45 years; (c) gestational age more than 36 weeks. Exclusion criteria: (a) having gestational blood pressure; (b) having diabetes. Intervention: (a) one min sitting position after spinal anesthesia with hyperbaric bupivacaine 0.5%; (b) two min sitting position after spinal anesthesia with hyperbaric bupivacaine 0.5%. Control: immediate trendelenburg position after spinal anesthesia with hyperbaric bupivacaine 0.5%. Primary outcome: (a) assessing systolic and diastolic blood pressure using automatic monitoring machine before surgery and at 1, 2, 3, 5 min after beginning of surgery and then every 5 min till 30 min after beginning of surgery and then every 10 min to the end of surgery; (b) measuring arterial oxygen saturation using pulse oximetry before, during and 30 min after surgery. Secondary outcome: assessing systemic reaction such as nausea, vomiting, shivering, itching, short breath, and vertigo during and 30 min after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409299014N42
Registration date: 2014-10-27, 1393/08/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-10-27, 1393/08/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of one and two minutes sitting position versus immediate trendelenburg position after spinal anesthesia on hemodynamic variables in patients who undergo elective cesarean section: a double blinded randomized controlled trial
Public title
Effect of one and two minutes sitting position versus immediate trendelenburg position after spinal anesthesia on hemodynamic variables in patients who undergo elective cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a); candidate for elective cesarean section; (b) age of 14 to 45 years; (c) gestational age more than 36 weeks. Exclusion criteria: (a) having gestational blood pressure; (b) having diabetes.
Age
From 14 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 65
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to the groups of intervention 1 and 2 and control group three paper sheets labeled A, B, and C. Blinding: The physician who will examine the patients will be unaware of the intervention. The analyzer will also unaware of intervention. Therefore, the trial will be run as double blinded.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
D/P/16/35/9/698

Health conditions studied

1

Description of health condition studied
elective cesarean section
ICD-10 code
O26.9
ICD-10 code description
Pregnancy-related condition, unspecified

Primary outcomes

1

Description
assessing systolic and diastolic blood pressure
Timepoint
before surgery and at 1, 2, 3, 5 min after beginning of surgery and then every 5 min till 30 min after beginning of surgery and then every 10 min to the end of surger
Method of measurement
using automatic monitoring machine

2

Description
measuring arterial oxygen saturation
Timepoint
before, during and 30 min after surgery
Method of measurement
using pulse oximetry

Secondary outcomes

1

Description
assessing systemic local reaction such as nausea, vomiting, shivering, itching, short breath, and vertigo
Timepoint
during and 30 min after surgery
Method of measurement
through physical examination and question

Intervention groups

1

Description
one min sitting position after spinal anesthesia with hyperbaric bupivacaine 0.5%
Category
Treatment - Other

2

Description
two min sitting position after spinal anesthesia with hyperbaric bupivacaine 0.5%
Category
Treatment - Other

3

Description
immediate trendelenburg position after spinal anesthesia with hyperbaric bupivacaine 0.5%
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Taiebeh Lotfi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Fatemieh Hospital
Full name of responsible person
Taiebeh Lotfi
Position
Medical student
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
00
Fax
Email
md_tayebe@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Pooran Hajian
Position
Anesthesiologist
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
00
Fax
Email
p_hajian48@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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