Protocol summary

Summary
This study is a double blind clinical trial. One hundred patients admitted for non-emergency cases to Taleghani hospital in Arak. Inclusion criteria: ASA I, II, age: 20-35, BMI: nineteen to twenty-six Exclusion criteria: fetal distress, symptoms for start delivery, multiple pregnancy , hypertension, preeclampsia, intrauterine growth restriction, contraindication for spinal anesthesia, polyhydramnius, macrosomia. In first, researcher obtained demographic information and vital signs and arterial oxygen saturation from all patients. Then, researcher injected Ringer serum 10 ml per kg and 10 mg Metoclopramide and 50 mg Ranitidine, as premedication 15 minutes before surgery. Patients were allocated randomly (simple random) into two groups (pelvic tilt and tilt beds by 15 degrees). Spinal anesthesia was done in the space between the vertebrae of the L3-L4 or L4-L5 with needle 26 and 12.5 mg of Buivacaine injected in 15 seconds in the subarachnoid space. The patients were divided according to their group‘s position. Sensational block was investigated every 1 min after anesthesia and motor block measured by Bromeg scale. Time of sensational block were recorded in T10 and highest Dermatomes block in 15 minutes. Mean arterial blood pressure, heart rate and arterial oxygen saturation were measured every 5 minutes to end of surgery. The fetal Apgar scores were recorded at first and fifth minute after delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121325509N1
Registration date: 2016-01-04, 1394/10/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-04, 1394/10/14
Registrant information
Name
Ali Khanidokht
Name of organization / entity
Arak University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
a.khanidokht@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences and Health Services
Expected recruitment start date
2015-12-15, 1394/09/24
Expected recruitment end date
2017-12-15, 1396/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison position of tilt of Pelvic and position of tilt of Position in intrauterine resuscitation during spinal anesthesia for cesarean section
Public title
Effect of position during spinal anesthesia for cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA I, II, age 20-35, BMI nineteen to twenty-six Exclusion criteria: fetal distress, symptoms for start delivery, multiple pregnancy , hypertension, preeclampsia, intrauterine growth restriction, contraindication for spinal anesthesia, polyhydramnius, macrosomia
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In blindness patient and analyzer do not know information of classification of groups. Randomization done two groups by random number method.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences and Health Services
Street address
Research Center, Payambar azam educational complex , Basij square, Sardasht
City
Arak
Postal code
38481-7-6941
Approval date
2015-06-29, 1394/04/08
Ethics committee reference number
IR.ARAKMU.REC.1394.70

Health conditions studied

1

Description of health condition studied
Intrauterine Resuscitation during Spinal Anesthesia for Caesarian Section
ICD-10 code
O82.0
ICD-10 code description
Delivery by elective caesarean section

Primary outcomes

1

Description
arterial blood pressure
Timepoint
Every five minutes after intervention until end of surgery
Method of measurement
Barometer

2

Description
Heart rate
Timepoint
Every 5 minutes after intervention until end of surgery
Method of measurement
Pulse counting

3

Description
Arterial oxygen saturation
Timepoint
Every 5 minutes after intervention until end of surgery
Method of measurement
Pulse oximetry

4

Description
Apgar in neonate
Timepoint
First and fifth minute after end of surgery
Method of measurement
Apgar questionnaire

5

Description
Time of sensational block in T10
Timepoint
15 minutes after intervention
Method of measurement
chronometer

6

Description
time of Highest Dermatomes block
Timepoint
15 minutes after intervention
Method of measurement
chronometer

Secondary outcomes

empty

Intervention groups

1

Description
patient lying supine and a pillow placed under the right hip .it is 15 degrees of tilt of pelvic of patient.
Category
Treatment - Other

2

Description
researcher will put tilt angle of bed to 15 degrees to left
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr Ali Khanidokht
Street address
Emam Khomeini street
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences and Health Services
Full name of responsible person
Dr Mohammad Rafiee
Street address
Research Center, Payambar azam educational complex, Basij square, Sardasht
City
Arak
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, Arak University of Medical Sciences and Health Services
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
Arak University of Medical Sciences and Health Services
Full name of responsible person
Dr Ali Khanidokht
Position
Resident of Anesthesia
Other areas of specialty/work
Street address
Research Center, Payambar azam educational complex, Basij square, Sardasht
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3417 3524
Fax
Email
a.khanidokht@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Dr Hoshang Talebi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Valiasr Hospital
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3417 3524
Fax
Email
a.khanidokht@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Dr Ali Khanidokht
Position
Resident of anesthesia
Other areas of specialty/work
Street address
Research Center, Payambar azam education complex, Basij square, Sardasht
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3417 3524
Fax
Email
a.khanidokht@arakmu.ac.ir
Web page address

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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