Protocol summary

Study aim
Comparison of sitting and lateral position during spinal anesthesia on maternal sensory block Level and hemodynamic effects in cesarean section.
Design
106 patients are randomly assigned into 4 blocks in a randomized, clinical trial, and in one of two positions, sitting and right lateral are under spinal anesthesia.
Settings and conduct
patients undergoing cesarean section at Fatemiyeh Hospital of Hamadan randomly placed in one of the two sitting and right-sided positions under spinal anesthesia and return immediately in supine position, and the vital signs and the maximum sensory level and onset time of anesthesia are evaluated by an assessment who does not know the patients' classification during spinal anesthesia.
Participants/Inclusion and exclusion criteria
Inclusin Criteria: parturients aged 18 to 45 years old; Candidates for cesarean section under spinal anesthesia; ASA Physical Class 1 and 2. Exclusion Criteria: Heart disease; Hypertension; Eclampsia & pre-eclampsia; Diabetes; Those who are reluctant to continue to participate in the study; Patients who have failed spinal anesthesia and undergo general anesthesia; Spinal anesthesia Contraindications (High ICP, coagulation problems, shock, anemia)
Intervention groups
After measuring the initial vital signs, the patients in group A are placed in a sitting position and patients in group B are placed in right lateral position and under spinal anesthesia by an anesthesiologist in L4-L3 space with a spinal quincke needle number 25. After aspiration of the cerebro spinal fluid, 10 mg of 0.5% bupivacaine and 0.5 ml of sufentanil are injected into the sub-arachnoid space, and the patient is placed immediately in the supine position and the vital signs will be registered.
Main outcome variables
Maximum sensory level; Onset time of anesthesia; Blood Pressure; Heart Rate; Nausea & Vomiting; Satisfaction; Atropine &Ephedrine dose

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120915010841N13
Registration date: 2019-03-04, 1397/12/13
Registration timing: registered_while_recruiting

Last update: 2019-03-04, 1397/12/13
Update count: 0
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sitting and lateral position during spinal anesthesia on maternal Sensory block Level and hemodynamics effect in cesarean section
Public title
The effect of Patient's position on post spinal anesthesia hypotension
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
parturients aged 18 to 45 years old Candidates for cesarean section under spinal anesthesia ASA Physical Class 1 and 2
Exclusion criteria:
Heart disease Hypertension Eclampsia & pre-eclampsia Diabetes Those who are reluctant to continue to participate in the study Patients who have failed spinal anesthesia and undergo general anesthesia Spinal anesthesia Contraindications (High ICP, coagulation problems, shock, anemia)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 106
Randomization (investigator's opinion)
Randomized
Randomization description
In this study , a randomized block design with four replications is used. we provide four paper sheets . We write two letters A and on two other sheets of letter B. We mix the papers together and put them in the drawer of the table.With each of the qualified patients, one of the papers is taken out randomly and will be assigned to one of the two sitting or lateral position groups, depending on whether the drawn sheet is either A or B. After the random drawn out of four sheets, all the papers will be returned to the drawer and again the above procedure will continue for the next four patients until it reaches the sample volume.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients in Group A are in the sitting position and patients in Group B are placed in the right lateral position and they are under spinal anesthesia by anesthesiologist .Then the patients are immediately placed in supine position and evaluate by assessing who does not know the patients' classification and status of patients during spinal anesthesia in the two groups that analyzes the outcomes.In this study, the evaluator and analyzer do not know the type of patient s position drug spinal anesthsia.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan university of medical sciences
Street address
Mahdieh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2018-09-01, 1397/06/10
Ethics committee reference number
IR.UMSHA.REC.1397.414

Health conditions studied

1

Description of health condition studied
Hypotension & sensory block level during spinal anesthesia under different positions in c/s
ICD-10 code
074.6
ICD-10 code description
En Other complications of spinal and epidural anaesthesia during labour and delivery

Primary outcomes

1

Description
Maximum sensory level
Timepoint
Every minute to 5 minutes
Method of measurement
Determination of sensory level by needle (Pinprick)

2

Description
Onset time of sensory block
Timepoint
Every minute until the sensory block is fixed
Method of measurement
In minutes using the clock

3

Description
Systolic and Diastolic Blood Pressure
Timepoint
Every two minutes for 10 minutes and then every 10 minutes to 60 minute
Method of measurement
Non-invasive automatic barometric device

4

Description
Heart Rate
Timepoint
Every two minutes for 10 minutes and then every 10 minutes to 60 minute
Method of measurement
Non-invasive automatic barometric device

Secondary outcomes

1

Description
Nausea and Vomiting
Timepoint
During surgery
Method of measurement
View and ask the patient

2

Description
satisfaction
Timepoint
End of surgery
Method of measurement
Question from the patient

3

Description
Need for ephedrine
Timepoint
End of surgery
Method of measurement
Calculate consumed ephedrine

4

Description
Need for atropine
Timepoint
End of surgery
Method of measurement
Calculate consumed atropine

Intervention groups

1

Description
Control group: After measuring and recording the initial vital signs, the patients in group A are placed in a sitting position and under spinal anesthesia by an anesthetist in L4-L3 (mid line) with a spinal quincke needle number 25. After aspiration of the cerebro spinal fluid, 10 mg (2 ml) of 0.5% bupivacaine and 0.5 ml of sufentanil are injected into the sub-arachnoid space, and then the patient is placed immediately in the supine position and the vital signs will be registered.
Category
Prevention

2

Description
Intervention group: After measuring and recording the initial vital signs, the patients in group B are placed in a right lateral position and under spinal anesthesia by an anesthetist in L4-L3 (mid line) with a spinal quincke needle number 25. After aspiration of the cerebro spinal fluid, 10 mg (2 ml) of 0.5% bupivacaine and 0.5 ml of sufentanil are injected into the sub-arachnoid space, and then the patient is placed immediately in the supine position and the vital signs will be registered.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemy Hospital
Full name of responsible person
Nahid Manouchehrian, Anesthesiologist, Assistant Professor of Hamadan University Of Medical Sciences
Street address
Fatemy Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
hp.fatemieh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manuchehriann@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manuchehriann@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manuchehriann@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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