Protocol summary

Summary
The aim of this randomized double blind clinical trial is reducing usual dose of bupivacaine for spinal anesthesia by adding fentanyl. Can be reducing common side effects of bupivacaine (hypotension), this result in an appropriate level of anesthesia in patients. 105 pregnant women (18 to 40-year-old) candidate for elective cesarean section with spinal anesthesia entered the study. Who had singleton term pregnancies in class I physical health classification of the American Society of Anesthesia (ASA).And mothers with a history of hypertension, diabetes, cardiovascular and cerebral diseases, known fetal anomaly, any kind of contraindications for spinal anesthesia and those with difficult tracheal intubation were excluded. They were randomly divided into three groups of 35 women. The first group received 10 mg of bupivacaine 0.5%, the second received 8 mg of bupivacaine 0.5% with 25 microgram of fentanyl, and the third received 8 mg of bupivacaine 0.5% with 0.4 ml of normal saline Intrathecally. Blood pressure, heart rate, sensory level, degree of motor block, pain score during operation, nausea and vomiting, time taken to recover from sensory and motor block were measured and compared in three groups during and after surgery. Our data will be analyzed using the using t-test, Mann-Whitney test and Chi-square tests. A P value <0.05 will be considered statistically significant.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201704183305N8
Registration date: 2017-04-28, 1396/02/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-28, 1396/02/08
Registrant information
Name
Ebrahim Alijanpour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1228 0013
Email address
dralijanpour@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor Of Research Babol University Of Medical Sciences
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low dose Bupivacaine with fentanyl in spinal anesthesia for cesarean delivery to prevent maternal hypotension
Public title
The Effect Of Spinal Anesthesia Drug to Prevent Maternal Hypotention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: pregnant women, candidate for elective CS, in class I physical health classification of the American Society of Anesthesia (ASA). All women had singleton term pregnancies. Exclusion criteria: Mothers with a history of hypertension, diabetes, cardiovascular and cerebral diseases, known fetal anomaly, any kind of contraindications for spinal anesthesia, patients weighing over 100 kg and those with dificult tracheal intubation.
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: 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
Ethics committee of Babol University Of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol
City
Babol
Postal code
47176-41367
Approval date
2015-12-06, 1394/09/15
Ethics committee reference number
MUBABOL.REC.1394.232

Health conditions studied

1

Description of health condition studied
Maternal hypotension
ICD-10 code
O26.5
ICD-10 code description
maternal hypotension syndrome

Primary outcomes

1

Description
Maternal blood presure
Timepoint
Maternal blood pressure was monitored and recorded every two minutes for the first 15 minutes following spinal anesthesia, and then every 5 minutes until completion of surgery.
Method of measurement
Non invasive blood presure cuff

Secondary outcomes

1

Description
Sensory level and motor block
Timepoint
After spinal anesthesia
Method of measurement
Sensory level was assessed using the tip of a needle sterilized with alcohol cotton, and motor block was assessed and recorded using Bromage Scale (BS) (BS=0, full knee and foot flexion; BS=1, ability to move knee; BS=2, ability to move feet only; BS=3, full motor block).

2

Description
pain
Timepoint
Pain level during surgery
Method of measurement
VAS (Visual analogues Scale)

3

Description
Return of sensory and motor block
Timepoint
After Surgery
Method of measurement
Examination, Question & Observation

Intervention groups

1

Description
Control group: 10 mg 0.5% bupivacaine was injected into subarachnoid space.
Category
Prevention

2

Description
Intervention Group1: 8 mg of bupivacaine 0.5 with 25 micrograms of fentanyl was injected into subarachnoid space.
Category
Prevention

3

Description
Intervention Group2: 8 mg of bupivacaine 0.5% with 0.4 micrograms of Normal saline was injected into subarachnoid space
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rouhani Hospital of Babol
Full name of responsible person
Dr Hakimeh Alereza Amiri
Street address
Rouhani Hospital of Babol, Ganjafroz St.
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor research for Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Moghadamnia
Street address
Babol University Of Medical Sciences, Ganjafrooz street, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor research for Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr. Hakimeh Alereza Amiri
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
47176-41367
Phone
+98 11 3223 8284
Fax
Email
halereza@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr. Hakimeh Alereza Amiri
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
47176-41367
Phone
+98 11 3223 8284
Fax
Email
halereza@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University Of Medical Sciences
Full name of responsible person
Dr. Hakimeh Alereza Amiri
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Rouhani Hospital, Ganjafrooz Street, Babol
City
Babol
Postal code
47176-41367
Phone
+98 11 3223 8284
Fax
Email
halereza@yahoo.com
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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