The effect of intrathecal injection rate of bupivacaine 0.5% on maternal sensory
level and hypotension during elective cesarean delivery under spinal anesthesia.
Spinal anesthesia with hyperbaric bupivacaine is an option that commonly used for elective cesarean delivery to reduce adverse effect of general anesthesia. The purpose of this study was to evaluate the influence of injection rate of bupivacaine 0.5% on anesthesia characteristics in parturient. Method: In this prospective study 75 term parturient allocated randomly to 3 groups according to rate of injection of 10 mg hyperbaric bupivacaine and 2.5 μg sufentanile with total volume of 3 ml; Group F (High injection rate,1ml/s ), Group S (Slow injection rate,0/04 ml/s) and Group M (Moderate injection rate, 0/2 ml/s). Primary outcomes are systolic and diastolic blood pressure, Heart rate, Sensory level and Motor level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122210841N2
Registration date:2013-02-03, 1391/11/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-03, 1391/11/15
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
School of Medicine, Hamadan University Of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-11-19, 1391/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intrathecal injection rate of bupivacaine 0.5% on maternal sensory
level and hypotension during elective cesarean delivery under spinal anesthesia.
Public title
Evaluation of drug injection rate on hypotension incidence during spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with ASA class 1&2; 18-40 years old; term pregnancy >37 week ; patients sheduled for elective cesarean section under spinal anesthesia. Exclusion criteria: Twin pregnancy ; emergency cesarean section ; pre-eclampsia; ecclampsia & maternal hypertension; cardiac disease; contraindications for spinal anesthesia (patients refusal, increase of ICP, skin infection, cuagulation disease, hypovolemia, previous neural problems and inexpert anesthesiologist)
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:
75
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
Hamadan University Of Medical Sciences
Street address
School of Medicine, Shahid Fahmide Street
City
Hamadan
Postal code
65178
Approval date
2012-12-15, 1391/09/25
Ethics committee reference number
3254/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Bupivacaine injection rate in spinal anesthesia
ICD-10 code
O29.5
ICD-10 code description
Other complications of spinal and epidural anaesthesia during pregnancy
Primary outcomes
1
Description
Systolic Blood Pressure
Timepoint
Systolic blood pressure was measured every 1 minute up to 15 minutes after spinal anesthesia.and every5 minutes up to 30 minutes and every 10 minutes up to end of surgery(60 minutes).
Method of measurement
using non invasive blood pressure monitoring
2
Description
Diastolic Blood Pressure
Timepoint
Diastolic blood pressure was measured every 1 minute up to 15 minutes after spinal anesthesia.and every5 minutes up to 30 minutes and every 10 minutes up to end of surgery(60 minutes).
Method of measurement
Non invasive Blood Pressure Monitoring
3
Description
Heart rate
Timepoint
Heart rate was measured every 1 minute up to 15 minutes after spinal anesthesia.and every5 minutes up to 30 minutes and every 10 minutes up to end of surgery(60 minutes).
Method of measurement
Pulse oximetry
4
Description
Sensory level
Timepoint
after spinal anesthesia and befor surgery
Method of measurement
With needle in anterior axillary line and bilateral.
5
Description
Motor level
Timepoint
After spinal anesthesia and befor surgery
Method of measurement
Observation & Examination and Bromage score(0 = no motor block, 1 = inability to raise the extended leg, 2 = inability to flex the knee, 3 = inability to flex the ankle)
Secondary outcomes
1
Description
Nausea
Timepoint
During surgery
Method of measurement
Observation
2
Description
Vomiting
Timepoint
during surgery
Method of measurement
Observation
3
Description
Efedrine Dosage
Timepoint
Ending of surgery
Method of measurement
Measurement of efedrine
Intervention groups
1
Description
Moderate group patients recieved 750 ml serum Ringer and anesthetized with spinal anesthesia in sitting position . 10 mg bupivacaine %0.5(2/5 ml)combined 0/5ml sufentanil(total volume=3ml) by 25 Gneedle in L3-L4 or L4-L5 space and injection rate (0/2 ml/second ) was injected.
Category
Prevention
2
Description
Fast group patients recieved 750 ml serum Ringer and anesthetized with spinal anesthesia in sitting position . 10 mg bupivacaine %0.5(2/5 ml)combined 0/5ml sufentanil(total volume=3ml) by 25 Gneedle in L3-L4 or L4-L5 space and injection rate (1ml/second )was injected.
Category
Prevention
3
Description
Slow group patients recieved 750 ml serum Ringer and anesthetized with spinal anesthesia in sitting position . 10 mg bupivacaine %0.5(2/5 ml)combined 0/5ml sufentanil(total volume=3ml) by 25 Gneedle in L3-L4 or L4-L5 space and injection rate (0/04 ml/second ) was injected.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemy Hospital
Full name of responsible person
Nahid Manouchehrian
Street address
Fatemy Hospital, Pasdaran Street
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research
Full name of responsible person
Dr. Heidar Tavilany
Street address
Hamadan university of medical science, School of Medicine, Fahmide Street
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
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
Hamadan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Assistant Professor Of Hamadan University of Medical Science