Comparison of the effects of hyperbaric and isobaric bupivacaine on the Bispectral Index in parturients undergoing cesarean section with spinal anesthesia
The aim of this double-blinded randomized clinical trial was evaluation the efficacy of hyperbaric and isobaric bupivacaine on Bispectral Index in parturients undergoing elective cesarean section with spinal anesthesia. A total of 84 ASA physical status I-II women undergoing elective cesarean section with spinal anesthesia were randomized to 2 groups: 1- 2.5 cc hyperbaric bupivacaine 0.5%; 2- 2.5 cc isobaric bupivacaine 0.5%. All parturients receieved 10 ml/kg ringer lactate solution. Then spinal anesthesia was done in sitting position using 25 G sprotte needle. Participants were including parturients with ASA physical status I-II, scheduled for elective cesarean section, under spinal anesthesia and excluded with suspicious to bleeding disturbances, atopia, diabetes mellitus, presence of liver or kidney diseases, drugs abuse, complicated pregnancy and preeclampsia.
Bispecteral Index (BIS), signal quality index, electromyography and the temperature compared among the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201162405N9
Registration date:2012-01-29, 1390/11/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-29, 1390/11/09
Registrant information
Name
Mitra Jabalameli
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7472
Email address
jabalameli@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2009-06-27, 1388/04/06
Expected recruitment end date
2011-04-27, 1390/02/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of hyperbaric and isobaric bupivacaine on the Bispectral Index in parturients undergoing cesarean section with spinal anesthesia
Public title
The effects of hyperbaric and isobaric bupivacaine on the Bispectral Index in cesarean section with spinal anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Parturients; ASA physical status I-II; scheduled for elective cesarean section; using spinal anesthesia; Exclusion Criteria: suspicious to bleeding disturbances; atopia; diabetes mellitus; presence of liver or kidney diseases; drugs abuse; complicated pregnancy; preeclampsia
Age
From 15 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Vice-chancellor for Research, Ethics committee of Isfahan University of Medical Sciences
Street address
Vice-chancellor for Research, Gostaresh Building, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2009-07-20, 1388/04/29
Ethics committee reference number
22996
Health conditions studied
1
Description of health condition studied
Complications of anesthesia during pregnancy
ICD-10 code
O29.8
ICD-10 code description
Other complications of anesthesia during pregnancy
Primary outcomes
1
Description
Bispecteral Index
Timepoint
at the baseline ( 2 h before surgery) and then 5th, 10th, 15th, 30th, 45th, 60th, 90th and 120th minutes after spinal injection
Method of measurement
with attachment of probes of Cerebral Status Monitoring to the parturient
Secondary outcomes
1
Description
Signal Quality Index
Timepoint
at the baseline ( 2 h before surgery) and then 5th, 10th, 15th, 30th, 45th, 60th, 90th and 120th minutes after spinal injection
Method of measurement
with attachment of probes of Cerebral Status Monitoring to the parturient
2
Description
Electromyography
Timepoint
at the baseline ( 2 h before surgery) and then 5th, 10th, 15th, 30th, 45th, 60th, 90th and 120th minutes after spinal injection
Method of measurement
with attachment of probes of Cerebral Status Monitoring to the parturient
3
Description
Temperature
Timepoint
at the baseline ( 2 h before surgery) and then 5th, 10th, 15th, 30th, 45th, 60th, 90th and 120th minutes after spinal injection
Method of measurement
with tympanometer from the tympanic membrane
Intervention groups
1
Description
2.5 cc hyperbaric bupivacaine 0.5%. Duration of intervention: single dose in 10 seconds spinal injection. Duration of treatment: During spinal anesthesia in operating room
Category
Treatment - Drugs
2
Description
2.5 cc isorbaric bupivacaine 0.5%. Duration of intervention: single dose in 10 seconds spinal injection. Duration of treatment: During spinal anesthesia in operating room
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Medical Center
Full name of responsible person
Dr. Mitra Jabalameli
Street address
Pol fellezi
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Payman Adibi
Street address
Vice-chancellor for Research, Gostaresh Building, Isfahan University of Medical Sciences, Hezar Jarib St.
City
Isfahan
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, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mitra Jabalameli
Position
Specialist and Associate professor of Anesthesia and intensive care
Other areas of specialty/work
Street address
Department of Anesthesia and intensive care, Alzahra General Hospital, Sofe Boulevard
City
Isfahan
Postal code
Phone
+98 31162555551532
Fax
Email
jabalameli@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mitra Jabalameli
Position
Specialist and Associate professor of Anesthesia and intensive care
Other areas of specialty/work
Street address
Department of Anesthesia and intensive care, Alzahra General Hospital, Sofe Boulevard
City
Isfahan
Postal code
Phone
+98 31162555551532
Fax
Email
jabalameli@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mitra Jabalameli
Position
Specialist and Associate professor of Anesthesia and intensive care
Other areas of specialty/work
Street address
Department of Anesthesia and intensive care, Alzahra General Hospital, Sofe Boulevard
City
Isfahan
Postal code
772
Phone
+98 31162555551532
Fax
+98 31 1626 5773
Email
jabalameli@med.mui.ac.ir
Web page address
www.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)