The aim of this double-blinded randomized clinical trial was evaluation the efficacy of different dose of interatechal magnesium sulfate on quality of sensory-motor block in elective cesarean section. A total of 132 ASA physical status I-II women undergoing elective cesarean section with spinal anesthesia were randomized to four groups: 1- 2.5 cc Bupivacaine 0.5%+ 0.2cc Normal Saline; 2- 2.5 cc Bupivacaine 0.5%+ 0.1 cc Normal Saline+ 0.1 cc Magnesium sulfate 50%; 3 -2.5 cc Bupivacaine 0.5%+ 0.05 cc Normal Saline+ 0.15 cc Magnesium sulfate 50%; 4- 2.5 cc Bupivacaine 0.5%+ 0.2 cc Magnesium sulfate 50%. All parturients received 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, existence of liver or kidney diseases, drugs abuse, hypertension of pregnancy, preeclampsia. Sensory and motor onset time, duration of sensory and motor block compared among the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107112405N8
Registration date:2011-11-05, 1390/08/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-05, 1390/08/14
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
2010-08-23, 1389/06/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of different dose of interatechal magnesium sulfate on quality of sensory-motor block in elective cesarean section
Public title
The effect of interatechal magnesium sulfate on the quality of block in elective cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Parturients; ASA physical status I-II; scheduled for elective cesarean section; under spinal anesthesia; Exclusion Criteria: suspicious to bleeding disturbances; atopia; diabetes mellitus; existence of liver or kidney diseases; drugs abuse; hypertension of pregnancy; preeclampsia
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
132
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, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2010-04-20, 1389/01/31
Ethics committee reference number
389483
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
Sensory block onset time
Timepoint
time from intratechal injection to T6 dermatomal level
Method of measurement
pin prick test with needle
2
Description
motor block onset time
Timepoint
time from intratechal injection to ankle flexion
Method of measurement
ask to parturient for flexion of ankle- measure with watch in minute
3
Description
Duration of motor block
Timepoint
time from intrathecal injection to ability of ankle flexion
Method of measurement
with watch in minute
4
Description
Duration of sensory block
Timepoint
time from intrathecal injection to presence of pain
Visual Analogous Scale (VAS) and scoring from 0 to 10
Intervention groups
1
Description
2.5 cc Bupivacaine 0.5%+ 0.2cc Normal Saline. 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 Bupivacaine 0.5%+ 0.1 cc Normal Saline+ 0.1 cc Magnesium sulfate 50%. Duration of intervention: single dose in 10 seconds spinal injection. Duration of treatment: During spinal anesthesia in operating room
Category
Treatment - Drugs
3
Description
2.5 cc Bupivacaine 0.5%+ 0.05 cc Normal Saline+ 0.15 cc Magnesium sulfate 50%. Duration of intervention: single dose in 10 seconds spinal injection. Duration of treatment: During spinal anesthesia in operating room
Category
Treatment - Drugs
4
Description
2.5 cc Bupivacaine 0.5%+ 0.2 cc Magnesium sulfate 50. 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
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, 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
Phone
Fax
Email
jabalameli@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)