In this double-blind randomized clinical trial, 90 patients, candidate for lower extremities surgeries in a training hospital, were recruited. The patients with ASA class I and II aging from 20 to 65 years between 2009 and 2010 were evaluated. The selected patients were randomly assigned to receive either bupivacaine alone (Group A, n=30), or bupivacaine plus magnesium sulphate 50% (Group B, n=30), or bupivacaine plus neostigmine (Group C, n=30). The sensory block onset, top level of sensory block, motor block onset, and the completion of motor block and recovery were recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012071910336N1
Registration date:2012-08-15, 1391/05/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-15, 1391/05/25
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 4036
Email address
p_rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Vice- Chancellor for research
Poorsina St, Enghelab Ave, Tehran university of medical science
Expected recruitment start date
2010-02-24, 1388/12/05
Expected recruitment end date
2011-11-15, 1390/08/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of adding intrathecal neostigmine or magnesium sulphate to bupivacaine in patients under lower extremities surgeries.
Public title
Effects of adding intrathecal neostigmine or magnesium sulphate to bupivacaine in patients under lower extremities surgeries.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:The inclusion criteria were patients between 20-65 years who were candidates for lower extremity surgeries and signed informed consent.
Exclusion criteria: local infection; hemorrhagic disorders; drug hypersensitivity; muscular disorders ; central and peripheral neuropathy; drug abuse history and addiction.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical scinces
Street address
16 Azar St. pardis poor sina
City
Tehran
Postal code
15168
Approval date
2009-08-20, 1388/05/29
Ethics committee reference number
1515
Health conditions studied
1
Description of health condition studied
Contusion of other and unspecified parts of foot
ICD-10 code
S90.3
ICD-10 code description
Contusion of other and unspecified parts of foot
Primary outcomes
1
Description
Sensory block onset
Timepoint
Every 30 second
Method of measurement
Second
Secondary outcomes
1
Description
Recovery of sensory block
Timepoint
Every 5 minute
Method of measurement
Minute
Intervention groups
1
Description
magnesium sulphate 50% Pasteur Institute, Tehran, Iran, singel dose Intrathecal.