In this study the effect of intrathecal sulfate magnesium on duration of motors & sensory block was evaluated. Design: Duble blind clinical trial. Setting: Patients were divided into two groups randomly Bupivacaine - Sulfate magnesium and Bupivacaine alone. All patients was given serum ringer 500ml before spinal anesthesia. Inclusion criteria: eighty ASA class I,II full term pregnant women who require for elective cesarean section. Exclusion criteria:Patients with a history of cardiovascular disease; psychiatric; chronic pain; dependent on drugs and alcohol; HTN; DM and other systemic disease. Intervention: Patients were randomly allocated to receive intrathecally either 10mg Hyperbaric Bupivacaine plus 0.1ml(50mg) sulfate magnesium 50% or 10mg Hyperbaric Bupivacaine plus 0.1ml N/S 0.9% Main outcomes:BP, HR, Nausea & vomiting, duration of sensory & motor block.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312124923N5
Registration date:2014-01-02, 1392/10/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-02, 1392/10/12
Registrant information
Name
Bahman Hasannasab
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
bahmanh2002@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellor Of Research Babol University Of Medical Sciences
Expected recruitment start date
2003-12-22, 1382/10/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the sensory and motor blockade duration of intrathecal, Bupivacaine-Sulfate Mg and Bupivacaine alone
Public title
A comparison of the sensory and motor blockade duration of intrathecal, Bupivacaine-Sulfate Mg and Bupivacaine alone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA class I,II; Height 160 to 180 cm; candidates for elective caesarean section; gestational age over 39 weeks
Exclusion criteria: Patients with a history of cardiovascular disease; psychiatric; chronic pain; dependent on drugs and alcohol; HTN; DM and other systemic disease.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Approval date
2013-12-21, 1392/09/30
Ethics committee reference number
3480/30/ژ/پ
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
O74
ICD-10 code description
Complications of anaesthesia during labour and delivery
Primary outcomes
1
Description
Evaluation of Sensory block duration
Timepoint
Sensory block level evaluated every 30 second until 15 minutes and then 5 minutes until sensory block off
Method of measurement
Needle No 20
2
Description
Evaluation of motor block duration
Timepoint
motor block level evaluated every 30 second until 15 minutes and then 5 minutes until motor block off
Method of measurement
Bromage scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
0, 1, 3, 6, 9, 12, 15, 18 and 21 min
Method of measurement
Non Invasive BP
2
Description
Heart rate
Timepoint
0, 1, 3, 6, 9, 12, 15, 18 and 21 min
Method of measurement
ECG
3
Description
Analgesia
Timepoint
first 24 hours after spinal
Method of measurement
VAS
Intervention groups
1
Description
Intervention group: Patients were randomly allocated to receive intrathecally either 10mg Hyperbaric Bupivacaine plus 0.1ml(50mg) sulfate magnesium 50%
Category
Treatment - Drugs
2
Description
Control group:Patients with 10 mg Intrathecal Bupivacaine with 0.1 ml of normal saline is injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Dr Bahman hasannasab
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor Of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
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 Of Research 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 Bahman Hasannasab
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
bahmanh2002@yahoo.com؛ ans_dep@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 Bahman Hasannasab
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
bahmanh2002@yahoo.com؛ ans_dep@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 Bahman Hasannasab
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)