Protocol summary
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Study aim
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Effect of Magnesium Sulfate Infusion on Muscle Relaxation after Spinal Anesthesia for Cesarean Delivery
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Design
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Randomised, double blinded clinical trial, randomisation was promoted by the method of randomly permuted blocks using Rand software
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Settings and conduct
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The randomized clinical trial study will conducted on 66 women aged between 18 to 40 years old with term singleton pregnancy candidate for elective cesarean section with epidural analgesia at Al-Zahra hospital of Tabriz University in the period of April 6th, 2017 to September 20th, 2017.Prior to surgery, equally patients will be divided to control and study groups. In operation room, epidural analgesia will be induced in L3-4 or L4-5 intervertebral spaces. Subsequent to delivery and umbilicus clamping, in study group 15 milligrams per kilograms’ magnesium sulfate will be infused till end of the operation and in control group same volume of normal saline will be infused.This study will be double blind in which physician and patients are blind to treatment protocols.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria included term parturient with ASA I or II, 18-40 years age, scheduled for elective cesarean section with spinal anesthesia. Exclusion criteria included parturient who needed emergency cesarean section, had co-existing systemic diseases,any history of psychological disorder, obesity of BMI>35, history of calcium channel blockers use, recent magnesium consumption, contraindication of spinal anesthesia.
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Intervention groups
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After neonate delivery in the study group, magnesium sulfate (15 mg kg-1 in 100 ml 0.9% saline) was infused over 15 minutes. Then, 15 mg/kg/hr. of magnesium sulfate were infused until the end of the surgery. In the placebo group, the same volume of 0.9% saline was infused
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Main outcome variables
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Motor Relaxation
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201610037013N14
Registration date:
2016-10-11, 1395/07/20
Registration timing:
prospective
Last update:
2019-07-13, 1398/04/22
Update count:
1
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Registration date
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2016-10-11, 1395/07/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Investigator
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Expected recruitment start date
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2017-04-06, 1396/01/17
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Expected recruitment end date
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2017-09-20, 1396/06/29
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Actual recruitment start date
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2017-04-06, 1396/01/17
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Actual recruitment end date
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2017-09-20, 1396/06/29
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Trial completion date
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2017-09-20, 1396/06/29
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Scientific title
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Effect of magnesium sulfate infusion on muscle relaxation after spinal anesthesia for cesarean delivery
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Public title
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Magnesium sulfate effect on quality of epidural analgesia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
class I or II in American society of anesthesiology;
aged between 18-40 years old;
term pregnancy;
singleton pregnancy;
candidate for elective cesarean section;
candidate for epidural analgesia.
Exclusion criteria:
emergent cesarean section;
systemic diseases (renal, cardiac, pulmonary, hepatic, neuromuscular and etc.)
mental disorders
body mass index more than 35 kilograms per meter square;
calcium channel blockers usage
recent use of magnesium;
contraindications for epidural analgesia.
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
66
Actual sample size reached:
66
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will promoted by the method of randomly permuted blocks using Rand software (Rand list online).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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This study will be double blind in which physician and patients are blind to treatment protocols.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Sealed envelope method used for patients randomized assignment to study group
Ethics committees
1
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Ethics committee
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Approval date
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2016-10-27, 1395/08/06
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Ethics committee reference number
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IR.TBZMED.REC.1395.647
Health conditions studied
1
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Description of health condition studied
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Epidural analgesia quality
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ICD-10 code
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O74.6
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ICD-10 code description
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Other complications of spinal and epidural anaesthesia during labour and delivery
Primary outcomes
1
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Description
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Muscle relaxation grade
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Timepoint
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during operation
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Method of measurement
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will be evaluated by surgeon
2
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Description
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patient's comfort grade
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Timepoint
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during operation
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Method of measurement
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will be answered by patients
3
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Description
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patient's analgesia grade
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Timepoint
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during operation
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Method of measurement
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verbal numeric scale
Secondary outcomes
1
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Description
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serum magnesium level
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Timepoint
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before operation, 24 hours after operation
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Method of measurement
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laboratory measurement
2
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Description
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sensory block duration
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Timepoint
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after surgery
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Method of measurement
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physical examination
3
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Description
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motor block duration
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Timepoint
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after surgery
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Method of measurement
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physical examination
Intervention groups
1
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Description
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Study group: 15 milligrams per kilograms’ (approximately 1 gram) magnesium sulfate infusion in 100 milliliters normal saline serum during 15 minutes and subsequently, 15 milligrams per kilograms per hour (approximately 1 gram per hour) infusion till end of the operation.
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Category
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Treatment - Drugs
2
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Description
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Control group: Normal saline infusion in same volume of magnesium sulfate infused in study group.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz Medical University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available