Since, magnesium relaxant effect on muscular, we aimed to evaluate effect of intravenous magnesium sulfate infusion on intraoperative analgesia quality and muscle relaxation in patients undergo cesarean section with epidural analgesia. In current randomized double-blinded clinical trial, 66 women aged between 28 to 40 years old with term singleton pregnancy candidate for elective cesarean section with epidural analgesia will be enrolled and women suffering systemic diseases, mental disorders and body mass index more than 35 kilograms per meter square will be excluded.
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 during operation.
Study variables including patient’s analgesia grade and patient’s comfort grade will be asked from patients and questions considering muscle relaxation degree will be answered by surgeon. In addition, preoperative and post-operative patients’ body temperature will be measured. At the end of the operation, study solutions infusion will be discontinued and patient will be referred to post-anesthesia care unit (PACU) and sensory block and motor block duration and peri-operative complications will be recorded. In addition, intraoperative administration of supplement systemic anesthetics will be noted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610037013N14
Registration date:2016-10-11, 1395/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-10-11, 1395/07/20
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of magnesium sulfate infusion on muscle relaxation after spinal anesthesia for cesarean delivery
Public title
Magnesium sulfate effect on quality of epidural analgesia
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Sealed envelope method used for patients randomized assignment to study group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz Medical University
Street address
Vice chancellor for research, Tabriz university of medical sceinces, Daneshgah square
City
Tabriz
Postal code
Approval date
2016-10-27, 1395/08/06
Ethics committee reference number
IR.TBZMED.REC.1395.647
Health conditions studied
1
Description of health condition studied
Epidural analgesia quality
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery
Primary outcomes
1
Description
Muscle relaxation grade
Timepoint
during operation
Method of measurement
will be evaluated by surgeon
2
Description
patient's comfort grade
Timepoint
during operation
Method of measurement
will be answered by patients
3
Description
patient's analgesia grade
Timepoint
during operation
Method of measurement
verbal numeric scale
Secondary outcomes
1
Description
serum magnesium level
Timepoint
before operation, 24 hours after operation
Method of measurement
laboratory measurement
2
Description
sensory block duration
Timepoint
after surgery
Method of measurement
physical examination
3
Description
motor block duration
Timepoint
after surgery
Method of measurement
physical examination
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
Control group: Normal saline infusion in same volume of magnesium sulfate infused in study group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Women's Hospital
Full name of responsible person
Dr. Simin Atashkhoyi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Alireza Ostadrahimi
Street address
Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz Medical University
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
Tabriz Medical University
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Al Zahra hospital, Baghshomal square
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
atashkhoii@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz medical university
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Associate Professor, Specialist in anesthesiology
Other areas of specialty/work
Street address
Al Zahra hospital, Baghshomal square
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
atashkhoii@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Medical University
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Al Zahra hospital, Baghshomal square
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
atashkhoii@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)