Effect of prophylactic administration of two doses of magnesium sulfate on cardiovascular changes during general anesthesia in Gynecologic laparoscopic surgery compared with women in the placebo group attending
This study aimed to evaluate the effect of two doses of magnesium sulphate on cardiovascular changes during general anesthesia in laparoscopic surgeries of women.
Design
Groups and their number were determined by the anesthetist nurse who did not play a role in study.In the days that me was in hospital and was a woman's laparoscopic surgery, she presented a 50-cc syringe to me for injection that contained either 30 mg magnesium sulfate, 50 or without sulfate. after inject, i write the Symptoms of the patient and then back the form to the nurse for write the dose of sulfate magnesium and archives form.
Settings and conduct
The place of the study was Shahid Beheshti Hospital and Alzahra Hospital in Isfahan.
Groups and their number were determined by the anesthetist nurse who did not play a role in study.In the days that me was in hospital and was a woman's laparoscopic surgery, she presented a 50-cc syringe to me for injection that contained either 30 mg magnesium sulfate, 50 or without sulfate. after inject, i write the Symptoms of the patient and then back the form to the nurse for write the dose of sulfate magnesium and archives form.
Participants/Inclusion and exclusion criteria
Candidate for laparoscopic surgery for women including ASA patients 1 and 2
Intervention groups
Patients were divided into three groups of placebo (p): 36; the group receiving 30 mg / kg magnesium sulfate (M1) was 35 and the group receiving 50 mg / kg magnesium sulfate (M2) was divided into 35
Main outcome variables
Changes in blood pressure, changes in heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190105042236N1
Registration date:2019-02-10, 1397/11/21
Registration timing:retrospective
Last update:2019-02-10, 1397/11/21
Update count:0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
Mona Mostashfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3267 9440
Email address
amirmostashfi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
2016-10-22, 1395/08/01
Actual recruitment end date
2017-05-20, 1396/02/30
Trial completion date
2017-05-20, 1396/02/30
Scientific title
Effect of prophylactic administration of two doses of magnesium sulfate on cardiovascular changes during general anesthesia in Gynecologic laparoscopic surgery compared with women in the placebo group attending
Public title
Effect of prophylactic administration of magnesium sulfate on cardiovascular changes during general anesthesia in Gynecologic laparoscopic surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients ASA 1
Patients ASA 2
Women Laparoscopic Surgery
Outer uterus and endometriosis and diagnosis (infertility)
Maximum operating time is 150 minutes
Exclusion criteria:
High blood pressure
Sensitization to magnesium sulfate
Heart block
Emergency situation
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
100
Actual sample size reached:
106
Randomization (investigator's opinion)
Randomized
Randomization description
This study was performed on patients who underwent surgery in Shahid Beheshti and Alzahra Hospitals in Isfahan during the study days as a simple randomized method.So that the syringes of the drug studied by the anesthetist nurse who did not play a role in the data were fill up during the study of the performed surgical operations with a volume of 50 cc(This 50 cc contain 30 cc dose of sulfate or contain 50 cc dose of sulfate or neutral and there was a dose that the injector who was a slave or someone else did not know about this agent)
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was performed on patients who underwent surgery in Shahid Beheshti and Alzahra Hospitals in Isfahan during the study days as a simple randomized method.So that the syringes of the drug studied by the anesthetist nurse who did not play a role in the data were fill up during the study of the performed surgical operations with a volume of 50 cc(This 50 cc contain 30 cc dose of sulfate or contain 50 cc dose of sulfate or neutral and there was a dose that the injector who was a slave or someone else did not know about this agent)
Effect of prophylactic administration of two doses of magnesium sulfate on cardiovascular changes during general anesthesia in Gynecologic laparoscopic surgery
ICD-10 code
E61.2
ICD-10 code description
Magnesium deficiency
Primary outcomes
1
Description
Change of systolic blood pressure
Timepoint
before the induction of anesthesia as a base and after the anesthesia were measured and recorded after the finishing of the infused medication. These parameters were measured and recorded immediately before the pneumoperitoneum and 5, 10, 20, 30,40 minutes After pneumoperitoneum.
Method of measurement
Barometer
2
Description
Change of heart rate
Timepoint
before the induction of anesthesia as a base and after the anesthesia were measured and recorded after the finishing of the infused medication. These parameters were measured and recorded immediately before the pneumoperitoneum and 5, 10, 20, 30,40 minutes After pneumoperitoneum.
Method of measurement
Pulse oximeter
Secondary outcomes
1
Description
The amount of chills and vomiting
Timepoint
After the recovery
Method of measurement
Objective observation and question
Intervention groups
1
Description
Intervention group: Magnesium sulfate at a dose of 30 mg / kg
Category
Prevention
2
Description
Intervention group: Magnesium sulfate at a dose of 50 mg / kg