Study of the effect of magnesium sulfate 25 mg/kg & 50 mg/kg, on the speed of onset & intensity of muscle relaxation of cisatracurium during induction of anesthesia in the patients candidate for laparatomy
This double blind randomized control trial, conducted to assess the effect of magnesium sulfate on the speed & potency of cisatracorium in muscle relaxation. 90 patients between 18 - 80 years old with ASA class I, II who were candidate for elective abdominal surgery were selected for this study. All patients who had history of any neuromuscular or metabolic and systemic diseases were excluded. They were divided to three groups randomly. Before giving any anesthetic drug, in the group 1, normal saline 100 cc as placebo. Magnesium sulfate 25 & 50 mg/kg dissolved in 100 cc normal saline infused respectively during 10 min in 2nd and third group. Anesthesia was induced with standard and equal dose of midazolam, fentanyl & thiopantal in all patients. For muscle relaxation 0.15 mg/kg cisatracorium with priming method was used. The speed of relaxation was evaluated with single twitch test and with the help of nerve stimulator. 3 min after muscle relaxant the patients were intubated. The potency of muscle relaxation checked with post tetanic count test (PTC) every 5 min until 30 min after intubation. Vital signs (HR & MAP) were measured and printed in the time curse of the study every 5 min also.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012135378N1
Registration date:2011-04-20, 1390/01/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-20, 1390/01/31
Registrant information
Name
Mohammad Reza Ghodraty
Name of organization / entity
Tehran Univercity of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 2818
Email address
mgodraty@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Medicine Faculty of Iran (Tehran) University of Medical Sciences
Expected recruitment start date
2009-12-20, 1388/09/29
Expected recruitment end date
2010-12-20, 1389/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of magnesium sulfate 25 mg/kg & 50 mg/kg, on the speed of onset & intensity of muscle relaxation of cisatracurium during induction of anesthesia in the patients candidate for laparatomy
Public title
The effect of magnesium on muscular relaxation with cisatracorium
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ASA I,II physical status class; 18 -60 years old; candidate for elective intra abdominal surgery under general anesthesia
Exclusion criteria:
History of neuromuscular, kidney, hepatic and cardiac diseases; hypo or hyper metabolic diseases; and those consuming drugs that affect neuromuscular junction; & history of cardiac arrhythmias.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
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
Ethics Committee of Medicine Faculty of Iran University of Medical Sciences (Tehran)
Street address
Medicine Faculty, Hemmat Pardise, Hemmat Freeway.
City
Tehran
Postal code
Approval date
2009-06-21, 1388/03/31
Ethics committee reference number
43102
Health conditions studied
1
Description of health condition studied
Elective intra abdominal surgery ( General & Gynecologic)
ICD-10 code
Y83.9
ICD-10 code description
Surgical procedure, unspecified
Primary outcomes
1
Description
Speed of muscle relaxation
Timepoint
After intervention
Method of measurement
Every second with nerve stimulator and single twitch test
Secondary outcomes
1
Description
Quality & depth of muscle relaxation
Timepoint
5 min after intervention
Method of measurement
Every 5 min with nerve stimulator and by post tetanic count test
2
Description
Heart rate & blood pressure variation
Timepoint
From arrival of the patient to OR until 30 min after intervention
Method of measurement
Every 5 min
Intervention groups
1
Description
In the control group a single shut 100cc normal saline as placebo before induction of anesthesia.
Category
Placebo
2
Description
In the first group of intervention ( group 2 study) 25 mg/kg magnesium sulfate dissolved in 100cc normal saline infused intravenously over 10 min before anesthesia as single dose
Category
Treatment - Drugs
3
Description
In the second group (group 3 study) 50 mg/kg magnesium sulfate dissolved in 100cc normal saline infused in 10 min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Mohammad Reza Ghodraty MD, Assistant Professor of Anesthesia
Street address
Behafarin St, Karim Khan AV.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Medicine Faculty, Iran University of Medical Scienses (Tehran)
Full name of responsible person
Seyed Ali Javadmousavi MD.
Street address
3th floor, Research Deputy of Medicine Faculty, Hemmat Pardis, Hemmat Freeway.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Medicine Faculty, Iran University of Medical Scienses (Tehran)
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
Firoozghar Hospital, Tehran University of Medical Scienses
Full name of responsible person
Amir Aziz Seif MD.
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Behafarin St, Karim Khan Ave.
City
Tehran
Postal code
1593748711
Phone
+98 21889379025
Fax
+98 21 8894 2622
Email
amir7044@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Firoozghar Hospital, Tehran University of Medical Scienses