Protocol summary

Summary
The aim of this study is to evaluate the effect of intravenous magnesium sulfate on hemodynamic effects induced by blowing carbon dioxide in patients undergoing laparoscopic cholecystectomy. It is a randomized double-blind placebo-controlled clinical trial over population of patients who are candidates for laparoscopic gallbladder removal surgery. The main criterias for inclusion are, patients scheduled for laparoscopic cholecystectomy with pneumoperitoneum by CO2, aged 70-20 years, ASA class I- II, and exclusion criteria: chronic use of beta-adrenergic blockers and calcium channel blockers, the willingness of to participate in the Plan and the occurrence of comoplications. The calculated sample size is 60 (2N), patients will go under similar anesthesia. Before induction of anesthesia, in magnesium group, 50 mg/ kg of magnesium sulfate in 100 cc of normal saline and in conyrol group only 100 cc normal saline over 10 minutes will be infused. Mean arterial blood pressure and heart rate, peripheral oxygen saturation, and end expiratory carbon dioxide levels in both groups before and after induction, before pneumoperitoneum, and then every 10 minutes until 60 minutes after pneumoperitoneum will be recorded by automatic Hemodynamic monitoring. After the operation, the pain and the hemodynamic variables, postoperative shivering, nausea and vomiting, the patient's comfort during recovery, would be evaluated. After collecting and recording data, SPSS program will use to analyze and evaluate the differences between the two groups of patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013022311398N2
Registration date: 2013-04-06, 1392/01/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-04-06, 1392/01/17
Registrant information
Name
Mohammad Reza Ghodraty
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
m-ghodrati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Medicine Faculty, Tehran University of Medical Sciences
Expected recruitment start date
2012-09-23, 1391/07/02
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of intravenous magnesium sulfate on hemodynamic changes induced by pneumoperitoneum in patients undergoing laparoscopic cholecystectomy in Firoozgar Hospital during 91-92 years
Public title
The effect of magnesium sulfate on hemodynamic complications of laparoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: consent to participate in research projects - patients scheduled for surgery of laparoscopic cholecystectomy with pneumoperitoneum gas CO2 - Age 70-20 years - physical patients with class ASA I-II . Exclusion criteria: chronic use of drugs beta-adrenergic and calcium-channel blockers - drugs, psychotropic substances, use of lithium, other drugs such as hemodynamic TCA - history of cardiovascular diseases - sensitivity to magnesium sulfate - diseases such as hypertension, diabetes mellitus, renal disease, acute cholecystitis and endocrine or metabolic disease. Cases who develope complications also would be excluded. Also conversion of laparoscopic cholecystectomy to open surgery because of technical problems.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Tehran University Of Medical Sciences Ethic Committee
Street address
Tehran University Of Medical Sciences, Ghods St. Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-09-23, 1391/07/02
Ethics committee reference number
91/d/1361/130

Health conditions studied

1

Description of health condition studied
Laparoscopic cholecystectomy
ICD-10 code
K80.2
ICD-10 code description
Calculus of gallbladder without cholecystitis

Primary outcomes

1

Description
Mean arterial blood pressure
Timepoint
Before and after induction, before pneumoperitoneum, and every 10 minutes after pneumoperitoneum and after surgery
Method of measurement
Will be recorded by Automatic Hemodynamic Monitoring

2

Description
Heart Rate
Timepoint
Before and after induction, before pneumoperitoneum, and every 10 minutes until 60 minutes after pneumoperitoneum and after surgery
Method of measurement
Will be recorded by Automatic Hemodynamic Monitoring

Secondary outcomes

1

Description
Rate of usage of Propofol
Timepoint
One time at the end of surgery
Method of measurement
The mean dose per kilogram of body weight per minute

2

Description
Sedation quality of the patient in recovery
Timepoint
Every 15 minutes
Method of measurement
Clinical evaluation using Ramsay sedation score system

3

Description
Patient's pain acuty during recovery
Timepoint
Every 15 minutes
Method of measurement
According to VAS rating score

4

Description
TNG consumption rate
Timepoint
End of study
Method of measurement
Measuring amount of consumed drug

Intervention groups

1

Description
In the intervention group before induction of anesthesia, infusion of 50 mg/kg of body weigth magnesium sulfate in 100 cc of normal saline over 10 minutes.
Category
Prevention

2

Description
In the plasebo group and for blining of patients and observers before induction of anesthesia 100 ml of normal saline will be infused intravenously in 10 min.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Mohammad Reza Ghodraty MD. Assistant Professor of Anesthesiology
Street address
Anesthesiology Department, Firouzgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Medicine Faculty, Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhoundzadeh Basti MD.
Street address
Faculty of Medicine, Pour Sina Ave, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Medicine Faculty, Tehran 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
Tehran University of Medical Science
Full name of responsible person
Ali Mougouee MD.
Position
Anesthesia Resident
Other areas of specialty/work
Street address
Anesthesiolgy Department, Firouzgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8214 1360
Fax
Email
dr_mougouee@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Firouzgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
m-ghodrati@tums.ac.ir mrghodrati@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Firouzgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
m-ghodrati@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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