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The Effect of Magnesium Sulfate on Reducing Intraocular Pressure during Laparoscopic Cholecystectomy

Protocol summary

Summary
Objectives: The aim of this study was to investigate the prophylactic effect of magnesium sulfate on the intraocular pressure in patients undergoing laparoscopic cholecystectomy. This study is a randomized, double-blind clinical trial. Inclusion criteria: age of eighteen years and above, ASA I and II, weighting between 50 to 80 kg, patients who had been scheduled for laparoscopic cholecystectomy. Exclusion criteria: arrhythmia, heart diseases, musculoskeletal diseases like myasthenia Grove, kidney failure, acute or chronic eye disease, history of using any drugs that affects intraocular pressure. Patients were randomly divided into two groups of intervention group who received 30 mg/kg magnesium sulfate and patients in control group received 20 cc, normal saline. Sample Size: 40 patients found eligible based on the inclusion criteria. Interventions: The magnesium sulfate was solved in 100cc normal saline and infused within 20 minutes in the treatment group, and 100 cc normal saline was infused to patients in control group before the operation. The possibility of Magnesium toxicity was quite low with this dose but neurological examinations were done for every patient. Mean arterial blood pressure, heart rate, intraocular pressure, (paw) peak and plate airway pressure, ETCO2 were measured, continuously during the operation. Tetracaine eye drop was used before measuring intraocular pressure via Tonopen. CO2 insufflation was done in supine position and peritoneal gas pressure was maintained at 12 mmHg during the operation. Primary and secondary outcome measures were to investigate the prophylactic effect of magnesium sulfate on the intraocular pressure during laryngoscopy, intubation and CO2 insufflation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014122219470N6
Registration date: 2015-01-09, 1393/10/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-09, 1393/10/19
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2014-02-01, 1392/11/12
Expected recruitment end date
2014-10-01, 1393/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Magnesium Sulfate on Reducing Intraocular Pressure during Laparoscopic Cholecystectomy
Public title
Prophylactic Effect of Magnesium Sulfate on Intraocular Pressure Rising during Laparoscopic Cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Adult patients, ASA I and II, weighting between 50 to 80 kg, Patients who had been Scheduled for Laparoscopic Cholecystectomy. Exclusion criteria: Arrhythmia in ECG, Cardiac Disease, Musculoskeletal Diseases like Myasthenia Grove,Renal Failure, Acute or Chronic Eye Disease, History of Using any Drugs that Affects Intraocular Pressure.
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Ethic Committee of Shiraz University Of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
CP-P-9336-3696

Health conditions studied

1

Description of health condition studied
Increased Intraocular Pressure
ICD-10 code
H40.0
ICD-10 code description
Ocular Hypertension

Primary outcomes

1

Description
Effect of Magnesium Sulfate on the Intraocular Pressure
Timepoint
During Larangoscopy and Intubation
Method of measurement
Tonopen

Secondary outcomes

1

Description
Effect of Magnesium Sulfate on the Intraocular Pressure
Timepoint
During CO2 Insufflation
Method of measurement
Tonopen

Intervention groups

1

Description
Intervention Group:The Magnesium Sulfate was Solved in 100cc Normal Saline and Infused within 20 Minutes in the Treatment Group
Category
Treatment - Drugs

2

Description
Control group:100 cc Normal Saline was Infused to Patients in the Control Group Before the Operation
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazee Hospital
Full name of responsible person
Abdolsamad Saleh
Street address
Anesthesiology Office, Namazi Hospital, Zand Street
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyd Basir Hashemi
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, 7th floor-Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Abdolsamad Saleh
Position
Physician, Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
saleha@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Reza Joybar
Position
Anesthesilogist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
joybarr@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
English Consultant,Anesthesiology Research Center Staff
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihif@sums.ac.com; masihifarzaneh@yahoo.com
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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