Protocol summary

Summary
The aim of this study is adding the magnesium sulfate to pain reduction . We assessed the efficacy with VAS. After the approval of ethical committee of University, we obtained a written consent from the patients in a day before surgery. We trained the patients about how to use the visual analogue scale (VAS) . We used the general anesthesia in all patients. We used the same premedication (midazolam 2-3 mg and 1-2 micro/kg Fentanyl ) and induction ( 1/5-2 mg/kg propofol and ./5mg/kg atracurium ) . After that we use the propofol infusion . After the patient interance to recovery room , The patients were randomly assigned to two groups: case group ( magnesium sulfate) and control group . We used the PCIA for all patients . In group 1 ( 40 patients) we infused 30mg/kg sulfate magnesium in 250 cc sodium chloride (over 10 minute) and then 10 mg/kg for 48 hours. We add the above drugs to fentanyl pump . In control group (40 patients) we infused the 250cc sodium chroride over 10 minutes and then the equal volume of magnesium sulfate were infused. We evaluated the heart rate (HR), mean arterial pressure (MAP) and arterial oxygen saturation during the first 6 hours every 2 hours, then 6, 12 , 18 , 24 and 48 after that . Inclusion criteria : patients with the age group of 20 to 50 years؛ patients with ASA I, II , orthopedic surgery will be done under the same procedure with General anesthesia and the surgical team are the same . Exclusion criteria : Patients who have major disease of liver؛ kidney؛ cardiovascular؛ asthma and COPD ؛ patients were treated with calcium channel blocker. In patient with VAS > 4 and continuous and persistent pain, additional 50 micro fentanyl are to be considered. VAS and drug prescribed will be recorded at this time. The patient's pain have been assessed with visual analogue scale (VAS) and will be recorded at 1 , 6 , 12 , 18 , 24 and 48 hours. The patient,s sedation have been assessed with ramsay sedation score in 1 , 6 , 12 , 18 , 24 and 48 hours. We will have evaluated the magnesium serum level at 12 and 24 hours. Anesthesiologist who is not aware of the patient group is responsible for the assessment of the amount of sedation, pain , fentanyl consumption and hemodynamic variables. Side effects such as hypotension (SBP < 100 mmhg) , heart rate <60 b/min, nausea and vomiting have been recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201411017984N21
Registration date: 2015-01-04, 1393/10/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-01-04, 1393/10/14
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
farnadimani@yahoo.com
Recruitment status
Recruitment complete
Funding source
V ice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of evaluation of pain control in orthopaedic surgery after adding magnesium sulfate to fentanyl infusion
Public title
Clinical trial of evaluation of pain control in orthopaedic surgery after adding magnesium sulfate to fentanyl infusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patients with the age group of 20 to 50 years؛ patients with ASA I, II , orthopedic surgery will be done under the same procedure with General anesthesia and the surgical team are the same . Exclusion criteria : Patients who have major disease of liver؛ kidney؛ cardiovascular؛ asthma and COPD ؛ patients were treated with calcium channel blocker.
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences.
Street address
Hemat "Exp". Way, Vice chancellor for research, Iran University of Medical Sciences, beside Milad Tower, Tehran
City
Tehran
Postal code
1443763187
Approval date
2014-10-19, 1393/07/27
Ethics committee reference number
105412-20410-30-01-92

Health conditions studied

1

Description of health condition studied
Clinical trial of evaluation of pain control in orthopaedic surgery after adding magnesium sulfate to fentanyl infusion
ICD-10 code
XIII
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
Pain
Timepoint
1 , 6 , 12 , 18 , 24 , 48
Method of measurement
Visual analogue scale (VAS)

Secondary outcomes

1

Description
Sedation
Timepoint
First and 1,6,12,18,24,48 hours later
Method of measurement
Ramsay score

Intervention groups

1

Description
Group 1 (magnesium sulfate ) 40 patients, we infused fentanyl plus magnesium sulfate in ordered below: 30mg/kg sulfate magnesium in 250 cc sodium chloride (over 10 minute) and then 10 mg/kg for 48 hours.
Category
Treatment - Drugs

2

Description
In control group (40 patients) we infused the 250cc sodium chroride over 10 minutes and then the equal volume of magnesium sulfate were infused.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Karim Hematy
Street address
Niayesh "St", Sattarkahn "St, 4th Floor, Department of pain, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research , Iran University of Medical Sciences
Full name of responsible person
Ali Javad Mousavi
Street address
Hemat "Exp". Way, Vice chancellor for research, Iran University of Medical Sciences, beside Milad Tower, Tehran
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 , Iran 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
Iran University of Medical Sciences
Full name of responsible person
Karim Hemati
Position
Second administrator- Associate professor of anesthesia , pain fellow ship
Other areas of specialty/work
Street address
Niayesh "St", Sattarkahn "St, 4th Floor, Department of pain, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.
City
Tehran
Postal code
364- 14455
Phone
+98 216653921
Fax
Email
khematy@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Associate professor - pain fellow ship
Other areas of specialty/work
Street address
Niayesh "St", Sattarkahn "St, 4th Floor, Department of pain, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.
City
Tehran
Postal code
364-14455
Phone
+98 21 6650 9059
Fax
Email
farimani@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Karim Hemati
Position
Second administrator- Associate professor of anesthesia , pain fellow ship
Other areas of specialty/work
Street address
Niayesh "St", Sattarkahn "St, 4th Floor, Department of pain, Hazrat-E-Rasoul Hospital, Iran University of Medical Sciences, Tehran, Iran.
City
Tehran
Postal code
14455- 364
Phone
+98 21 6650 9059
Fax
Email
khematy@gmail.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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