The effect of IV infusion of mgso4 was evaluated on less need to opium and prolongation of block duration ln patients under lower extremity surgeries with spinal anesthesia.
Study was carried out in a double blind manner, one centric clinical trial and by simple randomized method (closed packet and the selection of painted cards) on sixty patients with 45_75 year’s old, candidate for elective surgery of lower extremity fractures with spinal anesthesia in Rajai hospital of Qazvin.
All patients were in American Society of Anesthesia ( ASA) class І and II and drug abusers or magnesium supplement receivers were excluded. Magnesium group (M) after 15 minutes of spinal anesthesia received 50mg/kg mgso4 20% in 250 cc NACL 0.9% in 20 minutes and control group(C) received only 250 cc NACL during the same time.
At the end of operation a patient control analgesia device (pca) was used for two groups, contain morphine 20m, ondancetron 8mg, apotel 2 gr and dexamethasone 8 mg (in the first 24 hours) and. dosage of all drugs was change to one half for the second 24h. The amount of opium consumption, pain and duration of block were the same as primary variable outcome and the general pleasure and quality of sleep were as the second variable outcome, in the time courses of 4, 6, 12, 24 and 48 after operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022825676N3
Registration date:2016-05-07, 1395/02/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-07, 1395/02/18
Registrant information
Name
Hamid Kayalha
Name of organization / entity
Qazvin University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 1007
Email address
hkayalha@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research Qazvin University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of magnesium sulfate on reduction of need to opium, prolongation of block duration and pain after lower extremity fractures surgery operation
Public title
Effect of magnesium sulfate on reduction of need to opium after lower extremity fractures surgery operation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 45_75 years old; ASA 1 & 2; undergoing elective surgery of lower extremity fractures ; spinal anesthesia; pleasure in entrance to study.
Exclusion criteria: diabetes; hypertension; myopathy; opium or alcohol addiction; Advanced heart disease and heart block inside; kidney & liver disorders; magnesium supplement & calcium channel blocker receivers; pregnant patients & neurologic disorders.
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
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
Random sampling is based on selection of colorful cards.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Medical Sciences
Street address
Qazvin, Shahid Bahonar Blvd
City
Qazvin
Postal code
3419759811
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
IR.QUMS.REC.1394.232
Health conditions studied
1
Description of health condition studied
lower limb fracture
ICD-10 code
T12
ICD-10 code description
Fracture of lower limb, level unspecified
Primary outcomes
1
Description
Pain
Timepoint
Immediately after operation and 4, 8, 12, 24 & 48 Hours after
Method of measurement
Score of pain in Visual analog scale (VAS)
2
Description
Amount of analgesic consumption
Timepoint
24 & 48 hours after operation
Method of measurement
Patient control analgesia poump
3
Description
Duration of spinal block
Timepoint
Since start of spinal anesthesia till return of sensory motor block after operation
Method of measurement
Objective
Secondary outcomes
1
Description
Quality of sleep
Timepoint
The first night after operation
Method of measurement
Score of sleep in Visual analog scale (VAS)
2
Description
Patients satisfaction of pain control
Timepoint
Immediately after operation and 4, 8, 12, 24 & 48 Hours after
Method of measurement
Score of satisfaction based on Visual analog scale (VAS)
Intervention groups
1
Description
In magnesium group (M) after spinal anesthesia, 15minute later 50mg/kg from 20% magnesium solution in 250 cc Normal saline in 20 minutes administered.
Category
Treatment - Drugs
2
Description
Control group (c), after spinal anesthesia 15 minuits later from block received only 250cc normal saline.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajee Hospital
Full name of responsible person
Parastu Izadpanahi
Street address
Rajee Hospital, Padegan Avenu, Qzvin.
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Qazvin University of Medical Sciences
Full name of responsible person
Dr. Taghi Naserpour
Street address
Shahid Bahonar Blvd, Qazvin
City
Qazvin
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 Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Parastu Izadpanahi
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
Rajee Hospital, Padegan Avenu, Qzvin
City
Qazvin
Postal code
Phone
+98 28 3376 0620
Fax
Email
vcrc92@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University Of Medical Sciences
Full name of responsible person
Dr. Hamid Kayalha
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Medical School, Qazvin University Of Medical Sciences, Shahid Bahonar Blvd
City
Qazvin
Postal code
Phone
+98 28 3333 6001
Fax
Email
h_kayalha@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Parastu Izadpanahi
Position
Assistant of Anesthesiology
Other areas of specialty/work
Street address
City
Qazvin
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)