Objectives: to investigate the effect of intraoperative intravenous infusion of Mg sulfate during Laminectomy on post-operative analgesia Study design: randomized double-blind controlled clinical trial. Inclusion criteria: aged 18-60 with ASA class I-II who were candidate for elective laminectomy.
Exclusion criteria: major dysfunctions of liver, kidney or cardiovascular system especially atrioventricular block, experience of previous treatment with calcium channel blockers and drug abuse. The patients with coagulation disorders and emergent surgeries were also excluded from the study. Intervention: The 40 adult patients were randomly assigned into two groups of case and control group, they were similarly anesthetized. In the case group, after the induction of anesthesia, a loading dose of magnesium sulfate (30 mg/kg) was administered within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/h up to the end of the surgery; while, in the control group patients received normal saline. After the surgery, all patients received a patient-controlled intravenous analgesia (PCA) pump containing morphine. The first time of using PCA , the amount of consumed morphine during the first 24 hours, and pain score were recorded at 6,12,18 and 24 hours in the post-operative period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012019470N12
Registration date:2015-04-01, 1394/01/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-01, 1394/01/12
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
2013-08-23, 1392/06/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intraoperative intravenous infusion of Mg sulfate during Laminectomy on post-operative analgesia
Public title
The effect of intraoperative intravenous infusion of Mg sulfate during Laminectomy on post-operative analgesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 18-60 of age, ASA class I-II who were candidate for elective laminectomy.
Exclusion criteria: major dysfunctions of liver, kidney or cardiovascular system especially atrioventricular block, experience of previous treatment with calcium channel blockers and drug abuse, patients with coagulation disorders and emergent surgeries.
Age
From 1 month old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 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-90-2703
Health conditions studied
1
Description of health condition studied
Laminectomy
ICD-10 code
M51.1+
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy (G55.1*)
Primary outcomes
1
Description
the effect of intraoperative intravenous infusion of Mg sulfate during Laminectomy on post-operative analgesia
Timepoint
pain score were recorded at 6,12,18 and 24 hours in the post-operative period.
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
In the case group, after the induction of anesthesia, a loading dose of magnesium sulfate (30 mg/kg) was administered within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/h up to the end of the surgery.
Category
Treatment - Drugs
2
Description
In the control group patients received normal saline after the surgery.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Ashkan Rahimi
Street address
Zand Street, Namazee Hospital
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 Seed 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
Ashkan Rahimi
Position
Anesthesia Resident/ Physician
Other areas of specialty/work
Street address
Department of anesthesia, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
ashkan_Rahimi1981@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sina Ghafaripour
Position
Fellowship in Anesthesia for Abdominal Organ Transplantation
Other areas of specialty/work
Street address
Anesthesiology Office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
sighafari@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)