Comparison of epidural administration of magnesium sulfate and analgesic in postoperative shivering through Trans urethral prostate resection surgery (TURP)
TURP is a surgery to remove the prostate through urethra with Resectoscope. The effect of this study is to prevent and control the chills and shivering after epidural injection of magnesium sulfate . 60 patients scheduled for elective surgery for implementation of the TURP by ASA I, II, age 65 to 40 years will be studied.
Exclusion criteria: hypothermia(T less than 36C), or fever (T more than 38C), finding in favor of Hypo or hyperthyroidism, Parkinson's disease, Raynaud syndrome, myocardial ischemia, cerebrovascular, the need for blood transfusions during surgery, requiring dilator are excluded from the study.
Patients randomized to one of two groups: Magnesium sulfate group M) (analgesic group (P).
Up to 50 mg of magnesium sulfate 20%,in magnesium sulfate group ( normal saline in combination with maximum 1CC) and 25 mg of analgesic (normal saline in combination with maximum (1CC in second group is injected through the epidural space.
Pink Prink Test Method for assessment of sensory block is evaluated and the motor block Bromage Scale method was Checked. the number and intensity of shivering chills for 2 groups during operation and in recovery will be registered
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051111766N3
Registration date:2015-07-24, 1394/05/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-07-24, 1394/05/02
Registrant information
Name
Hossein Khoshrang
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 0028
Email address
khoshrang@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University Of Medical Sciences
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2015-12-31, 1394/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of epidural administration of magnesium sulfate and analgesic in postoperative shivering through Trans urethral prostate resection surgery (TURP)
Public title
The effect of ٍEpidural prescription of magnesium sulfate and Pethedine on shivering through the Trans urethral prostate resection surgery (TURP)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: patients undergoing TURP elective surgery with ASA I, II, age 65 to 40 years
Exclusion criteria: hypothermia (T less than 36C), or fever ( (T more than 38C);Blood transfusions; Requiring dilator
Age
From 40 years old to 65 years old
Gender
Male
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti Freeway
City
Rasht
Postal code
4193833697
Approval date
2015-04-27, 1394/02/07
Ethics committee reference number
gums.rec.1394.4
Health conditions studied
1
Description of health condition studied
Prostate Hyperplasia
ICD-10 code
N40
ICD-10 code description
Prostate Hyperplasia
Primary outcomes
1
Description
Chills
Timepoint
End of surgery and recovery room
Method of measurement
Chills or not.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Group of magnesium sulfate 50 mg of magnesium sulfate 20% (normal saline in combination with maximum 1CC)
Category
Treatment - Drugs
2
Description
Intervention 2: Pethedine 25 mg (normal saline 1 CC maximum (
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Hossein Khoshrang
Street address
Fifteenth Khordad Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshti Freeway
City
Rasht
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 of Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Hossein Khoshrang
Position
Anesthesiologist
Other areas of specialty/work
Street address
Razi Hospital
City
Rasht
Postal code
4193955599
Phone
+1 333368534
Fax
+98 13 3336 8651
Email
www.arc.gums.ac.ir
Web page address
arcguilan1392@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Hossein Khoshrang
Position
Anesthesiologist
Other areas of specialty/work
Street address
Razi Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 3336 8534
Fax
+98 13 3336 8651
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedyeh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3336 8534
Fax
+98 13 3336 8651
Email
nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)