This study is going to evaluate post-operative hyperalgesia due to infusion of high dose of remifentanil (for inducing hypotension) during rhinoplasy and prophylactic effect of magnesium sulfate on this side effect of remifentanil. This is a double blind clinical trial on 105 candidates for Rhinoplasy in Alzahra Medical Center. Inclusion criteria are: 15 to 65 years old and no contraindication for magnesium sulfate, remifentanil or nitroglycerin.
Patients select by simple sampling and after inducing of anesthesia allocate in 3 groups (35 patients in each group). In first group 30 mg/kg magnesium sulfate inject in 10 minutes then continuous infusion of 0.05 to 0.2 µg/kg remifentanil begin. In second group normal saline (placebo) in a similar syringe inject in 10 minutes then continuous infusion of 0.05 to 0.2 µg/kg remifentanil begin. In third group normal saline (placebo) in a similar syringe inject in 10 minutes then continuous infusion of 1 to 20 µg/kg nitroglycerin begin. Remifentanil and nitroglycerin inject by infusion pump and speed of infusion adjust to keep blood pressure 30% lower than base (preoperative blood pressure). For double blinding all drugs prepare and take randomization code by a coworker other than main researchers. Vital signs and total amount of drugs record in three groups. Pain measurement takes before discharge from recovery, 6 and 24 hours after surgery by Visual Analog Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071216415N3
Registration date:2014-08-02, 1393/05/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-02, 1393/05/11
Registrant information
Name
Mohammad Golparvar
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3220 1750
Email address
golparvar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-04-04, 1393/01/15
Expected recruitment end date
2014-10-07, 1393/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of evaluating effect of remifentanil in post-operative hyperalgesia and prophylactic effect of magnesium sulfate
Public title
Evaluating effect of remifentanil in post-operative hyperalgesia and prophylactic effect of magnesium sulfate on it
Purpose
Prevention
Inclusion/Exclusion criteria
Age 15 to 65 years old; ASA 1 and 2; without history of usage of neuro-psychological drugs; without history of usage of NSAIDs; no contraindication for TNG; no contraindication for magnesium sulfate; no contraindication for remifentanil
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
105
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 vice research of medical school of Isfahan University of Medical Sciences
Street address
Vice research of medical school; Isfahan University of Medical Sciences; Hezarjarib boulevard; Isfahan; Iran
City
Isfahan
Postal code
Approval date
2014-02-19, 1392/11/30
Ethics committee reference number
16259
Health conditions studied
1
Description of health condition studied
Hypotension due to drugs
ICD-10 code
I95.2; T65
ICD-10 code description
Hypotension due to drugs; Nitroglycerin and other nitric acids and esters
Primary outcomes
1
Description
Severity of pain
Timepoint
Before discharge from recovery; 6 hours after surgery; 24 hours after surgery
Method of measurement
By VAS
Secondary outcomes
empty
Intervention groups
1
Description
Prescription of magnesium sulfate 30 mg/kg and continuous infusion of remifentanil 0.05 to 0.2 microgram/kg/min
Category
Treatment - Drugs
2
Description
Prescription of placebo (normal saline) and continuous infusion of remifentanil 0.05 to 0.2 microgram/kg/min
Category
Treatment - Drugs
3
Description
Prescription of placebo (normal saline) and continuous infusion of nitroglycerin 1 to 20 microgram/kg/min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Medical Center
Full name of responsible person
Golparvar M. MD
Street address
Department of anesthesia, Alzahra Medical Center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and technology of Isfahan University of Medical Sciences
Full name of responsible person
Dr Alimohammad Sabzeghabaei
Street address
Research manager office, Isfahan University of Medical Sciences, Hezarjarib Boulevard, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and technology of Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar M MD
Position
Associate professor in Medical School of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Department of anesthesia, Alzahra Medical Center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3624 9031
Fax
Email
golparvar@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar Mohammad MD
Position
Associate Professor in Medical School of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Department of anesthesia, Alzahra Medical Center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3624 9031
Fax
Email
golparvar@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Golparvar Mohammad MD
Position
Associate Professor in Medical School of Isfahan University of Medical Sciences
Other areas of specialty/work
Street address
Department of anesthesia, Alzahra Medical Center, Sofeh boulevard, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3624 9031
Fax
Email
golparvar@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)