Comparison of Postoperative Shivering after Remifentanil-Propofol versus fentanyl-propofol Intravenous Anesthesia in patients undergoing ambulatory Gynecologic Procedures
Postanesthesia shivering (PAS) is a frequent side effect of general anesthesia and one of the leading causes of patients discomfort after recovery from anesthesia especially in ambulatory setting. The aim of this study was to evaluate the effects of remifentanil versus fentanyl on postoperative shivering and its relationship with intraoperarive hypothermia. In this double blind randomized clinical trial, after receiving an written informed consents, 110 patients with American Society of Anesthesiology (ASA) physical status I or II, scheduled for ambulatory gynecologic procedures, will randomly assign to one of two groups of 55. Basic vital signs (arterial blood pressure, heart rate and Sao2) and core body tympanic membrane temperature will be measured and recorded. Room temperature will be adjusted at 22-24 ºC. Fluids temperature will be equal to the operating rooms temperatures. General anesthesia will induce with midazolam 0/05 mg/kg IV, propofol 2-2.5 mg/kg IV and follow by infusion of propofol 5-10µg/kg/h in both groups. In remifentanil group remifentanil 1 µg/kg IV will be administered for induction and infused in the range of 0.1-0.25 µg/kg/h for maintenance of anesthesia. In fentanyl group, fentanyl 1 µg/kg IV will be administered for induction and repeated as needed for maintenance of anesthesia. Patients' vital signs and core body temperatures will be recorded throughout surgery at certain intervals. After surgery, patients will be evaluated in recovery room for hemodynamic variables and severity of shivering( according to Wrench five-point rating score) as well as Pain, nausea-vomiting and agitation every 15 minutes until discharge from recovery. Analysis will be performed using SPSS 16.0 program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015043011700N7
Registration date:2015-08-20, 1394/05/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-20, 1394/05/29
Registrant information
Name
Farnaz Moslemi Tabrizi
Name of organization / entity
Alzahra hospital, Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
moslemif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Tabriz Azad University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Postoperative Shivering after Remifentanil-Propofol versus fentanyl-propofol Intravenous Anesthesia in patients undergoing ambulatory Gynecologic Procedures
Public title
Evasluation of the effect of remifentanil on postoperative shivering after ambulatory gynecologic procedures
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: patients with American Society of Anesthesiology (ASA) physical status I or II; patients scheduled for ambulatory gynecologic procedures
Exclusion criteria: patients with ASA class III or higher; patients with cardiopulmonary diseases; Preoperative fever; use of any anti pyretic or anti-inflammatory medication; any surgery time longer than 2 hours
Age
From 17 years old to 52 years old
Gender
Female
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz Islamic Azad University ,faculty of Medicine
Street address
Faculty of Medicine,Manzarieh ave,Tabriz
City
tabriz
Postal code
Approval date
2014-12-20, 1393/09/29
Ethics committee reference number
8705385029423
Health conditions studied
1
Description of health condition studied
Postoperative shivering
ICD-10 code
R00-R99
ICD-10 code description
R68.0 Hypothermia, not associated with low environmental temperature ,hypothermia (due to)(of):anaesthesia (T88.5)
Primary outcomes
1
Description
Severity of postoperative shivering
Timepoint
in recovery every 15 minutes until discharge from recovery
Method of measurement
Crossly and Mahjon five-point scoring system
Secondary outcomes
1
Description
pain
Timepoint
in recovery room every 15 minutes until discharge from recovery
Method of measurement
visual analog score
Intervention groups
1
Description
Interventional group: In remifentanil group, general anesthesia will induce with midazolam0.05 mg/kg IV, propofol 2-2.5 mg/kg IV and follow by infusion of propofol 5-10µg/kg/h.Then,remifentanil 1 µg/kg IV was administered for induction and infused in the range of 0.1-0.25 µg/kg/h for maintenance of anesthesia according to the patient's heart rate and blood pressures variations.
.
Category
Prevention
2
Description
Control group: In group fentanyl (group F)general anesthesia will induce with midazolam0.05 mg/kg IV, propofol 2-2.5 mg/kg IV and follow by infusion of propofol 5-10µg/kg/h .Then, fentanyl 1 µg/kg IV was administered for induction and repeated as needed for maintenance of anesthesia to keep the depth of anesthesia according to the patient's heart rate and blood pressures variations.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
AlzahraTeaching Hospital ,Tabriz University of Medical Sciences
Full name of responsible person
Dr Farnaz Moslemi
Street address
Alzahra Teaching Hospital,south Artesh ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz azad Islamic University ,faculty of Medicine
Full name of responsible person
dr Farnaz Moslemi
Street address
Tabriz, Artesh Ave, Alzahra Hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz azad Islamic University ,faculty of Medicine
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
Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Moslemi
Position
Associate Professor, Specialist in Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
+98 41 3554 4669
Email
moslemifa@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reaserch Center , Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Moslemi
Position
Associate Professor, Anesthesiologist
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
Moslemifa@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Moslemi
Position
Associate Professor, Anesthesiologist
Other areas of specialty/work
Street address
Alzahra Hospital, Artesh Ave, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
Moslemifa@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)