Comparison of the effect of preoperative single dose dexmedetomidine with midazolam on Postoperative shivering after total intravenous anesthesia in ambulatory gynecologic surgeries
The goal of this study is to compare the effect of preoperative administration of a single dose dexmedtomidine with midazolam for prevention of postoperative shivering in patients who received total intravenous anesthesia with remifentanil for outpatient gynecologic surgeries. In this randomized double blind clinical trial, 70 ASA classes I & II patients who were obtained written informed consent candidate for outpatient surgery will be divided to two groups of 35. In all patients, baseline blood pressure, heart rate, Sao2 and body temperature will be noted. Operative room and injected solutions temperature will be the same. All patients will receive anesthesia with loading dose of 2.5 mg/kg Propofol, then infusion of propofol and Remifentanil (0.5 µg/kg/min) will be continued. Group one will be administered Dexmedtomidine 1 µg/kg in 20 ml normal saline over 10 minute and 1 ml normal saline immediately before operation. Group two will receive normal saline in the same volume (as placebo), and 1 mg midazolam. All medications will be prepared in covered syringes and will be injected blindly with an anesthesiologist. The incidence and severity of postoperative shivering will be checked and recorded according to Crossley scores. Shivering scores equal to or higher than 3 will be treated with 25 mg IV meperidine. Data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022410765N13
Registration date:2017-05-18, 1396/02/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-18, 1396/02/28
Registrant information
Name
Sousan Rasooli
Name of organization / entity
Alzahra hospital/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
rasoolis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of preoperative single dose dexmedetomidine with midazolam on Postoperative shivering after total intravenous anesthesia in ambulatory gynecologic surgeries
Public title
Effect of dexmedetomidine on postoperative shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:patients candidate for gynecologic outpatient surgeries;
aged 18 - 45 years; patients will give written informed consent; patients with ASA class I & II
Exclusion criteria: patients with ASA class III or higher; cardiovascular diseases or heart block; bradycardia; hypertension or hypotension; neurological diseases; renal and hepatic diseases; respiratory diseases; diabetics; patients who receive alpha 2 Agonists
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Using a computer-generated randomization table, patients were randomized to one of two groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht Ave, Tabriz University of Medical Scienses,
City
Tabriz
Postal code
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.TBZMED.REC.1395.1149
Health conditions studied
1
Description of health condition studied
Shivering
ICD-10 code
T88.5
ICD-10 code description
Other complications of anaesthesia Hypothermia following anaesthesia
Primary outcomes
1
Description
Incidence of postoperative shivering
Timepoint
Every 15 minutes immidiatly post onset of spinal anesthesia until one hour post anesthesia
Method of measurement
Crossley and Mahjon score
Secondary outcomes
1
Description
Sao2
Timepoint
every 15 minutes
Method of measurement
Palsoximetry
Intervention groups
1
Description
Intervention group: The patients of this group will be receive single dose of dexmedtomidine 1 μg/kg in 20 ml normal saline Iv over 10 minutes and 1 ml placebo immediately before operation
Category
Treatment - Drugs
2
Description
Control group: The patients of this group will be receive 1 mg midazolam and 20 ml normal saline over 10 minutes IV as placebo immediately before operation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Obstetric and Gynecologic Hospital
Full name of responsible person
Sousan Rasouli
Street address
AlZahra Hospital, Sought Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Hasan Soleimanpour
Street address
Recerch Center, Tabriz University of Medical Sciences, Golgasht Ave
City
Tabriz
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 Tabriz 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
Reaserch center, Tabriz University of Medical Scienses
Full name of responsible person
Elahe Madarek
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
madarekE@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reaserch Center, Tabriz University of Medical Scienses
Full name of responsible person
Sousan Rasouli
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
Rasooli_s@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Reaserch center, Tabriz University of Medical Scienses
Full name of responsible person
Sousan Rasouli
Position
professor of Anesthesiology
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
rasooli_s@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)