Comparison of the effect of intravenous bolus Dexmedetomidine and Mepridine on the treatment of shivering following general anesthesia
Design
A total of 100 patients will be selected according to studies and statistical calculations with inclusion criteria after surgery and discharged from anesthesia divided into two groups of intervention and control. The intervention group will receive Dexmedomedine and the control group will receive Pethidine. The study is a randomized, double-blind, placebo-controlled clinical trial.
Settings and conduct
The study will be conducted in the recovery ward of Tabriz Imam Reza Hospital. The control group will receive Pethidine (Auxir-Iran Co.) 10 mg and the intervention group will use Dexmedomidine (Imagen-Iran) 1 mg / kg body weight and then hemodynamic variables of patients including blood pressure and the patient's heart rate, blood oxygen saturation and axillary temperature will be recorded every 5 minutes by the anesthesiologist. Also, the severity of shivering in patients, the rate of response to treatment within 15 minutes of treatment initiation, and the duration of shivering will be documented in both groups. In this study, patients and anesthesiologists are blinded to the study.
Participants/Inclusion and exclusion criteria
Inclusion: Patients with ASA grade one or two in the age group of 18 to 65 years who have had grade 3 or 4 postoperative shivering؛ Exclusion: Patients under 18 or over 65 years of age, Previous sensitivity to Pethidine and Dexmedetomidine and patient's low blood pressure
Intervention groups
Dexmedomidine will be used in the intervention group and Pethidine will be used in the control group.
Main outcome variables
Primary outcome: Time required for shivering and Secondary outcome: Minimum dose of drug needed to stop shivering and stabilize hemodynamic effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150125020795N4
Registration date:2019-10-04, 1398/07/12
Registration timing:registered_while_recruiting
Last update:2019-10-04, 1398/07/12
Update count:0
Registration date
2019-10-04, 1398/07/12
Registrant information
Name
Samad Golzari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3556 6183
Email address
golzaris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-01-19, 1398/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of intravenous bolus Dexmedetomidine and mepridine on the treatment of shivering following general anesthesia
Public title
The efficacy of intravenous bolus Dexmedetomidine and mepridine on the treatment of shivering following general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA grade one or two
Age range of 18 to 65 years
After surgery, the patient has grade 3 or 4 shivering anesthesia.
Exclusion criteria:
Patients under 18 or over 65 years
Previous sensitivity to pethidine or dexmedetomidine
Patient's low blood pressure
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients wishing to participate in the study who meet the inclusion criteria will be selected as available sampling and then randomly assigned to two control and intervention groups using Randlist software.
Blinding (investigator's opinion)
Double blinded
Blinding description
An anesthesiologist who evaluates patients' response to the prescribed drug and also patients who are unaware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-07-03, 1398/04/12
Ethics committee reference number
IR.TBZMED.REC.1398.400
Health conditions studied
1
Description of health condition studied
Shivering following general anesthesia
ICD-10 code
T88.5
ICD-10 code description
Other complications of anesthesia
Primary outcomes
1
Description
Stop shivering
Timepoint
After surgery and the patient is discharged from anesthesia, shivering will be recorded within 15 minutes of treatment initiation and shivering time.
Method of measurement
Observe and record the severity (shivering grade) and duration of shivering
Secondary outcomes
1
Description
Hemodynamic effects
Timepoint
After surgery and the patient is discharged from anesthesia, Patients with Grade 3 and 4 shivering, blood pressure and heart rate, oxygen saturation and axillary temperature will be measured every 5 minutes.
Method of measurement
Blood pressure and heart rate measurement using a monitoring and oxygen saturation percentage using an pulseoximeter and axillary temperature using a digital thermometer
Intervention groups
1
Description
Intervention group: In the intervention group, dexmedomidine (Imagen-Iran) will be used 1 µg / kg body weight.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive 10 mg of pethidine (Exir - Iran).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Samad Eslam Jamal Golzari
Street address
Department of Anesthesiology., Faculty of Medical Sciences., Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Street address
Department of Anesthesiology., Faculty of Medicine., Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology., Faculty of Medicine., Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology., Faculty of Medicine., Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology., Faculty of Medicine., Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Email
golzaris@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available