Protocol summary

Study aim
Determining the effectiveness and speed of shivering treatment after general anesthesia with pethidine and doxapram.
Design
This study is a double-blind, randomized, phase 3 clinical trial with control group, with parallel groups and 56 patients and uses block randomization method.
Settings and conduct
Patients seeking orthopedic or urological surgery undergo standard anesthesia. When patients regain consciousness and have chills, all non-pharmacological procedures such as warming or covering the patient with a blanket are performed. If there is no response to treatment, patients are divided into two groups. In the first group, selected patients are injected with pethidine based on their weight, and in the second group, patients are injected with doxapram based on their weight, and the findings are recorded and analyzed based on the objectives. This study is performed in Firoozgar Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with ASA I, II anesthesia level, Patients aged 20 to 60 years undergoing orthopedic surgery and nephrology, Surgery less than 4 hours Exclusion criteria: History of lung disease, Drug allergy to pethidine or doxapram.
Intervention groups
Group 1: Patients who have not responded to non-pharmacological treatment of shivering after surgery and will be injected with pethidine based on their weight. Group 2: Patients who have not responded to non-pharmacological treatment of shivering after surgery and will be injected with doxapram based on their weight.
Main outcome variables
Shivering after surgery, Hypoxia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140109016151N9
Registration date: 2021-03-12, 1399/12/22
Registration timing: registered_while_recruiting

Last update: 2021-03-12, 1399/12/22
Update count: 0
Registration date
2021-03-12, 1399/12/22
Registrant information
Name
Alireza Pournajafian
Name of organization / entity
Iran University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
a-pournajafian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness and speed of shivering treatment after general anesthesia with pethidine and doxapram in patients undergoing orthopedic surgery and urological surgery referred to Firoozgar Hospital in Tehran.
Public title
Comparison of effectiveness and speed of shivering treatment after general anesthesia with pethidine and doxapram.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ASA I, II anesthesia level Patients aged 20 to 60 years undergoing orthopedic and urological surgery Surgery less than 4 hours
Exclusion criteria:
History of lung disease Drug allergy to pethidine or doxapram
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we use the block randomization method so that after selecting patients according to the inclusion and exclusion criteria by selecting numbers from the table of random numbers and adapting to the blocks, patients are divided into study groups.To randomize the two treatment methods, we create 4 blocks in six different states, then select a number using the table of numbers, and determine the study groups by matching the numbers with the blocks. For example, if the first digit of our number is 1 to 6, select a block and the division is done, but if, for example, our number is 94071, the digit 9 is not valid and we select the next digit. Here, based on the block, we divide 4 people into groups. 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, people who are responsible for patient care and analysis of statistical data do not know about the treatment process and study groups, and information is provided to them in groups A and B.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
8874113911
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.IUMS.FMD.REC.1399.321

Health conditions studied

1

Description of health condition studied
orthopedic surgery
ICD-10 code
M96.62
ICD-10 code description
Fracture of humerus following insertion of orthopedic implant, joint prosthesis, or bone plate

Primary outcomes

1

Description
Shivering after surgery
Timepoint
After surgery
Method of measurement
observation

Secondary outcomes

1

Description
Hypoxia
Timepoint
After surgery
Method of measurement
Pulse oximeter

Intervention groups

1

Description
Intervention group: Patients who have not responded to non-pharmacological treatment of chills after surgery and are injected with pethidine made by Caspian Pharmaceutical Company (50 mg ampoule per cc) .To treat chills, 25 mg of pethidine is injected in a single dose.
Category
Treatment - Drugs

2

Description
Intervention group: Patients who did not respond to non-pharmacological treatment of shivering after surgery were injected with doxapram, a Caspian drug company based on weight. According to the treatment protocol, the dose of doxapram is 0.7mg / kg.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Alireza Pournajafian
Street address
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
a-pournajafian@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motavalian
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8670 5503
Email
motevalian.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Alireza Pournajafian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
a-pournajafian@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Pournajafian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
a-pournajafian@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Pournajafian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesia Department, Firouzgar Hospital ,Beh-afarin street
City
Tehran
Province
Tehran
Postal code
8874113911
Phone
+98 21 8894 6762
Email
a-pournajafian@tums.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
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