Protocol summary
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Study aim
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The effect of Atracurium and Cisatracurium on post-operative shivering in orthopedic surgery of the lower limbs
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Design
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The study is done as a double blind randomized clinical trial on patients who candidate for orthopedic surgery. Patients randomly (using computer software) are divided into two groups of 30 cases (A and B).
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Settings and conduct
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The study is done as a double blind randomized clinical trial on patients who are candidate for orthopedic surgery at Shahid Rajaeei Hospital in Qazvin. Patient and investigator are not informed of the treatment allocation. Treatment is written on a piece of paper and puts into one envelope and is encrypted confidentially by supervisor.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients who completed informed consent form; Patients aged 20 to 60 years.
Non-inclusion criteria: Underlying illnesses; Allergy to anesthetic drugs; Abnormal responses to non-depolarized musculoskeletal muscle relaxants.
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Intervention groups
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Group A: administration 0.5 mg / kg Atracurium
Group B: administration 0.15-0.2 mg / kg Cisatracurium
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Main outcome variables
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Postoperative Shivering
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170408033291N2
Registration date:
2019-03-31, 1398/01/11
Registration timing:
prospective
Last update:
2019-04-03, 1398/01/14
Update count:
1
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Registration date
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2019-03-31, 1398/01/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-04-20, 1398/01/31
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Expected recruitment end date
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2020-02-19, 1398/11/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Atracurium and Cisatracurium on post-operative shivering in orthopedic surgery of the lower limbs
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Public title
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The effect of Atracurium and Cisatracurium on post-operative shivering
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients who completed informed consent form
Being at the age of 20 to 60 years old
Patients in class I and II based on the American Society of Anesthesiologists (ASA) classification
Exclusion criteria:
Underlying illnesses
Allergy to anesthetic drugs•
Severe allergic to eggs and soy (in relation to propofol)•
Abnormal responses to non-depolarized musculoskeletal muscle relaxants such as myasthenia gravis and musculoskeletal disorders, addiction (Narcotics, stimulants and energetic and alcohol)
Lake of patient satisfaction to participate in the study
Central and peripheral nervous diseases - Multiple trauma
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are randomly (using computer software) divided into two groups of 30 cases (A and B). Using a computer, random numbers are generated between 0 and 1. If the generated random number is less than 0.5, the patient is assigned to group A, and if it is greater than 0.5, the patient is assigned to group B.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study patients and investigator are not inform of the treatment groups allocation. Treatment is written on a piece of paper and puts into one envelope and is encrypted confidentially by supervisor.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-03-11, 1397/12/20
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Ethics committee reference number
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IR.QUMS.REC.1397.405
Health conditions studied
1
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Description of health condition studied
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Post operative shivering
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ICD-10 code
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Y55.2
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ICD-10 code description
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Post operative shivering
Primary outcomes
1
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Description
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Postoperative Shivering
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Timepoint
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After surgery
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Method of measurement
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Shivering is evaluated based on the 0-3 scale. Zero (without shivering), grade 1 (mild), grade 2 (moderate), and grade 3 (Severe).
Intervention groups
1
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Description
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Intervention group: Group A: Atracurium is injected intravenously with an initial dose of 0.5- 0.6 mg / kg and a concentration of 25 to 50 mg /ml. A preservative dose for muscle relaxation is injected intravenously with dose of 0.1- 0.2 mg/kg upon the onset of muscle relaxation. Company: Caspian.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: Group B: Cisatracurium is injected intravenously with an initial dose of 0.15- 0.2 mg /kg body weight and a concentration of 2 to 10 mg /ml. A preservative dose for muscle relaxation is injected intravenously with dose of 0.03 mg /kg, 40-60 minutes after the initial dose and upon the onset of muscle relaxation. Company: Caspian.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Qazvin University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable