Protocol summary
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Study aim
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Determination the effect of low doses of ketamine on prevention of shivering after abdominal hysterectomy
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Design
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A randomized, double-blind, placebo controlled clinical trial
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Settings and conduct
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The site of research is Yas Hospital.After approval by the Ethics and Clinical
Studies Committee of Tehran University of Medical Science the investigation will be started.Informed consents will be obtained from all of the patients.All the patients will be anesthetized with standard method The study drugs are being prepared by a person who is not subsequently involved in the research and will be packed in an envelope that the patient code has been written on it and 20 minutes before the end of operation will be opened and injected .The anesthesiologist of operation room and all operation and recovery room nurses and the nurses responsible for the questionnaire are unaware of the type of drug and the patient group.After awakening, the severity and frequency of shivering and analgesic request will be recorded for up to 4 hours. At the end of the study, the incidence and severity of shivering between the groups will be compared.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:Women aged 35-65,elective abdominal hysterectomy candidate, ASA class 1-2,
benign diagnosis
Exclusion criteria: surgery time more than 3 hours; Abnormal hemorrhage or transfusion during surgery ,diagnosis of malignancy, symptom of arrhythmia ,liver ,kidney ,psychotic diseases and hypertension Unwillingness to work with scholars
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Intervention groups
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group 1 : 0/25 mg/kg ketamin intravenously with 2 cc volume, 20 minutes before the end of surgery
group 2: 0/5 mg/kg ketamin intravenously with 2 cc volume, 20 minutes before the end of surgery
group 3: 2cc normal saline intravenously , 20 minutes before the end of surgery
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Main outcome variables
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]ncidence and severity of postoperative shivering after TAH
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:
IRCT20190409043219N1
Registration date:
2019-05-25, 1398/03/04
Registration timing:
registered_while_recruiting
Last update:
2019-08-18, 1398/05/27
Update count:
1
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Registration date
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2019-05-25, 1398/03/04
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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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2019-05-22, 1398/03/01
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Expected recruitment end date
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2019-10-23, 1398/08/01
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Actual recruitment start date
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2019-05-22, 1398/03/01
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Actual recruitment end date
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2019-08-11, 1398/05/20
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Trial completion date
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2019-08-18, 1398/05/27
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Scientific title
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Comparison between ketamine 0.25 mg/kg and ketamine 0.5 mg/kg for relieving postoperative shivering after elective abdominal hysterectomy
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Public title
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effect of ketamine on postoperative shivering
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
female
35-65 yrs
ASA class 1-2
benign diagnosis
without any symptom of arrhythmia ,liver disease,kidney disease,psychotic disease and hypertension
Exclusion criteria:
surgery time more than 3 hrs
abnormal bleeding or need to transfusion through the surgery till 48 hrs after the ending of procedure or
taking hypnotic drugs from 72 hrs before the procedure
diagnosis of malignancy
refuse to cooperate with researchers
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Age
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From 35 years old to 65 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
96
Actual sample size reached:
133
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients were randomly allocated to 1 of 3 treatment groups using balanced block randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The study medications are prepared by an anesthesiologist who does not otherwise participated in the study and then are enveloped and sealed and patient′s code are recorded on it. The envelopes will open in operation room 20 min before the end of surgery by an anesthesiologist who is blinded to patient′s study group and type of solution. All of the nurses and patients are blinded to the type of solution and to the patient′s study group allocation.also the nurse who fill the questionnaire.
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Placebo
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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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2018-01-02, 1396/10/12
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Ethics committee reference number
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١٣٩٦.٤١٢٠.IR.TUMS.MEDICINE.REC.
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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R68.8
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ICD-10 code description
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Other specified general symptoms and signs
Primary outcomes
1
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Description
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incidence and severity of post operative shivering
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Timepoint
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0-5-10-15-20-60-120, 240 minutes post operative
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Method of measurement
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the frequency of shivering will be recorded on a questionnaire
2
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Description
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severity of shivering will be determined and recorded based on 0-4 scoring system
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Timepoint
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0-5-10-15-20-60-120, 240 minutes post operative
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Method of measurement
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the severity of shivering will be recorded on a questionnaire
Secondary outcomes
1
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Description
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The need to treatment with pethidine
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Timepoint
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Each time in the first 4 hours after surgery That the patients request a pain killer medication
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Method of measurement
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Recording the consumption of pethidine in mg in a questionnaire by the nurse
2
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Description
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Changes in core body temperature during anesthesia.
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Timepoint
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Just before the anesthesia begins and 30, 60, 90, min after it and also at 0 and 15 min of recovery time.
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Method of measurement
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Using Walch Allyn Braun Pro 6000 Tympanic thermometer
Intervention groups
1
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Description
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Intervention group: :injection of 0/25 mg/kg ketamin intravenously with 2 cc volume, 20 minutes before the end of surgery
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Category
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Prevention
2
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Description
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Intervention group: injection of 0/5 mg/kg ketamin intravenously with 2 cc volume, 20 minutes before the end of surgery
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Category
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Prevention
3
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Description
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Control group: 2cc normal saline intravenously , 20 minutes before the end of surgery
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Category
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Placebo
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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Tehran 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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no more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available