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General information
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133
133
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2019-05-22, 1398/03/01
2019-05-22 00:00:00
empty
2019-08-11, 1398/05/20
2019-08-11 00:00:00
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2019-08-18, 1398/05/27
2019-08-18 00:00:00
Recruitment centers
#1
Name of recruitment center - English: yas hospital
Name of recruitment center - Persian: بیمارستان یاس
Full name of responsible person - English: saghar samimi sadeh
Full name of responsible person - Persian: ساغر صمیمی سده
Street address - English: yas hospital,north Ostad Nejatollahi ave. Karim kan Zand street
Street address - Persian: خیابان کریمخان زند خیابان استادنجات اللهی شمالی بیمارستان یاس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1598718311
Phone: +98 21 4216 0310
Fax:
Email: sagharsamimi@yahoo.com
Web page address:
Name of recruitment center - English: Yas Hospital
Name of recruitment center - Persian: بیمارستان یاس
Full name of responsible person - English: Saghar Samimi Sadeh
Full name of responsible person - Persian: ساغر صمیمی سده
Street address - English: Yas Hospital,North Ostad Nejatollahi Ave. Karim Khan Zand Street
Street address - Persian: خیابان کریمخان زند خیابان استادنجات اللهی شمالی بیمارستان یاس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1598718311
Phone: +98 21 4216 0310
Fax:
Email: sagharsamimi@yahoo.com
Web page address:
Name of recruitment center - English: yas hospitalYas Hospital Name of recruitment center - Persian: بیمارستان یاس Full name of responsible person - English: saghar samimi sadehSaghar Samimi Sadeh Full name of responsible person - Persian: ساغر صمیمی سده Street address - English: yas hospital,northYas Hospital,North Ostad Nejatollahi aveAve. Karim kanKhan Zand streetStreet Street address - Persian: خیابان کریمخان زند خیابان استادنجات اللهی شمالی بیمارستان یاس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1598718311 Phone: +98 21 4216 0310 Fax: Email: sagharsamimi@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: mostafa mohaghegh
Full name of responsible person - Persian: مصطفی محقق
Street address - English: Yas hospital, north Ostad Nejatollahi ave, Karim Khan Zand street
Street address - Persian: خیابان کریمخان زند خیابان استاد نجات اللهی شمالی بیمارستان یاس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1598718311
Phone: +98 21 4216 0106
Fax:
Email: yashospital@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Shirin Niroomanesh
Full name of responsible person - Persian: شیرین نیرومنش
Street address - English: Yas hospital, North Ostad Nejatollahi Ave, Karim Khan Zand Street
Street address - Persian: خیابان کریمخان زند خیابان استاد نجات اللهی شمالی بیمارستان یاس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1598718311
Phone: +98 21 4216 0106
Fax:
Email: yashospital@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: mostafa mohagheghShirin Niroomanesh Full name of responsible person - Persian: مصطفی محققشیرین نیرومنش Street address - English: Yas hospital, northNorth Ostad Nejatollahi aveAve, Karim Khan Zand streetStreet Street address - Persian: خیابان کریمخان زند خیابان استاد نجات اللهی شمالی بیمارستان یاس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1598718311 Phone: +98 21 4216 0106 Fax: Email: yashospital@gmail.com Web page address:
Protocol summary
Study aim
Determination the effect of low doses of ketamine on prevention of shivering after abdominal hysterectomy
Design
A randomized, double-blind, placebo controlled clinical trial
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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
Main outcome variables
]ncidence and severity of postoperative shivering after TAH
General information
Reason for update
Acronym
IRCT registration information
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
Registration date
2019-05-25, 1398/03/04
Registrant information
Name
Saghar Samimi Sadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4216 0000
Email address
sagharsamimi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-08-11, 1398/05/20
Trial completion date
2019-08-18, 1398/05/27
Scientific title
Comparison between ketamine 0.25 mg/kg and ketamine 0.5 mg/kg for relieving postoperative shivering after elective abdominal hysterectomy
Public title
effect of ketamine on postoperative shivering
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 35 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
96
Actual sample size reached:
133
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly allocated to 1 of 3 treatment groups using balanced block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics and Clinical Studies Committee of Tehran University of Medical Sciences
Street address
Yas Hospital,North Ostad Nejatollahi Ave, Karim Khan Zand St.
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2018-01-02, 1396/10/12
Ethics committee reference number
١٣٩٦.٤١٢٠.IR.TUMS.MEDICINE.REC.
Health conditions studied
1
Description of health condition studied
post operative shivering
ICD-10 code
R68.8
ICD-10 code description
Other specified general symptoms and signs
Primary outcomes
1
Description
incidence and severity of post operative shivering
Timepoint
0-5-10-15-20-60-120, 240 minutes post operative
Method of measurement
the frequency of shivering will be recorded on a questionnaire
2
Description
severity of shivering will be determined and recorded based on 0-4 scoring system
Timepoint
0-5-10-15-20-60-120, 240 minutes post operative
Method of measurement
the severity of shivering will be recorded on a questionnaire
Secondary outcomes
1
Description
The need to treatment with pethidine
Timepoint
Each time in the first 4 hours after surgery That the patients request a pain killer medication
Method of measurement
Recording the consumption of pethidine in mg in a questionnaire by the nurse
2
Description
Changes in core body temperature during anesthesia.
Timepoint
Just before the anesthesia begins and 30, 60, 90, min after it and also at 0 and 15 min of recovery time.
Method of measurement
Using Walch Allyn Braun Pro 6000 Tympanic thermometer
Intervention groups
1
Description
Intervention group: :injection of 0/25 mg/kg ketamin intravenously with 2 cc volume, 20 minutes before the end of surgery
Category
Prevention
2
Description
Intervention group: injection of 0/5 mg/kg ketamin intravenously with 2 cc volume, 20 minutes before the end of surgery
Category
Prevention
3
Description
Control group: 2cc normal saline intravenously , 20 minutes before the end of surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Hospital
Full name of responsible person
Saghar Samimi Sadeh
Street address
Yas Hospital,North Ostad Nejatollahi Ave. Karim Khan Zand Street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0310
Email
sagharsamimi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shirin Niroomanesh
Street address
Yas hospital, North Ostad Nejatollahi Ave, Karim Khan Zand Street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0106
Email
yashospital@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Saghar Samimi Sadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yas hospital,North Ostad nejatollahi Ave. Karim Khan Zand Street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0310
Email
sagharsamimi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saghar Samimi Sadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yas Hospital,North Ostan Nejatollahi Ave. Karim Khan Zand Street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0310
Email
sagharsamimi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saghar Samimi Sadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Yas Hospital,north Ostad Nejatollahi Ave. Karim Khan Zand Street
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 42160310
Email
sagharsamimi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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