Comparison effects of intravenous ketamine with intrathecal meperidine in prevention of shivering in elective orthopedic surgery of lower extremity with spinal anesthesia
Effect of meperedin intratecal in shivering after spinal anesthesia
Design
This study is a clinical trial with control group (phase 3), randomized (using computer random number list) and double-blind. The statistical population of this study is 150 patients who are candidates for spinal anesthesia in orthopedic lower limb surgeries in Imam Khomeini Hospital in Sari during the years 2017-2018.
Settings and conduct
The study was performed on patients who are candidates for spinal anesthesia in orthopedic lower limb surgery at Imam Khomeini Hospital in Sari. In the operating room, patients were given 5 ml per kg of normal saline at 37 ° C, 30 minutes before spinal anesthesia. Systolic and diastolic blood pressure and mean arterial pressure, heart rate and peripheral oxygen saturation and chills and body temperature were measured by sublingual thermometer 3 minutes before spinal anesthesia and then measured and recorded at 20 minute intervals.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient's desire to participate in the study and gain informed consent؛ Age 18-65 years; Not fever.
Exclusion criteria: Patients who received blood and blood products during surgery; Allergic reaction to meperidine or ketamine.
Intervention groups
Group K: Bupivacaine 0.5% 15 mg, which was increased to 4 ml with normal saline, was injected intrathecally, and immediately after spinal anesthesia, ketamine 0.5 mg / kg, which was reduced to 5 ml with normal saline. It was injected intravenously.
Group M: bupivacaine 0.5% 15 mg and meperidine 0.2 mg / kg which was increased to 4 ml with normal saline and injected intrathecally and 5 ml normal saline was injected intravenously.
Group C: Normal saline 5 ml intravenously and bupivacaine 0.5% 15 mg with normal saline volume 4 cc was injected intrathecally.
Main outcome variables
Shivering; Nausea and Vomiting؛ Heart rate drop.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160403027191N3
Registration date:2020-12-07, 1399/09/17
Registration timing:retrospective
Last update:2020-12-07, 1399/09/17
Update count:0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Abdolmajid Gholinataj Jelodar
Name of organization / entity
Mazandaran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3304 4000
Email address
gholinataj54@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2019-01-21, 1397/11/01
Trial completion date
2019-01-21, 1397/11/01
Scientific title
Comparison effects of intravenous ketamine with intrathecal meperidine in prevention of shivering in elective orthopedic surgery of lower extremity with spinal anesthesia
Public title
Effect of Meperedin and Ketamin in prevention of shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's desire to participate in the study and gain informed consent
Elective lower extremity orthopedic surgery under spinal anesthesia
Age>18and Age<65
ASA 1 and 2
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
150
Actual sample size reached:
150
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 150 patients were randomly divided into three groups: intervention Ketamine (K), intervention Meperidine (M) and control group (C) using a list of computer random numbers. This was done by an anesthesia technician who was a fellow project.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was double-blind and the statistician, project physicians and patients were unaware of the patients' placement in the treatment groups and the data collection form was filled in by the project partner nurse who was unaware of the study groups. The lead researcher who injects the drug, as well as the medical staff responsible for caring for patients, are blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Anesthesiology department ,Emam Khomeini Hospiral, Amir Mazandarani street
City
Sari
Province
Mazandaran
Postal code
48166-33131
Approval date
2016-04-29, 1395/02/10
Ethics committee reference number
Ir.mazums.rec.95.2400
Health conditions studied
1
Description of health condition studied
Shivering
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of shivering
Timepoint
From three minutes after the onset of anesthesia to two hours later at twenty-minute intervals
Method of measurement
Shivering chart
Secondary outcomes
1
Description
Body temperature
Timepoint
From three minutes after spinal anesthesia to two hours later at intervals of every twenty minutes
Method of measurement
Termometr
2
Description
Mean Arterial Pressure
Timepoint
From three minutes after spinal anesthesia to two hours later at intervals of every twenty minutes
Method of measurement
Saadat automatic pressure gauge
Intervention groups
1
Description
Group K: Bupivacaine 0.5% 15 mg, which was increased to 4 ml with normal saline, was injected intrathecally, and immediately after spinal anesthesia, ketamine 0.5 mg / kg, which was reduced to 5 ml with normal saline. It was injected intravenously.
Category
Treatment - Drugs
2
Description
Intervention group: Group M: bupivacaine 0.5% 15 mg and meperidine 0.2 mg / kg which was increased to 4 ml with normal saline and injected intrathecally and 5 ml normal saline was injected intravenously.
Category
Treatment - Drugs
3
Description
Control group:Group C: Normal saline 5 ml intravenously and bupivacaine 0.5% 15 mg with normal saline volume 4 cc was injected intrathecally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Abdolmajid Gholinataj Jelodar
Street address
Department of Anesthesiology, Emam Khomeini hospital, Amir Mazandari street, Sari
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 5348
Email
gholinataj54@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid saeedi
Street address
Anesthesiology Department,Emam Khomeini Hospital,Amir Mazandarani street
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 5348
Email
gholinataj54@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Abdolmajid Gholi Nataj Jelodar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani street
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 5348
Fax
Email
gholinataj54@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abdolmajid Gholinataj Jelodar
Position
Assistant peofessor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani street
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 5348
Fax
Email
gholinataj54@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abdolmajid Gholinataj Jelodar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amir Mazandarani street
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 5348
Email
gholinataj54@mazums.ac.ir
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
The study has already been done and the data is not available