Comparison of the effect of low dosage of midazolam plus ketamine and low dose ketamine plus midazolam on postoperative shivering after spinal anesthesia.
Comparison of the prophylactic use of two different doses of Ketamine and Midazolam for prevention of shivering during spinal anesthesia.
Design
The first group receives 0.2 mg/kg of midazolam with ketamine 0.3 mg/kg, the second group receives 0.4 mg/kg of midazolam with low dose ketamine 0.15 mg/kg and the third group receives normal saline. A randomized double-blind clinical trial is conducted on 120 patients undergoing surgery with spinal anesthesia.
Settings and conduct
Patients are referred to al-Zahra hospital. The patients are randomly divided into three groups including those who receive low dose Midazolam with Ketamine (a), Midazolam with low dose Ketamine (b) and Normal saline (c). The Participants, Care provider, Outcome assessor, and Data analyser are not aware of the drug type and the investigator deciphers the codes after data analysis.
Participants/Inclusion and exclusion criteria
Included criteria: 18 to 45 years old; the physical condition of the ASAI-II; undergoing elective surgery under spinal anesthesia
Excluded criteria: allergic to the drug; blood transfusion; change the anesthesia method
Intervention groups
They are divided into three groups A, B, and C. The first group midazolam with ketamine, the second group received midazolam dosed with low dose ketamine and a third group received normal saline.
Main outcome variables
shivering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160307026950N8
Registration date:2018-07-27, 1397/05/05
Registration timing:retrospective
Last update:2018-07-27, 1397/05/05
Update count:0
Registration date
2018-07-27, 1397/05/05
Registrant information
Name
Behzad Nazemroaya
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3212 3543
Email address
behzad_nazem@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of low dosage of midazolam plus ketamine and low dose ketamine plus midazolam on postoperative shivering after spinal anesthesia.
Public title
Effects of low dosage of midazolam plus ketamine and low dose ketamine plus midazolam on shivering
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age 18 to 45 years old
Candidate for surgery
Anesthesia Technique Spinal Anesthesia
ASAI,ASAII
Exclusion criteria:
Change in Anesthesia Technique
Bleeding during blood transfiusion
Allergy to the drug
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to the 3 groups of A, B, and C using random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
All drugs are prepared and placed at the same volume and homogeneously into the syringes by the investigator. The hemodynamic changes (after the administration of each drug) are monitored and recorded. Moreover, the Participants, Care provider, Outcome assessor, and Data analyser are not
aware of the drug type and the investigator deciphers the codes after data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-24, 1396/03/03
Ethics committee reference number
ir.mui.rec.1396.3.364
Health conditions studied
1
Description of health condition studied
shivrring
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
shivering
Timepoint
Recovery Duration
Method of measurement
In minutes using the timer
2
Description
Temperature of Peripheral
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Skin Thermometer
3
Description
Central temperature
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Tympanic thermometer
4
Description
Heart Rate
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Electrocardiogram
5
Description
Mean Arterial Blood Pressure
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Non invasive blood pressure measurement
6
Description
Oxygen saturation
Timepoint
At the base time; after the procedure and then every 15 minutes until discharge of recovery.
Method of measurement
Pulse oximetry device
Secondary outcomes
1
Description
Duration of surgery
Timepoint
The time to start the surgery until the end of the surgery
Method of measurement
Minute
2
Description
Duration of stay in recovery
Timepoint
From admission to recovery until discharge
Method of measurement
Minute
3
Description
Nausea and Vomiting
Timepoint
During stay in recovery
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group B: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. In this group, low dose Midazolam and Ketamine are injected and subsequent shivering is checked.
Category
Prevention
2
Description
Intervention group C: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. In this group, low dose midazolam and ketamine are injected and induced shivering in them will be checked. In this group, low dose Ketamine and midazolam are injected and subsequent shivering in them is checked.
Category
Prevention
3
Description
Control group A: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. In this group, low dose Midazolam and Ketamine are injected subsequent shivering in them is checked. In this group, Normal saline is injected and resultant shivering in them is checked. In this group, Normal saline is injected and subsequent shivering in them is checked.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Soffeh boulivard, Shahid Kesari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghyegh Haghjoo
Street address
Hezar jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sara Azizollahi
Position
Medical student/ Intern
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Baghdaryache
City
Isfahan
Province
Isfehan
Postal code
7516769337
Phone
+98 37764766
Email
sazizollahi24@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 32247233
Email
b.nazemroaya@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ostandari
City
Isfahan
Province
Isfehan
Postal code
8146713543
Phone
+98 31 3224 7233
Email
b.nazemroaya@khuisf.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Only registered symptoms can be published without mentioning the names of the participants
When the data will become available and for how long
Starting the access period 6 months after printing results
To whom data/document is available
Only available to scholars working in academia and academia
Under which criteria data/document could be used
Written request via email and university approval
From where data/document is obtainable
By contacting the corresponding author
What processes are involved for a request to access data/document
After the email is received by the applicant, it takes one week to agree The university will be obtained and then will be notified to the requestor. Maximum of this process takes ten days.