Compare the effect of Lavender essential oil and Alprazolam on deep of anesthesia and thermodynamic parameters during general anesthesia process
Design
Based on the inclusion criteria, patients will divide into 3 control and intervention groups (1 and 2) by simple random allocation method. Interventions in groups are single-blind, premed drug is given by the researcher to the patient and the person assessing the depth of anesthesia will be unaware of the type of intervention.
Settings and conduct
The study will be performed in the hospital setting, between the hours of 7–8 am (2–3 hours before surgery) for group 1, 0.5 mg oral alprazolam, and for group 2, Three drops of lavender on a clean cloth or dressing is inhaled inhaled for 15-20 minutes by patients and. Routine medications administered to the patient include midazolam 0.02 mg / kg, fentanyl 2 ug / kg, or sufenta 0.2 ug / kg for anesthesia initiation.
Participants/Inclusion and exclusion criteria
Patients choice in class I anesthesia, age group 20-50 years with no serious disease.
Intervention groups
In intervention group 1 (alprazolam), in intervention group 2 (lavender aromatherapy) and in the non-intervention control group, only vital signs and depth of anesthesia are evaluated.
Main outcome variables
In this study, vital signs such as heart rate, blood pressure (systolic, diastolic, and mean arterial pressure MAP), respiratory rate and SPO2 level will be assessed before administration of pre-medication, before anesthetic, and concurrent with anesthesia(per operative) and 5 minutes after surgery. Depth of anesthesia during surgery for 3 times (starting time of surgery, mid-surgery and finishing the last part of surgery) and also after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045659N1
Registration date:2019-12-28, 1398/10/07
Registration timing:prospective
Last update:2019-12-28, 1398/10/07
Update count:1
Registration date
2019-12-28, 1398/10/07
Registrant information
Name
Sefollah Alaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
alaei@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-04, 1398/10/14
Expected recruitment end date
2020-05-03, 1399/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effectiveness of Lavender essential oil and Alprazolam on anesthesia and hemodynamic parameters during general anesthesia process
Public title
effect of Lavender essential oil and Alprazolam on anesthesia and hemodynamic parameters during general anesthesia process
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Class I Anesthesia,
Age group 20-50 years
Not have serious illnesses and problems affecting body function and thermodynamics such as diabetes and cardiovascular disease
Exclusion criteria:
History of mental illness or brain injury,
current use of sedatives, opiates, psychotropics drugs, patients who do not cooperate,
history of allergies or olfactory problems,
pre- and inoperative body temperature rise,
use of medications effective on sleep (such as phenobarbital)
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Premeditation therapy with alprazolam for group 1 and aromatherapy for group 2, will be performed by the researcher in the morning of surgery day. while the person who asses the depth of anesthesia, will not be aware of groups and kind of Premed.
Placebo
Not used
Assignment
Parallel
Other design features
The current study aims to help expand the use of non-pharmacological methods in the anesthesia and surgery process.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences Ethics Committee
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Approval date
2019-11-18, 1398/08/27
Ethics committee reference number
IR.SEMUMS.REC.1398.202
Health conditions studied
1
Description of health condition studied
Fractures of various organs that are surgically repaired under anesthesia
ICD-10 code
S72.04
ICD-10 code description
Fracture of base of neck of femur
2
Description of health condition studied
Femoral neck fracture
ICD-10 code
S72.043
ICD-10 code description
Displaced fracture of base of neck of unspecified femur
Primary outcomes
1
Description
The depth of anesthesia is evaluated peroperation and immediately after surgery.
Timepoint
Depth of anesthesia during surgery for 3 times will be assessed. The assessment time is in starting of surgery, mid-surgery and finishing the last part of surgery and also after surgery, 5 minutes after being placed on the recovery bed .
Method of measurement
Depth of anesthesia is measured by the Bispectral index (BIS) device. The patient's blood pressure is also measured using a digital blood pressure monitor
Secondary outcomes
1
Description
Vital sign include the patient's breathing, pulse rate and blood pressure measured by the assessor as well as with the help of a digital Sphygmomanometer.
Timepoint
Vital signs will be measured before prescription medication, 5 minutes after surgery, before anesthesia, at the time of surgery, mid-surgery, and after the last part of the surgical intervention. . It will be also measured 5 minutes after surgery on the recovery bed.
Method of measurement
By the assessor as well as with the help of a digital Sphygmomanometer
Intervention groups
1
Description
2-3 hours before surgery premed will be administrated. For group 1, the dose of oral alprazolam is 0.5 mg.
Category
Treatment - Drugs
2
Description
Intervention group: 3 drops of lavender that is poured on a clean cloth or gauze and inhaled for 15-20 minutes.
Category
Treatment - Drugs
3
Description
Control group: As a control group, they receive only routine medications
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
All of the study samples will be selected from patients admitted to orthopedic surgery due to bone f
Full name of responsible person
سیف الله علائی
Street address
Amin
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3344 1022
Fax
+98 23 3344 1021
Email
alaei@semums.ac.ir
Web page address
https://semums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
محمد رضا عسگری
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3365 4190
Fax
+98 23 3365 4190
Email
rds@semums.ac.ir
Web page address
https://semums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Sefollah Alaei
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3365 4190
Fax
+98 23 3365 4191
Email
alaei@semums.ac.ir
Web page address
https://semums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Abolfazl Abdullah Pour
Position
Anesthesiologist and Faculty Member
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Amin
City
Semnan
Province
Semnan
Postal code
3519735763
Phone
009831420
Email
ّFelordce@yahoo.com
Web page address
https://semums.ac.ir.
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sefollah Alaei
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3365 4190
Fax
+98 23 3365 4191
Email
alaei@semums.ac.ir
Web page address
https://semums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Baseline data of participants' such as age, sex, and kind of disease, intervention, and outcomes could be available to others through the publication of articles
When the data will become available and for how long
It is available to everyone indefinitely by publishing the article
To whom data/document is available
research center of Semnan University of Medical Sciences and researchers in the field of anesthesiology and intensive care could access the anonymous documentation by providing appropriate reasons.
Under which criteria data/document could be used
The main finding data will be available to the public through articles. More detailed data will be made available to researchers and specialists through correspondence with the research team
From where data/document is obtainable
By contact with the Correspond author in the published articles
What processes are involved for a request to access data/document
Introduce himself and mentioning personal, professional and organizational characteristics as well as the reasons for accessing to more detailed information and how to use this information.
Comments
It seems that through the publication of the articles, the main research findings can be available to practitioners and researchers in anesthesiology and intensive care fields.