Evaluating the effect of Bispectral Index (BIS) during anesthesia induction on the amount of propofol consumption in patients undergoing various surgical procedures
Design
In this randomized clinical trial study, patients will be selected by simple random sampling and will be divided into two groups by block randomization. According to the sample size of 80 (40 cases and 40 controls) there will be in 8 blocks of 10 individuals.
Settings and conduct
This study will be conducted in Zahedan University of Medical Sciences hospitals. Control group will be given general anesthesia based on clinical symptoms and treatment group based on Bispectral Index (BIS). ّFirst, both groups get the same amount of anesthetic drug. The control group will receive propofol 0.2mg every 20 seconds until there is no response to stimulation and complete anesthesia; the experimental group will receive 0.5 mg every 20 seconds until the BIS is reduced to less than 60. The amount of propofol during anesthesia induction, heart rate and mean arterial blood pressure will be recorded before and after intubation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- ASA Class I & II
2- Age between 18 and 65
Exclusion criteria:
1-History of problem in intubation
2-Loss of consciousness before surgery
3-Brain surgery
4-Cardiovascular disease
5-Esophageal reflex
6-Hiatus hernia
7-liver or renal failure
8-sensitivity to the drugs
9-Sedative or substance administration within 24 hours before surgery
10-History of any neurological disorders and use of psychiatric drugs
11-Patient history of addiction
12- hemoglobin < 10 mg/dL
13-Patient dissatisfaction with study participation
Intervention groups
Experimental group (using BIS)
Control Group (non BIS)
Main outcome variables
Amount of propofol
Mean arterial pressure
Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190813044521N1
Registration date:2019-11-23, 1398/09/02
Registration timing:prospective
Last update:2019-11-23, 1398/09/02
Update count:0
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
MARYAM HOJJAT
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3221 0940
Email address
maryyhojjat@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2640-12-22, 2019/10/01
Expected recruitment end date
2641-10-23, 2020/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the Bispectral Index (BIS) during induction of anesthesia on the amount of propofol in patients undergoing various surgical procedures.
Public title
The effect of the Bispectral Index (BIS) on the drug dosage during induction of anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- ASA Class I & II
population between the ages of 18 and 65
Exclusion criteria:
-History of intubation problem before or in doubt
Loss of consciousness before surgery without reason
Brain surgery
Cardiovascular disease
Esophageal reflax6-
Hiatus hernia
liver or renal failure
sensitivity to the drugs
Sedative or substance administration within 24 hours before surgery
History of any neurological disorders and use of psychiatric drugs
Patient history of addiction1
hemoglobin < 10 mg/dL
Patient dissatisfaction with study participation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
Block randomization with two group treatment (A and B), and block size equal 8 with 80 sample size (40 sample in each group) based random allocation generated by soft wear will be use. Base this method, create 10 blocks to assign sample numbers equally to each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.ZAUMS.REC.1398.199
Health conditions studied
1
Description of health condition studied
Elective general anesthesia
ICD-10 code
Y70.0
ICD-10 code description
Diagnostic and monitoring anesthesiology devices associated with adverse incidents
Primary outcomes
1
Description
amount of propofol
Timepoint
20 seconds
Method of measurement
Syringe
2
Description
Mean arterial pressure
Timepoint
before induction (baseline), immediate after induction, immediate after intubation, and 5 min after intubation
Method of measurement
Sphygmomanometer
3
Description
heart beat
Timepoint
before induction (baseline), immediate after induction, immediate after intubation, and 5 min after intubation
Method of measurement
heart rate monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use of a bispectral index (BIS)
Category
Treatment - Devices
2
Description
Control group: Without Use of a bispectral index (BIS)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences Hospitals
Full name of responsible person
Sharam Bojian Borujeni
Street address
Imam Ali Teaching Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
maryyhojjat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nour Mohamad Bakhshani
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
maryyhojjat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Hojjat
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
0098 54 33295570-80
Email
maryyhojjat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Hojjat
Position
Nesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
0098 54 33295570-80
Email
maryyhojjat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Maryam Hojjat
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
0098 54 33295570-80
Email
maryyhojjat@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
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