Comparison effects and Complications of propofol and isoflurane anesthesia for open cholecystectomy.
Design
A randomized, single blinded(patients are unaware of the kind of used anesthetic medication) clinical trial with parallel groups (first group: Isofluran Second group: Propofol) design, consisted of 60patients, enrollment between February 2021 and 2022.
Randomization of samples to each group will be done by random permuted blocks. according to the sample size, which is 60 people, the number of 6 blocks will be determined. And there will be an equal number of cards from each group in each block, the order in blocks will be in a random permutated method. Therefore, by performing each block, 10 patients will be selected.
Settings and conduct
The current study is a single centered clinical trial that will occur at Imam Ali Hospital in Zahedan. Patients will be divided into two intervention groups according to the permissive block randomization method. In this study patients are randomly divided into intervention groups after signing informed consent unawarely.
Participants/Inclusion and exclusion criteria
Participants: Patients who will undergo a cholecystectomy procedure
Inclusion criteria:
Age between 15 and 80 years old
American Society of Anesthesiologists (ASA) Class I & II
Exclusion criteria:
History of allergic reaction to these medication
Drug abuse
Common Cold
Heart and Renal diseases, Hypertension
Taking tranquilizer medication
Not signing informed consent to participate in the study
2failed attempts for Intubation
Intervention groups
First Intervention group: Isofluran group. Isofluran 1.5% 1.5MAC inhalation in Anesthesia time.
Second Intervention group, Propofol group: Intravenous propofol infusion 100 µg/Kg per min in anesthesia time
Main outcome variables
Blood Pressure؛ Heart Rate؛ Awakening time from anesthesia؛ Nausea & Vomiting؛ Hoarseness؛ Staying time in recovery room
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120817010617N6
Registration date:2021-01-13, 1399/10/24
Registration timing:prospective
Last update:2021-01-13, 1399/10/24
Update count:0
Registration date
2021-01-13, 1399/10/24
Registrant information
Name
morteza Sedaghat Kia
Name of organization / entity
zaums
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 9540
Email address
morimedico@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effects and Complications of propofol and isoflurane anesthesia for open cholecystectomy
Public title
Comparison effects and Complications of propofol and isoflurane anesthesia for open cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 15 and 80 years old
American Society of Anesthesiologists (ASA) Class I & II
Exclusion criteria:
History of allergic reaction to these medication
Drug abuse
Common Cold
Heart and Renal diseases, Hypertension
Taking tranquilizer medication
Not signing informed consent to participate in the study
Two failed attempts for Intubation
Age
From 15 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of samples to each group will be done by random permuted blocks. according to the sample size, which is 60 people, the number of 6 blocks will be determined. And there will be an equal number of cards from each group in each block, the order in blocks will be in a random permutated method. Therefore, by performing each block, 10 patients will be selected(5 from each group).
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients are not aware of the kind of used anesthetic medication
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
Zahedan University of Medical Sciences, Dr.Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
IR.ZAUMS.REC.1397.230
Health conditions studied
1
Description of health condition studied
Gallstone disease
ICD-10 code
K82.9
ICD-10 code description
Disease of gallbladder, unspecified
Primary outcomes
1
Description
Blood Pressure
Timepoint
Every 5 Minutes from beginning of intervention till the end of surgery
Method of measurement
Manometer
2
Description
Heart Rate
Timepoint
Every 5 Minutes from beginning of intervention till the end of surgery
Method of measurement
ECG Monitor
3
Description
Awakening time from anesthesia
Timepoint
When patient awakes and obeys
Method of measurement
Clinical Observation (Minutes)
4
Description
Nausea & Vomiting
Timepoint
After patients awakening In recovery room
Method of measurement
Observe and record in a data form
5
Description
Hoarseness
Timepoint
After patients awakening In recovery room
Method of measurement
Observe and record in a data form
6
Description
Staying time in recovery room
Timepoint
After patients awakening In recovery room
Method of measurement
clinical, record in a data form
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group, Isofluran group: Isofluran 1.5% 1.5MAC inhalation in Anesthesia time.
Category
Treatment - Drugs
2
Description
Second Intervention group, Propofol group: Intravenous propofol infusion 100 µg/Kg per minutes in anesthesia time