Comparison the effect of Tiva anesthesia with isoflurane on liver enzymes activity in patients undergoing laparoscopic cholecystectomy
Design
The study is a randomized double-blind clinical trial
Settings and conduct
Imam Ali Hospital of Bojnourd, North Khorasan University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: signing informed consent to participate in the study; has no history of anesthesia in the past 6 months; the patient's age is between 18 and 70 years old; be in accordance with ASA grade one or two grade anesthesia; no history of specific drug use; does not have a specific underlying disease such as liver disease.
Exclusion criteria: the patient needs more pharmacotherapy during acne surgery; patients may require cardiopulmonary resuscitation during surgery; inability to exit the endotracheal tube at the end of surgery; intraoperative bleeding; laparoscopic transformation to open excessive liver damage during surgery and surgeon manipulation.
Intervention groups
Atracurium (0.5 mg / kg) and propofol (2 mg / kg) are used to induce anesthesia. After 3 minutes of hyperventilating and intubation, anesthesia was administered in the first group of isoflurane 1.2 mg and in the second group propofol 100 µg / kg with remifenil. (0.1 mcg for body weight per minute) will be used. Surgery will then be performed on all patients by a laparoscopic specialist with a qualified general surgery specialist who is blind to the drugs. After surgery and discontinuation of anesthesia, a reversal of injection (neostecmin plus atropine) will be performed for all patients with the aim of restoring the patient's muscle strength and spontaneous ventilation.
Main outcome variables
Hepatic Enzyme ALT; Hepatic Enzyme AST; Hepatic Enzyme ALP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200122046216N1
Registration date:2020-02-10, 1398/11/21
Registration timing:registered_while_recruiting
Last update:2020-02-10, 1398/11/21
Update count:0
Registration date
2020-02-10, 1398/11/21
Registrant information
Name
Mahdieh Dartomi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3223 3231
Email address
m.dartomi@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-20, 1398/04/29
Expected recruitment end date
2020-02-18, 1398/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of TIVA and isoflurane on the activity of liver enzymes in patients undergoing laparoscopic cholecystectomy
Public title
Compare the effect of TIVA and isoflurane on the activity of liver enzymes in patients undergoing laparoscopic cholecystectomy
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Has no history of anesthesia in the past 6 months
The patient's age is between 18 and 70 years old
According to the ASA class, there will be one or two classes of anesthesia
Exclusion criteria:
The patient needs more medication during surgery
Bleeding during surgery
Laparoscopic change to laparotomy
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients' entry into this study will be a non-random sampling of "available" type. Then they will be divided into intervention and control groups randomly. The random number table will be used for the random specialization of the samples.
Blinding (investigator's opinion)
Double blinded
Blinding description
The research will be a non-random sampling of the type "available" and then divided into two intervention groups as randomized block allocation using the web system.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of North Khorasan of University of Medical Sciences
Street address
Shahriar Street - Research Assistant
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Approval date
2016-09-19, 1395/06/29
Ethics committee reference number
985/پ/95
Health conditions studied
1
Description of health condition studied
Laparoscopic Cholecystectomy Surgery
ICD-10 code
K81
ICD-10 code description
Cholecystitis
Primary outcomes
1
Description
Anesthesia by Tiva
Timepoint
Time to start anesthesia
Method of measurement
Mg / kg body weight
2
Description
Isoflurane Anesthesia
Timepoint
Anesthesia maintenance time
Method of measurement
Mac Anesthetic Evaporator
3
Description
ALT Liver Enzyme
Timepoint
Hepatic enzyme activity preoperatively and postoperatively and 24 and 48 hours postoperatively
Method of measurement
Biochemical Autoanalysis Device
4
Description
AST Liver Enzyme
Timepoint
Hepatic enzyme activity preoperatively and postoperatively and 24 and 48 hours postoperatively
Method of measurement
Biochemical Autoanalysis Device
5
Description
ALP Liver Enzyme
Timepoint
Hepatic enzyme activity preoperatively and postoperatively and 24 and 48 hours postoperatively
Method of measurement
Biochemical Autoanalysis Device
Secondary outcomes
empty
Intervention groups
1
Description
After the patient enters the operating room, the supine position extends over the operating room bed and is monitored initially. An oximeter probe and pressure gauge cuff are attached to the patient's hand and a ringer serum is provided to the patient. Midazolam (2 mg) and fentanyl (100 mcg) were administered in all patients. Atracurium (0.5 mg / kg) and propofol (2 mg / kg) are used to induce anesthesia. After 3 minutes of hyperventilating the patient and performing the intubation, isoflurane inhaler anesthetic of 1.2 mc is used to maintain anesthesia in the first group.
Category
Treatment - Drugs
2
Description
After the patient enters the operating room, the supine position extends over the operating room bed and is monitored initially. An oximeter probe and pressure gauge cuff are attached to the patient's hand and a ringer serum is provided to the patient. Midazolam (2 mg) and fentanyl (100 mcg) were administered in all patients. Atracurium (0.5 mg / kg) and propofol (2 mg / kg) are used to induce anesthesia. After 3 minutes hyperventilating the patient and performing the intubation, propofol intravenous anesthetic is administered in the anesthetic phase of 100 micrograms per kg body weight plus remifanil (0.1 micrograms per minute body weight).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital of Bojnourd University of Medical Sciences
Full name of responsible person
Javad Shahinfar
Street address
Dolat Square - Headquarters of North Khorasan University of Medical Sciences
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7095
Email
m.dartomi@nkums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Seyed Kaveh Hojjat
Street address
Shahriar Street - Next to Imam Ali Hospital - Research Assistant
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7095
Email
k.hojjat@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Mahdieh Dartomi
Position
Master of Medical Education, Anesthesiology Department, School of Nursing, North Khorasan University
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Shahriar Street - Bojnurd School of Nursing
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7095
Email
dartoomi1369m@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mahdieh Dartomi
Position
Master of Medical Education, Anesthesiology Department, School of Nursing, North Khorasan University
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Bojnurd School of Nursing, Shahriar Street
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7095
Email
dartoomi1369m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Mahdieh Dartomi
Position
Master of Medical Education, Anesthesiology Department, School of Nursing, North Khorasan University
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Bojnurd School of Nursing, Shahriar Street
City
Bojnurd
Province
North Khorasan
Postal code
74877-94149
Phone
+98 58 3229 7095
Email
dartoomi1369m@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
After the end of the study some data and information will be loaded.
When the data will become available and for how long
6 months after plan completion
To whom data/document is available
Universities and scientific institutes
Under which criteria data/document could be used
Citing the source
From where data/document is obtainable
Email to responsible and consent
What processes are involved for a request to access data/document
It will take up to two months for email to be answered.