Protocol summary

Study aim
Comparison the effect of propofol and isoflurane on hemodynamics parameters and stress response hormones during laparoscopic cholecystectomy.
Design
Patients are randomly divided into two intervention groups and the study is design as a randomised, parallel group trial with single blinded outcome assessment.
Settings and conduct
Seventy patients candidate of laparoscopic cholecystectomy in age group 20 to 60 years are randomly divided into intervention (1) and (2) group. The combination of midazolam (0.05 mg/kg), fentanyl (2 µg/kg), sodium thiopental (4 mg/kg), atracurium (0.5 mg/kg) is used to induce anesthesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria are patients with symptomatic gallstone disease or acute cholecystitis, patients without inside or outside biliary tract dilatation and American Society of Anesthesiologists (ASA) classification I , II; The exclusion criteria are obesity patients with class II or III (BMI>35), patients with chronic liver disease, diabetes, renal failure, endocrine problems, rheumatoid arthritis, cardiovascular disease or malignancy, patients receiving drugs with known effects on sympathetic response or hormone secretion, patients receiving benzodiazepines and pregnant or lactating mothers.
Intervention groups
In the Intervention group (1), intravenous injection of propofol 50-150 µg/kg/min is performed and in the intervention group (2), isoflurane with mac: 1.28% atm/mmhg is vaporized and patients inhale.
Main outcome variables
Mean arterial pressure and heart rate in time of starting the operation, every 5 minutes during the time between start of surgery till the completion of the surgical operation and 20 minutes after attending to recovery room are measured. Epinephrine and blood glucose level are measured via blood test before starting the operation (after anesthesia induction) and after finish running suturing (before reverse).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190222042806N1
Registration date: 2019-09-25, 1398/07/03
Registration timing: registered_while_recruiting

Last update: 2019-09-25, 1398/07/03
Update count: 0
Registration date
2019-09-25, 1398/07/03
Registrant information
Name
Elham Sheyda Golbad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 0168
Email address
sheyda.e@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the Effect of Propofol and Isoflurane on Hemodynamics Parameters and Stress Response Hormones during Laparoscopic Cholecystectomy
Public title
The Effect of Propofol and Isoflurane on Hemodynamics Parameters and Stress Response Hormones during Laparoscopic Cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with symptomatic gallstone disease Patients with acute cholecystitis Patients without inside or outside biliary tract dilatation American Society of Anesthesiologists (ASA) classification I , II
Exclusion criteria:
Obesity patients with class II or III (BMI>35) Patients with chronic liver disease, diabetes, renal failure, endocrine problems, rheumatoid arthritis, cardiovascular disease or malignancy Patients receiving drugs with known effects on sympathetic response or hormone secretion such as Beta-blockers Patients receiving benzodiazepines Pregnant or lactating mothers
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups based on simple randomization method using random digits table. In this method, a collection of non-template numbers is randomly generated and arranged as a table. Even numbers for the intervention group (1) and the odd numbers for the intervention group (2) are considered. According to the number of patients, they are randomly assigned to one of the intervention groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Responsible for collecting data, data analyzer
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Research deputy, Ahvaz Jundishapur University Of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-11-24, 1397/09/03
Ethics committee reference number
IR.AJUMS.REC.1397.631

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
Mean arterial pressure (MAP(
Timepoint
Time of starting the operation, every 5 minutes during the time between start of surgery till the completion of the surgical operation and 20 minutes after attending to recovery room
Method of measurement
Gauge pressure

2

Description
Heart rate
Timepoint
Time of starting the operation, every 5 minutes during the time between start of surgery till the completion of the surgical operation and 20 minutes after attending to recovery room
Method of measurement
Electrocardiograph signal

3

Description
Epinephrine level
Timepoint
Before starting the operation (after anesthesia induction) and after finish running suturing (before reverse)
Method of measurement
Blood test

4

Description
Blood glucose
Timepoint
Before starting the operation (after anesthesia induction) and after finish running suturing (before reverse)
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group (1): Intravenous injection of propofol 50-150 µg/kg/min is performed.
Category
Treatment - Drugs

2

Description
Intervention group (2): Isoflurane with mac: 1.28% atm/mmhg is vaporized and patients inhale.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ali Ghomeishi
Street address
Razi Hospital, Palestin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 5935
Email
Alighomeishi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
PAIN-9710
Grant code / Reference number
330094424
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Elham Shayda Golbad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Razi Hospital, Palestin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 5935
Email
elham.sh.golbad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Ghomeishi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Razi Hospital, Palestin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 5935
Email
Alighomeishi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Elham Shayda Golbad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Razi Hospital, Palestin Ave.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 5935
Email
elham.sh.golbad@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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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