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The Comparison of inhaled and intravenous anesthesia on depth of anesthesia and hemodynamic changing in Cholecystectomy Laparoscopic.

Protocol summary

Summary
Purpose:Stady of effect of tow inhalant and venous anesthesia on depth of anesthesia and hemodynamic changing in laparoscopic cholecystectomy. Study design:block Randomized, double-blind, placebo without control, Single Central The study population:Our study population consisted of patients 20-40 years candidate for laparoscopic cholecystectomy hospitalized Shohada Hospital Ashaier in Khorram Abad. Inclusion criteria:All patients 20 to 40 years undergoing laparoscopic cholecystectomy referred to Shohada hospital in Khorramabad in the second half of 2015. Exclusion criteria:Lack of consent to participate in research projects, heart problems, allergies to eggs, a history of sensitivity to anesthesia, conversion laparoscopic surgery to open surgery of cholecystectomy, high blood pressure, history of diabetes. The sample size: 92 Patients were randomized to two groups of blocks allocated:Group T to receive intravenous anesthesia And V group to receive inhalation anesthesia. In the operating room patients catheterized and intravenous fluids injected .Prodrug is contains 2 ml narcotic sufentanil and 2 mg midazolam.Induction of anesthesia is done by sodium thiopental and atracurium, Then intubation is performed,Changes in blood pressure and heart rate and depth of anesthesia of patients constantly monitoring,Maintenance of anesthesia in Group T perform with propofol 100 micrograms per kilogram of body weight per minute and in Group v with Sevoflurane 1.2%,By neostigmine and atropine awakening is done. The main outcomes: blood pressure, heart rate, depth of anesthesia.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015092716516N2
Registration date: 2015-11-25, 1394/09/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-25, 1394/09/04
Registrant information
Name
Sadeghe Nadri
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 3004
Email address
dr.s.nadri@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of lorestan University of Medical Sciences
Expected recruitment start date
2015-10-07, 1394/07/15
Expected recruitment end date
2016-01-05, 1394/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of inhaled and intravenous anesthesia on depth of anesthesia and hemodynamic changing in Cholecystectomy Laparoscopic.
Public title
The Comparison of inhaled and intravenous anesthesia on depth of anesthesia and hemodynamic changing in Cholecystectomy Laparoscopic.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:All patients 20 to 40 years undergoing laparoscopic cholecystectomy referred to Shohada hospital in Khorramabad in the second half of 1394. Exclusion criteria:Lack of consent to participate in research projects, heart problems, allergies to eggs, a history of sensitivity to anesthesia, conversion laparoscopic surgery to open surgery, cholecystectomy, high blood pressure, history of diabetes.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Method randomization: block Randomized

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Lorestan University of Medical Sciences
Street address
Lorestan،Khorramabad،Lorestan University of Medical Sciences
City
Khorramabad
Postal code
381251698
Approval date
2015-09-22, 1394/06/31
Ethics committee reference number
LUMS.REC.1394.24

Health conditions studied

1

Description of health condition studied
General anesthesia
ICD-10 code
K80-K87
ICD-10 code description
Disorders of gallbladder, biliary tract and pancreas

Primary outcomes

1

Description
blood pressure
Timepoint
Before induction of anesthesia, after premedication injection, after induction of anesthesia, after intubation, during surgery four times, after extubation،And with an interval of every 15 minutes.
Method of measurement
Millimeters of mercury using a sphygmomanometer

2

Description
heart rate
Timepoint
Before induction of anesthesia, after premedication injection, after induction of anesthesia, after intubation, during surgery four times, after extubation،؛And with an interval of every 15 minutes.
Method of measurement
Depending on the number of beats per minute monitoring device

3

Description
Depth of Anesthesia
Timepoint
Before induction of anesthesia, after premedication injection, after induction of anesthesia, after intubation, during surgery four times, after extubation،And with an interval of every 15 minutes.
Method of measurement
Based on the electrical brain waves and by BIS device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In the operating room patients catheterized and intravenous fluids injected .Prodrug is contains 2 ml narcotic sufentanil and 2 mg midazolam.Induction of anesthesia is done by sodium thiopental and atracurium, Then intubation is performed,In this group (Group T), maintenance of anesthesia perform with propofol 100 mg per kg of body weight per minute. Manufacturer: pharmaceutical company of dongkook, Manufactured by country of Korea
Category
Treatment - Surgery

2

Description
Control group: In the operating room patients catheterized and intravenous fluids injected .Prodrug is contains 2 ml narcotic sufentanil and 2 mg midazolam.Induction of anesthesia is done by sodium thiopental and atracurium, Then intubation is performed,In this group (Group v), maintenance of anesthesia perform withwith Sevoflurane 1.2%. Manufacturer: pharmaceutical company of BAXTER, Manufactured by country of GUAYAMA
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
S. Nadri doctor, a specialist in anesthesia, Assistant Professor
Street address
Lorestan,Khorramabad, Shohada hospital
City
Khorramabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of lorestan University of Medical Sciences
Full name of responsible person
dr.morovvat taheri kalani,Vice Chancellor for research of lorestan University of Medical Sciences
Street address
Vice Chancellor for research of lorestan University of Medical Sciences,5 km road Boroujerd Khorramabad
City
Khorramabad
Grant name
_
Grant code / Reference number
_
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of lorestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Deputy of Research, Lorestan University of Medical Sciences
Full name of responsible person
Farzad Mohammadi
Position
medical student
Other areas of specialty/work
Street address
Lorestan, Khorramabad, Lorestan University of Medical Sciences Research Department
City
Khorramabad
Postal code
381251698
Phone
+98 66 3322 3004
Fax
Email
farzad871410053@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Deputy of Research, Lorestan University of Medical Sciences
Full name of responsible person
S. Nadri doctor
Position
General anesthesia specialist, assistant professor
Other areas of specialty/work
Street address
Lorestan, Khorramabad, Lorestan Medical Sciences University Research Assistant
City
Khorramabad
Postal code
381251698
Phone
+98 66 3322 3004
Fax
Email
dr.s.nadri@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Deputy of Research, Lorestan University of Medical Sciences
Full name of responsible person
Farzad Mohammadi
Position
medical student
Other areas of specialty/work
Street address
Lorestan, Khorramabad, Lorestan Medical Sciences University Research Assistant
City
Khorramabad
Postal code
381251698
Phone
+98 66 3322 3004
Fax
Email
farzad871410053@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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