Protocol summary

Summary
The purpose of this study is to compare BIS Monitoring with Clinical Monitoring in recovery Model of patients undergoing open kidney surgery under general anesthesia. All patients undergoing open kidney surgery from March to October 2015 are enrolled. Patients are randomly divided two groups, BIS (B) and control (C). Both groups are anesthetized by an identical method. Anesthetic management of these patients involves the measurement of HR, NIBP, ECG and pulse oximetry at intervals of 5 minutes. Check the depth of anesthesia in Group C measure by checking the heart rate, blood pressure, tears, sweat and pupil size that if increase 20% from initial baseline or change in any of the cases cited, narcotic will inject into the patient. In Group B, BIS monitoring is used. BIS between 60-40 is considered normal and this range will be maintained for the entire duration of surgery. If BIS increased to over 60, despite initial administration of propofol, narcotic is injected into the patient. After surgery, the eye opening time, oral response to verbal stimuli time, extubation time, stay in recovery time, the total amount of narcotic injecting during and after surgery and the first time that use narcotic will record. All data will be analyzed using SPSS software.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042111766N2
Registration date: 2015-05-17, 1394/02/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-17, 1394/02/27
Registrant information
Name
Hossein Khoshrang
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 0028
Email address
khoshrang@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan university of medical sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison BIS Monitoring with Clinical Monitoring in recovery model of patients undergoing open kidney surgery under general anesthesia
Public title
Comparison BIS Monitoring with Clinical Monitoring in recovery model of patients undergoing open kidney surgery under general anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterion: all patients underwent kidney open surgery. Exclusion criteria: personality or neurological disorders; history of head trauma; drug abuse; use of drugs that affect the CNS; skull or frontal abnormalities; uncontrolled hypertension (SBP>160 or DBP>105); SBP<90; HR<55; Diabetes mellitus; BMI>33; emergency surgeries; ASA class ≥ II.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti Freeway
City
Rasht
Postal code
4193833697
Approval date
2015-03-17, 1393/12/26
Ethics committee reference number
1930003509

Health conditions studied

1

Description of health condition studied
Kidney open surgery
ICD-10 code
N19
ICD-10 code description
Unspecified kidney failure

Primary outcomes

1

Description
The eye opening time
Timepoint
At the time of recovery
Method of measurement
According to report of resident of anesthesiology

2

Description
The time of oral response to verbal stimuli
Timepoint
At the time of recovery
Method of measurement
According to report of resident of anesthesiology

3

Description
Extubation time
Timepoint
At the time of recovery
Method of measurement
According to report of resident of anesthesiology

4

Description
Stay in recovery time
Timepoint
At the time of recovery
Method of measurement
According to records

5

Description
Patient's VAS in recovery unit
Timepoint
At the time of recovery unit
Method of measurement
According VAS score

6

Description
The total amount of narcotic injecting
Timepoint
During and after surgery
Method of measurement
According to records

7

Description
The first time of injection of narcotic after surgery
Timepoint
At the time of recovery unit
Method of measurement
According to records

Secondary outcomes

empty

Intervention groups

1

Description
Checking depth of anesthesia measure by checking the heart rate, blood pressure, tears, sweat and pupil size
Category
Diagnosis

2

Description
Checking depth of anesthesia using BSI monitoring
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Hossein khoshrang
Street address
razi Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshti Freeway
City
Rasht
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 Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Hossein Khoshrang
Position
Anesthesiologist
Other areas of specialty/work
Street address
razi hospital
City
Rasht
Postal code
4139638459
Phone
+98 132238306
Fax
Email
aecguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Hossein Khoshrang
Position
Anesthesiologist
Other areas of specialty/work
Street address
Razi hospital
City
Rasht
Postal code
4193955599
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedyeh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir

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
Loading...