Comparison of anesthesia depth monitoring by conventional and bispectral index on incidence and severity of nausea and vomiting after urologic surgeries
The objective of this study is comparison of anesthesia depth monitoring by conventional and bispectral index on nausea and vomiting after urologic surgery. 180 participants who are candidate for abdominal urologic surgery at the single center with age range 20 to 60 years and The American Society of Anesthesiologists Physical Status classification I-II enroll in this phase3 clinical trial. Exclusion criteria is major comorbidity, prolonged operating time more than 2 hours and peritoneal manipulation. Patients and researchers who collect data blind of anesthesia depth monitoring kind. Patients before induction of anesthesia randomize to two groups with and without bispectral index monitoring. All steps before and during induction of anesthesia and the kind of using drugs is same in two groups. Drugs infusion set for bispectral index 40 -60 in the interventional group and in the control group, drugs infusion set to maintain heart rate and blood pressure in the range ±20% of baseline. During the first 24 hours after surgery, the incidence and severity of nausea and vomiting records for each patient. The same antiemetic drugs use if needed and prescription dose record every time. Incidence and severity of nausea and vomiting record every 30 minutes for 2 hours and every 6 hours to 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042312668N2
Registration date:2016-05-29, 1395/03/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-29, 1395/03/09
Registrant information
Name
Reza Sari motlagh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1545 1054
Email address
motlagh.reza.dr@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anesthesia depth monitoring by conventional and bispectral index on incidence and severity of nausea and vomiting after urologic surgeries
Public title
the effect of anesthesia depth on nausea and vomiting after surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Candidate for abdominal urologic surgery under general anesthesia; The American Society of Anesthesiologists (ASA) Physical Status classification I-II; Age range is 20 to 60 years. Exclusion criteria: Comorbidity such as liver disease, kidney disease, cardiovascular disease, central nervous system disease, gastrointestinal disease, pulmonary disease, metabolic disease and glaucoma; Blood transfusion need in operating time; Prolonged operating time (over than 2 hours); Past history of drugs hypersensitivity to using drugs; Drug history of emetic and anti-emetic drugs prior surgery; Pregnant or lactating women; Intraperitoneal surgery; Need to O2 therapy after surgery; Body mass index over than 30; motion sickness disease.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients and researchers who collect data is blinded from the anesthesia depth monitoring kind. The Two blocks with 90 fixed numbers is selected and two groups is randomized by Random Block of the sata" software
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2015-10-12, 1394/07/20
Ethics committee reference number
TBZMED.REC.1394.607
Health conditions studied
1
Description of health condition studied
Nausea and Vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and Vomiting
Primary outcomes
1
Description
Incidence and severity of nausea and vomiting after surgery
Timepoint
every 30 minutes for 2 hours and every 6 hours to 24 hours after surgery.
Method of measurement
Questionnari and graded visual scale
Secondary outcomes
1
Description
Decreased use of antiemetic drugs after surgery
Timepoint
Every 30 minutes for 2 hours and every 6 hours to 24 hours after surgery.
Method of measurement
Questionnaire
Intervention groups
1
Description
Traditional anesthesia depth monitoring
Category
Prevention
2
Description
Anesthesia depth monitoring by bispectral index
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Medical Research and Training Hospital
Full name of responsible person
Dr. Hamzeh Hoseinzadeh
Street address
Imam Reza Medical Research and Training Hospital, golgasht street.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hasan Soleimanpour
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Golgasht street.
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reihan Shenasi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Unite 2, Elit appartment, Skandari Alley, Nezami street, Vali-e-Asr street.
City
Tabriz
Postal code
Phone
+98 41 3329 4084
Fax
Email
reihan.shenasi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamzeh Hoseinzadeh
Position
Associated professor
Other areas of specialty/work
Street address
Department of Anesthesiology, Imam Reza Hospital, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3336 1994
Fax
Email
hamzeh1338@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reihan Shenasi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Unite 2, Elit apartment, Eskandari Alley, Nezami street, Vali-e-Asr Street.
City
Tabriz
Postal code
Phone
+98 41 3329 4084
Fax
Email
reihan.shenasi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)