Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001295437
Ethics application status
Approved
Date submitted
1/09/2016
Date registered
14/09/2016
Date last updated
14/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of depression on anaesthetic requirement in patients undergoing laparoscopic cholecystectomy
Scientific title
Effect of major depressive disorder on anaesthetic requirement in patients undergoing laparoscopic cholecystectomy.
Secondary ID [1] 290073 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
major depressive disorder 300149 0
laparoscopic cholecystectomy 300150 0
Condition category
Condition code
Anaesthesiology 300025 300025 0 0
Anaesthetics
Mental Health 300026 300026 0 0
Depression
Oral and Gastrointestinal 300027 300027 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In all groups anesthesia was standardized and induced with propofol 2 mg/kg, muscle relaxation with rocuronium 0.5mg/kg by several anesthesiologists. Fentanyl was given to all patients intravenously as a bolus 1 mcg/kg before induction of anesthesia. Anesthesia was maintained with sevoflurane in a mixture of nitrous oxide 2L/min and oxygen 2L/min, and all patients were mechanically ventilated to maintain an ETCO2 concentration of 30-37 mmHg. The patients were divided into two groups by using the Beck Depression Inventory(BDI). BDI is a 21-item self-administered scale measuring various symptoms of depression. It comprises 21 groups of statements describing the somatic and cognitive-emotional symptoms of depression. Each item consists of four alternative responses graded from 0 to 3 according to the severity of the symptom. The patients choose the response closest to their state during the past week. A sum score is counted, a higher score indicating more severe depression. If the BDI score was under 10, it was called as control group. Patients were consulted to the psychiatrist when the BDI score was 17 or more. The psychiatric assessment was performed using the Structured Clinical Interview for DSM-IV Axis 1 disorders (SCID-I) with a trained interviewer. Patients who had axis-II disorders. psychiatric depression and seasonal affective disorder were excluded. Patients whom were diagnosed as MDD by the psychiatrist, they were classified as MDD group. Beck Anxiety Inventory(BAI) was also applied to all patients. Anesthesia was administered by blinded study raters who did not know patient’s group allocation. None of the patients were premedicated. Patients were observed during surgery.
Intervention code [1] 295805 0
Not applicable
Comparator / control treatment
Beck Depression Inventory(BDI) were asked to the
patients. BDI is a 21-item self-administered scale measuring various symptoms of depression. It comprises 21 groups of statements describing the somatic and cognitive-emotional symptoms of depression. Each item consists of four alternative responses graded from 0 to 3 according to the severity of the symptom. The patients choose the response closest to their state during the past week. A sum score is counted, a higher score indicating more severe depression. If the BDI score was under 10, it was called as control group.
Control group
Active

Outcomes
Primary outcome [1] 299510 0
anesthetic requirement is assessed by review of hospital anesthesia records.
Timepoint [1] 299510 0
from start of procedure to end of the procedure.
Secondary outcome [1] 327369 0
none
Timepoint [1] 327369 0
none

Eligibility
Key inclusion criteria
Inpatients planning to undergo laparoscopic cholecystectomy as an elective surgery
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients having urgency about cholecystitis, renal failure, thyroid dysfunction, morbid obesity, obstructive sleep apnea, neurological dysfunction, alcoholism, anticonvulsants, antidepressants and opioids usage

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
19/08/2016
Date of last data collection
Anticipated
Actual
22/08/2016
Sample size
Target
60
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 8174 0
Turkey
State/province [1] 8174 0
ISTANBUL

Funding & Sponsors
Funding source category [1] 294441 0
Self funded/Unfunded
Name [1] 294441 0
Unfunded
Country [1] 294441 0
Primary sponsor type
Individual
Name
VEYSEL ERDEN
Address
Istanbul Research and Education Hospital Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH/ ISTANBUL
Country
Turkey
Secondary sponsor category [1] 293296 0
None
Name [1] 293296 0
none
Address [1] 293296 0
none
Country [1] 293296 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295872 0
Istanbul Research and Education Hospital
Ethics committee address [1] 295872 0
Ethics committee country [1] 295872 0
Turkey
Date submitted for ethics approval [1] 295872 0
10/02/2016
Approval date [1] 295872 0
26/02/2016
Ethics approval number [1] 295872 0
235770

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68766 0
A/Prof VEYSEL ERDEN
Address 68766 0
ISTANBUL RESEARCH and EDUCATION HOSPITAL
Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH
Country 68766 0
Turkey
Phone 68766 0
+90 212 459 60 50
Fax 68766 0
Email 68766 0
[email protected]
Contact person for public queries
Name 68767 0
CIHAN GULER
Address 68767 0
ISTANBUL RESEARCH and EDUCATION HOSPITAL
Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH
Country 68767 0
Turkey
Phone 68767 0
+90 212 459 61 63
Fax 68767 0
Email 68767 0
[email protected]
Contact person for scientific queries
Name 68768 0
CIHAN GULER
Address 68768 0
ISTANBUL RESEARCH and EDUCATION HOSPITAL
Kasap Ilyas district Org.Abdurrahman Nafiz Gurman street Postal code:34098 FATIH
Country 68768 0
Turkey
Phone 68768 0
+90 212 459 61 63
Fax 68768 0
Email 68768 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBispectral-Index-measured sevoflurane requirement might be decreased in individuals with major depressive disorder.2018https://dx.doi.org/10.23736/S0375-9393.17.11713-X
N.B. These documents automatically identified may not have been verified by the study sponsor.