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Trial registered on ANZCTR
Registration number
ACTRN12618000535279
Ethics application status
Approved
Date submitted
1/02/2018
Date registered
11/04/2018
Date last updated
11/04/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Results of a Pain Monitoring (Analgesia Nociceptive Index (ANI)) In Patients Undergoing Pituitary Surgery Under General Anesthesia
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Scientific title
Results Of Analgesia Nociceptive Index (ANI) Monitoring In Patients Undergoing Pituitary Surgery Under General Anesthesia
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Secondary ID [1]
293799
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Supported by Selcuk University Scientific Research Project Coordination
ID Number: 17102008
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Universal Trial Number (UTN)
U1111-1207-8382
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
pain management
306207
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haemodynamic instability
306208
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postoperative nausea vomiting
306212
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hyperalgesia
306214
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Condition category
Condition code
Anaesthesiology
305313
305313
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0
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Anaesthetics
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Anaesthesiology
305314
305314
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0
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Pain management
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Results of intra-operative usage of analgesia nociceptive index (ANI) in patients undergoing pituitary surgery under general anaesthesia
Duration of observation: Intraoperative and postoperative period till discharge
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Intervention code [1]
300052
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Early Detection / Screening
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Comparator / control treatment
No treatment
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Control group
Active
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Outcomes
Primary outcome [1]
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Intraoperative amount of remifentanil consumption. This outcome will be assessed by calculating the mean remifentanil infusion rate by perfusor for each patient.
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Assessment method [1]
304622
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Timepoint [1]
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During intraoperative period, starting with remifentanil infusion after anesthesia induction and ending with termination of anesthesia in every 5 minutes
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Secondary outcome [1]
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Hemodynamic stability as assessed by invasive arterial blood pressure monitoring
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Assessment method [1]
342597
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Timepoint [1]
342597
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During intraoperative period, starting before anesthesia induction and ending with discharge from PACU in every 5 minutes
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Secondary outcome [2]
342598
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Postoperative pain assessment via numeric rating scale (NRS)
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Assessment method [2]
342598
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Timepoint [2]
342598
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At postoperative 1th, 2nd, 6th, 12th, 24th hours
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Secondary outcome [3]
342599
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Postoperative nausea-vomiting via The Postoperative Nausea And Vomiting Intensity Scale
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Assessment method [3]
342599
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Timepoint [3]
342599
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Start after PACU admission and repeated at 24th hour in the ward
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Eligibility
Key inclusion criteria
18-65 years, ASA I-III adult patients undergoing elective trans-sphenoidal hypophysectomy under general anesthesia
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with known systemic diseases such as diabetes mellitus, uncontrolled hypertension, cardiac disease, autonomic dysfunction, psychiatric disease and pregnants.
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Study design
Purpose
Screening
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Descriptive analyses were presented using mean ± standard deviation (Min-Max) for the continuous variables and using frequencies and percentage for the categorical variables. The variables were investigated using Kolmogorov-Smirnov test to determine whether or not they are normally distributed. Student-t test was conducted to compare two normally distributed groups and Mann-Whitney-U test was conducted to compare two non-normally distributed groups. The distribution of categorical data among the groups was analyzed by Pearson’s Chi-square test. The sphericity assumption was assessed using Mauchly’s Test, which tests the hypothesis that the variances of the differences between conditions are equal.
Therefore, if the sphericity assumption was met, repeated-measures ANOVA was used to compare the within-group averages. If not, Multivariate ANOVA (MANOVA) was used to compare the within-group averages. Bonferroni correction was used as a multiple comparison test. Statistically significant level of p <0.05 was accepted.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
30/03/2017
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Date of last participant enrolment
Anticipated
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Actual
27/10/2017
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Date of last data collection
Anticipated
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Actual
30/10/2017
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Sample size
Target
40
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Accrual to date
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Final
40
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Recruitment outside Australia
Country [1]
9540
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Turkey
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State/province [1]
9540
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Funding & Sponsors
Funding source category [1]
298416
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University
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Name [1]
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Selcuk University Scientific Research Project Coordination
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Address [1]
298416
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Selcuk University Alaadin Keykubat Campus Akademi Mah. Yeni Istanbul Street No:313
Selcuklu KONYA
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Country [1]
298416
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Turkey
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Primary sponsor type
University
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Name
Selcuk University Scientific Research Project Coordination
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Address
Selcuk University Alaadin Keykubat Campus Akademi Mah. Yeni Istanbul Street No:313
Selcuklu KONYA
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Country
Turkey
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Secondary sponsor category [1]
297553
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Hospital
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Name [1]
297553
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Selcuk University Faculty Of Medicine Hospiatl
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Address [1]
297553
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Selcuk University Alaadin Keykubat Campus Akademi Mah. Yeni Istanbul Street No:313
Selcuklu KONYA
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Country [1]
297553
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Turkey
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299412
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Selcuk University Local Ethics Committee
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Ethics committee address [1]
299412
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Selcuk University Faculty of Medicine Alaadin Keykubat Campus Akademi Mah. Yeni Istanbul Street No:313 Selcuklu KONYA
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Ethics committee country [1]
299412
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Turkey
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Date submitted for ethics approval [1]
299412
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17/02/2017
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Approval date [1]
299412
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22/02/2017
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Ethics approval number [1]
299412
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2017-76
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Summary
Brief summary
High dose opioid usage causes intraoperative and postoperative complications. Measuring the perioperative analgesia sufficiency and individual titration of opioids may help to decrease the complications. ANI (analgesia nociception index) technology is used for this purpose. This technology calculates parasympathetic reflex loop and shows nociceptive/antinociceptive balance. The ANI is represented as an index on a scale between 0-100 and this index reflex the parasympathetic nervous system activity and relatively intraoperative analgesia sufficiency. Aim of this study is searching the efficacy of ANI monitorisation intraoperatively in the patients undergoing transsphenoidal pituitary surgery under general anesthesia.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Oguzhan ARUN
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Address
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Selcuk University Faculty of Medicine Department of Anesthesiology and Reanimation
Akademi Mah. Yeni Istanbul Street No:313 Alaaddin Keykubat Yerleskesi 42130 Selcuklu Konya TURKEY
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Country
80314
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Turkey
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Phone
80314
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+905326686993
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Fax
80314
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Email
80314
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[email protected]
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Contact person for public queries
Name
80315
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Serdal Bozdogan
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Address
80315
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Selcuk University Faculty of Medicine Department of Anesthesiology and Reanimation
Akademi Mah. Yeni Istanbul Street No:313 Alaaddin Keykubat Yerleskesi 42130 Selcuklu Konya TURKEY
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Country
80315
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Turkey
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Phone
80315
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+905305278955
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Fax
80315
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Email
80315
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[email protected]
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Contact person for scientific queries
Name
80316
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Oguzhan ARUN
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Address
80316
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Selcuk University Faculty of Medicine Department of Anesthesiology and Reanimation
Akademi Mah. Yeni Istanbul Street No:313 Alaaddin Keykubat Yerleskesi 42130 Selcuklu Konya TURKEY
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Country
80316
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Turkey
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Phone
80316
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+905326686993
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Fax
80316
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Email
80316
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[email protected]
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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
No additional documents have been identified.
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