Trial Review

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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
Scientific title
Results Of Analgesia Nociceptive Index (ANI) Monitoring In Patients Undergoing Pituitary Surgery Under General Anesthesia
Secondary ID [1] 293799 0
Supported by Selcuk University Scientific Research Project Coordination
ID Number: 17102008
Universal Trial Number (UTN)
U1111-1207-8382
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain management 306207 0
haemodynamic instability 306208 0
postoperative nausea vomiting
 306212 0
hyperalgesia 306214 0
Condition category
Condition code
Anaesthesiology 305313 305313 0 0
Anaesthetics
Anaesthesiology 305314 305314 0 0
Pain management

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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
Intervention code [1] 300052 0
Early Detection / Screening
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 304622 0
Intraoperative amount of remifentanil consumption. This outcome will be assessed by calculating the mean remifentanil infusion rate by perfusor for each patient.
Timepoint [1] 304622 0
During intraoperative period, starting with remifentanil infusion after anesthesia induction and ending with termination of anesthesia in every 5 minutes
Secondary outcome [1] 342597 0
Hemodynamic stability as assessed by invasive arterial blood pressure monitoring
Timepoint [1] 342597 0
During intraoperative period, starting before anesthesia induction and ending with discharge from PACU in every 5 minutes
Secondary outcome [2] 342598 0
Postoperative pain assessment via numeric rating scale (NRS)
Timepoint [2] 342598 0
At postoperative 1th, 2nd, 6th, 12th, 24th hours
Secondary outcome [3] 342599 0
Postoperative nausea-vomiting via The Postoperative Nausea And Vomiting Intensity Scale
Timepoint [3] 342599 0
Start after PACU admission and repeated at 24th hour in the ward

Eligibility
Key inclusion criteria
18-65 years, ASA I-III adult patients undergoing elective trans-sphenoidal hypophysectomy under general anesthesia
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with known systemic diseases such as diabetes mellitus, uncontrolled hypertension, cardiac disease, autonomic dysfunction, psychiatric disease and pregnants.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/03/2017
Date of last participant enrolment
Anticipated
Actual
27/10/2017
Date of last data collection
Anticipated
Actual
30/10/2017
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 9540 0
Turkey
State/province [1] 9540 0

Funding & Sponsors
Funding source category [1] 298416 0
University
Name [1] 298416 0
Selcuk University Scientific Research Project Coordination
Country [1] 298416 0
Turkey
Primary sponsor type
University
Name
Selcuk University Scientific Research Project Coordination
Address
Selcuk University Alaadin Keykubat Campus Akademi Mah. Yeni Istanbul Street No:313
Selcuklu KONYA
Country
Turkey
Secondary sponsor category [1] 297553 0
Hospital
Name [1] 297553 0
Selcuk University Faculty Of Medicine Hospiatl
Address [1] 297553 0
Selcuk University Alaadin Keykubat Campus Akademi Mah. Yeni Istanbul Street No:313
Selcuklu KONYA
Country [1] 297553 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299412 0
Selcuk University Local Ethics Committee
Ethics committee address [1] 299412 0
Selcuk University Faculty of Medicine Alaadin Keykubat Campus Akademi Mah. Yeni Istanbul Street No:313
Selcuklu KONYA
Ethics committee country [1] 299412 0
Turkey
Date submitted for ethics approval [1] 299412 0
17/02/2017
Approval date [1] 299412 0
22/02/2017
Ethics approval number [1] 299412 0
2017-76

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80314 0
A/Prof Oguzhan ARUN
Address 80314 0
Selcuk University Faculty of Medicine Department of Anesthesiology and Reanimation
Akademi Mah. Yeni Istanbul Street No:313 Alaaddin Keykubat Yerleskesi 42130 Selcuklu Konya TURKEY
Country 80314 0
Turkey
Phone 80314 0
+905326686993
Fax 80314 0
Email 80314 0
[email protected]
Contact person for public queries
Name 80315 0
Serdal Bozdogan
Address 80315 0
Selcuk University Faculty of Medicine Department of Anesthesiology and Reanimation
Akademi Mah. Yeni Istanbul Street No:313 Alaaddin Keykubat Yerleskesi 42130 Selcuklu Konya TURKEY
Country 80315 0
Turkey
Phone 80315 0
+905305278955
Fax 80315 0
Email 80315 0
[email protected]
Contact person for scientific queries
Name 80316 0
Oguzhan ARUN
Address 80316 0
Selcuk University Faculty of Medicine Department of Anesthesiology and Reanimation
Akademi Mah. Yeni Istanbul Street No:313 Alaaddin Keykubat Yerleskesi 42130 Selcuklu Konya TURKEY
Country 80316 0
Turkey
Phone 80316 0
+905326686993
Fax 80316 0
Email 80316 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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