Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001598471
Ethics application status
Approved
Date submitted
24/10/2016
Date registered
18/11/2016
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Correlation of genetic variations with use of remifentanil as the analgesic during elective thyroid gland surgery
Scientific title
Correlation study of SLC01A2 and ABCB1 gene polymorphisms and perioperative remifentanil requirements in patients undergoing elective thyroidectomy
Secondary ID [1] 290352 0
NONE
Universal Trial Number (UTN)
U1111-1188-8195
Trial acronym
PERRETT

PErioperative Remifentanyl REquiremenT Thyroidectomy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
thyroidectomy 300641 0
Condition category
Condition code
Anaesthesiology 300486 300486 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Preoperative assesment of anxiety using the Hamilton anxiety scale rating.
Administration of intravenous Remifentanil with Target- Controlled-Infusion technique (TCI) in patients undergoing elective thyroidectomy
Remifentanil will be the exclusive opioid analgesic given during the whole anesthetic and surgical procedure
Remifentanil serum target levels will range between 1-2.5 ng/ml
The approximate duration of surgery will be 60-90 minutes.
Indentification of polymorphism of genes SLC01A2 and ABCB1
Correlation of gene polymorphisms with remifentanil requirements as well as its efficacy and safety
Intervention code [1] 296168 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299915 0
Correlation of the total requirements for remifentanil (n/kg/h) (assessed using TCI infusion pump indications and the total duration of the surgery) with SLC01A2 and ABCB1 gene polymorphisms (assessed by serum assay).
Remifentanil total requirements will be assessed using the TCI infusion pump indications and the total duration of the surgery
Timepoint [1] 299915 0
One hour after the patients will recover from anesthesia
Secondary outcome [1] 328513 0
Correlation of gene polymorphisms with the subjective sensation of pain.
For the assessment of postoperative pain the visual analogue scale (VAS) score will be used.
Timepoint [1] 328513 0
End of surgery
1 hour postoperatively
Six hours postoperatively
Secondary outcome [2] 328835 0
Correlation of the subjective sensation of pain with the preoperative score in the Hamilton anxiety scale rating.
For the assessment of postoperative pain the visual analogue scale (VAS) score will be used.
Timepoint [2] 328835 0
End of surgery
1 hour postoperatively
Six hours postoperatively
Secondary outcome [3] 329194 0
Correlation of gene polymorphisms with the postoperative consumption of non steroidal anti-inflammatory analgesic drugs.
If patients need postoperative analgesia they will be treated fistly with 1000mg paracetamol (i.v.). and if the pain remains with 40mg parecoxib (i.v.).
The consumption of 1000mg paracetamol and 40mg parecoxib will be recorded.
Timepoint [3] 329194 0
End of surgery
1 hour postoperatively
Six hours postoperatively
Secondary outcome [4] 329195 0
Correlation of requirements in remifentanil with the preoperative score in the Hamilton anxiety scale rating.
Timepoint [4] 329195 0
End of surgery

Eligibility
Key inclusion criteria
Patients aged 18-79 years,
Preoperative ASA 1-2,
Normal levels of thyroid hormones
Elective thyroidectomy operation
Informed consent for enrollment given
Minimum age
18 Years
Maximum age
79 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients aged <18 and> 80 years, ranking in ASA> 3, with a history of chronic pain and / or systemic use of analgesics drugs before surgery, surgical operation non elective (emergency), severe disruption of thyroid hormone levels, pregnancy, neuropsychiatric disorders.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Control of the distribution of continuous variables with the Shapiro-Wilks test. Correlation of remifentanil requirements and postoperative subjective pain sensation with their gene polymorphisms with univariate linear ANCOVA analysis and covariates demographics and preoperative anxiety levels. Correlation of intraoperative hemodynamic change data by ANOVA Repeated measurements.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2016
Actual
1/03/2017
Date of last participant enrolment
Anticipated
30/11/2019
Actual
3/12/2019
Date of last data collection
Anticipated
31/12/2019
Actual
4/12/2019
Sample size
Target
180
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 8344 0
Greece
State/province [1] 8344 0
Thessaloniki, Macedonia

Funding & Sponsors
Funding source category [1] 294773 0
University
Name [1] 294773 0
Aristotle University of Thessaloniki, Greece
Country [1] 294773 0
Greece
Primary sponsor type
University
Name
Aristotle University of Thessaloniki, Greece
Address
Aristotle University of Thessaloniki, University Campus, 54124, Thessaloniki, Greece
Country
Greece
Secondary sponsor category [1] 293619 0
None
Name [1] 293619 0
Address [1] 293619 0
Country [1] 293619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296179 0
Scientific Committee of General University Hospital of Thessaloniki, AHEPA
Ethics committee address [1] 296179 0
Ethics committee country [1] 296179 0
Greece
Date submitted for ethics approval [1] 296179 0
26/04/2016
Approval date [1] 296179 0
20/05/2016
Ethics approval number [1] 296179 0
322
Ethics committee name [2] 296180 0
Bioethics Committee of Medical School. Aristotle Univeristy of Thessaloniki, Greece
Ethics committee address [2] 296180 0
Ethics committee country [2] 296180 0
Greece
Date submitted for ethics approval [2] 296180 0
09/05/2016
Approval date [2] 296180 0
06/07/2016
Ethics approval number [2] 296180 0
319

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1198 1198 0 0
/AnzctrAttachments/371680-Bioethics Committee.pdf (Ethics approval)
Attachments [2] 1199 1199 0 0
/AnzctrAttachments/371680-Scientific Committee of AHEPA General Hospital.pdf (Ethics approval)

Contacts
Principal investigator
Name 69778 0
Dr Chryssa Pourzitaki
Address 69778 0
2nd Department of Pharmacology, Faculty of Medicine, School of Health Sciences, University Campus, Aristotle University of Thessaloniki, 54124, Greece
Country 69778 0
Greece
Phone 69778 0
+302310999025
Fax 69778 0
+302310999312
Email 69778 0
[email protected]
Contact person for public queries
Name 69779 0
Ioanna Soultati
Address 69779 0
Clinic of Anesthesiology and Intensive Care, AHEPA University Hospital, Faculty of Medicine, School of Health Sciences, Stilponos Kyriakidi 1, Aristotle University of Thessaloniki, 54124, Greece
Country 69779 0
Greece
Phone 69779 0
+302313303267
Fax 69779 0
Email 69779 0
[email protected]
Contact person for scientific queries
Name 69780 0
Antonios Goulas
Address 69780 0
1st Department of Pharmacology, Faculty of Medicine, School of Health Sciences, University Campus, Aristotle University of Thessaloniki, 54124, Greece
Country 69780 0
Greece
Phone 69780 0
+302310999312
Fax 69780 0
+302310999312
Email 69780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
They will be shared after requirement


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.