Correlation of genetic variations with use of remifentanil as the analgesic during elective thyroid gland surgery

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001598471
• Date of registration: 18/11/2016
• Prospective Registration: Yes
• Primary sponsor: Aristotle University of Thessaloniki, Greece
• 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
• Date of first enrolment: 01/03/2017
• Target sample size: 180
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001598471.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Greece

Contacts

• Name: Dr Antonios Goulas

• Name: Dr Ioanna Soultati

Key inclusion & exclusion criteria

Inclusion criteria: Patients aged 18-79 years,
Preoperative ASA 1-2,
Normal levels of thyroid hormones
Elective thyroidectomy operation
Informed consent for enrollment given
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.

Age minimum: 18 Years
Age maximum: 79 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

thyroidectomy;
thyroidectomy

Anaesthesiology - Pain management

Intervention(s)

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

Primary Outcome(s)

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[One hour after the patients will recover from anesthesia]

Secondary Outcome(s)

Correlation of requirements in remifentanil with the preoperative score in the Hamilton anxiety scale rating.[End of surgery]

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.[End of surgery
1 hour postoperatively
Six hours postoperatively]

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.[End of surgery
1 hour postoperatively
Six hours postoperatively]

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.[End of surgery
1 hour postoperatively
Six hours postoperatively]

Secondary ID(s)

NONE

Source(s) of Monetary Support

Aristotle University of Thessaloniki, Greece

Ethics review

Status: Approved
Approval date:
Contact:

Bioethics Committee of Medical School. Aristotle Univeristy of Thessaloniki, Greece

Status: Approved
Approval date:
Contact:

Scientific Committee of General University Hospital of Thessaloniki, AHEPA

Results

• Results available: Yes
• Date Posted: 09/12/2019
• Date Completed: 04/12/2019