Distribution of CYP2D6 Multiplication, CYP2D6*5, and Clinical Implications in Postoperative Patients Receiving Tramadol Analgesia in the Minangkabau Ethnic Group, Indonesia

National Research and Innovation Agency (BRIN)

Status: Completed

Conditions: Post Operative Analgesia; Tramadol

Treatments: Drug: Post Operative Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06642480

BRIN

2/III/HK/2022 (Other Grant/Funding Number)

Details and patient eligibility

About

Cytochrome P450 2D6 (CYP2D6) is an important enzyme in metabolizing commonly used drugs such as Tramadol hydrochloride (widely used opioid analgesic). Genetic polymorphisms of the CYP2D6 gene have been shown to influence the pharmacodynamic properties of the administered drug. This study aimed to screen 63 postoperative patients (wild-type, CYP2D6*5, and CYP2D6 multiplication) of Minangkabau ethnicity in West Sumatera, Indonesia, who received tramadol using a modified long PCR method and to investigate the clinical impact of tramadol on the patients.

Full description

VAS of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. It was observed in the recovery room at 30, 60, and 120 minutes. Tramadol had an onset time of 15-60 minutes, with peak effectiveness at 2-6 hours postoperatively. Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).

Enrollment: 63 patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Post operative patients who get analgesic tramadol

Exclusion criteria

• No exclusion criteria

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Determination of Patients' Visual Analogue Scale (VAS)

Other group

Description:

Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).

Treatment:

Drug: Post Operative Analgesia

Drug: Post Operative Analgesia