Skip to content

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

Determination of Patients' Visual Analogue Scale (VAS) in Postoperative Patients Receiving Tramadol Analgesia in the Minangkabau Ethnic Group, Indonesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06642480
Acronym
Tramadol
Enrollment
63
Registered
2024-10-15
Start date
2022-01-01
Completion date
2023-03-01
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Analgesia, Tramadol

Keywords

Tramadol, Post Operative, Minangkabau

Brief summary

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.

Detailed 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).

Interventions

DRUGPost Operative Analgesia

administering 100 mg of intravenous tramadol 30 minutes before the operation is completed

Sponsors

Andalas University
CollaboratorOTHER
Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model 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).

Eligibility

Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No

Inclusion criteria

* Post operative patients who get analgesic tramadol

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Determination of Patients' Visual Analogue Scale (VAS). It was observed in the recovery room at 30, 60, and 120 minutesPain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026