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

NCT06642480 | Completed

• 2 other identifiers: BRIN2/III/HK/2022
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Analgesia; Tramadol

Keywords

Tramadol; Post Operative; Minangkabau

Outcome Measures

Primary Outcomes (1)

• Determination of Patients' Visual Analogue Scale (VAS)

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

  . It was observed in the recovery room at 30, 60, and 120 minutes

Study Arms (1)

Determination of Patients' Visual Analogue Scale (VAS)

OTHER

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

Drug: Post Operative Analgesia

Interventions

Post Operative Analgesia DRUG

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

Determination of Patients' Visual Analogue Scale (VAS)

Eligibility Criteria

• Age: Up to 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Post operative patients who get analgesic tramadol

Sponsors & Collaborators

• Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia: lead
• Andalas University: collaborator

Study Sites (1)

Rsup Dr M Djamil Padang

Padang, West Sumatra, 25129, Indonesia

Location

Related Publications (1)

• Effendi R, Rizqia Haz A, Muhammad Fuad A, Dermawan B, Utami N, Desriani. Distribution of CYP2D6 multiplication, CYP2D6*5, and clinical implications in postoperative patients receiving tramadol analgesia in the Minangkabau ethnic group, Indonesia. F1000Res. 2025 Sep 23;13:1526. doi: 10.12688/f1000research.155988.3. eCollection 2024.

  PMID: 41078883 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Model Details: 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).

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)