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

October 22, 2024 updated by: Desriani Desriani, Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Sumatera Barat
      • Padang, Sumatera Barat, Indonesia, 25129
        • Rsup Dr M Djamil Padang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Post operative patients who get analgesic tramadol

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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).
Drug: Post Operative Analgesia
administering 100 mg of intravenous tramadol 30 minutes before the operation is completed
Drug: Post Operative Analgesia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of Patients' Visual Analogue Scale (VAS)
Time Frame: . It was observed in the recovery room at 30, 60, and 120 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia

Collaborators

Andalas University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRIN
  • 2/III/HK/2022 (Other Grant/Funding Number: BRIN)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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