Clinical trial NCT06814652: The Impact of CYP2D6 Polymorphism on Tramadol Pharmacodynamics
Official title: The Outcome of CYP2D6 Polymorphism on Tramadol Analgesia in Postpartum Patients in Erbil
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Post-cesarean Pain
CYP2D6 Polymorphism
Tramadol Resistance
Lead sponsor: Elweyia Maternity Teaching Hospital
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patients who were indicated for elective cesarean section surgery at public hospital (Maternity Teaching hospital) located in Erbil city, Iraq were enrolled.

Brief summary: CYP2D6 is an enzyme involved in the hepatic metabolism of many clinically important drugs: antiarrhythmics, antidepressants, antipsychotics, β-blockers, and analgesics such as tramadol and codeine. CYP2D6 is highly polymorphic and significant interindividual variability has been observed worldwide. This study aims to investigate the distribution of CYP2D6 polymorphisms among post-cesarean female patients in Erbil city, Iraq. The findings of this study may indicate the presence of CYP2D6 gene variants among the Kurdish female population in Erbil, which could contribute to tramadol analgesic failure or exaggerated adverse effects. This study could also serve as a foundation for further pharmacogenetic research, individualizing treatments and targeting a larger sample size in the future.


Eligibility criteria: Inclusion Criteria:

* Female patients aged between 18-56 years old
* Patients who undergo cesarean section surgery
* Patients receive tramadol drug for postpartum pain management

Exclusion Criteria:

* Patients with any history of severe renal, liver, respiratory diseases and/or seizures
* Patients with history of psychiatric disorders or unable to provide consent
* Patients with complicated surgeries or neonatal distress or unable to perform the clinical assessment of pain
* Patients with history of consumption of chronic alcohol or opioid or drug abuse
* Patients with history of known allergy to tramadol

Primary outcomes:
measure: Visual analog scale (10 cm)
timeFrame: after 1 hour and 6 hours of receiving single dose of tramadol
Secondary outcomes:
measure: Blood pressure (mm of Hg)
timeFrame: after 1 hour and 6 hours of receiving single dose of tramadol
measure: Heart rate (beats per minute)
timeFrame: after 1 hour and 6 hours of receiving single dose of tramadol
measure: Oxygen saturation (SPO2%)
timeFrame: after 1 hour and 6 hours of receiving single dose of tramadol
measure: Nocturnal pain
timeFrame: after 24 hours of receiving single dose of tramadol
measure: Dietary state
timeFrame: after 24 hours of receiving single dose of tramadol
measure: Adverse effects
timeFrame: after 1 hour and 6 hours of receiving single dose of tramadol for recording any adverse effects, and after 24 hours of receiving single dose of tramadol for evaluation of the bowel movement (whether the patient was constipated).
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medical University/ College of Medicine
Study officials:
References: