N/A
Completed N=50
Metabolites of Tramadol in the Postoperative Surgical Patients
Abdominal Surgery · Respiratory Failure · renal failure · Liver Dysfunction
Source: ClinicalTrials.gov NCT04004481 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype — 372.7; 7.05; 17.1; 40.9 mcg/L
Summary
Tramadol is opioid analgesic widely used to treat moderate to severe pain. It is metabolized by cytochrome CYP2D6 into two major metabolites: pharmacologically active metabolite O-desmethyltramadol (M1) and inactive N-desmethyltramadol (M2), respectively. Tramadol kinetics in a population of patients undergoing major abdominal surgical procedures, and in patients with a greater or lesser degree of organic failure, is still not well researched. The investigators will measure plasma concentrations of tramadol and its metabolites after usual tramadol doses in ICU patients after major abdominal surgery. Also analgesic affect and side effect of tramadol will be recorded.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype |
372.7; 7.05; 17.1; 40.9; 13.8; 11.7 | — |
| SECONDARY Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) |
7; 5; 5; 3; 3.5; 2 | — |
| SECONDARY Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Nausea and Vomiting After Tramadol |
12; 4 | — |
| SECONDARY Number of Patients With Respiratory Depression After Tramadol |
— | — |
| SECONDARY Length of ICU Stay |
1.5; 1 | — |
Eligibility Criteria
Inclusion Criteria
- patients after major abdominal surgery will be observed.
- surgical interventions requiring a laparotomy and involving resection of the organs of the digestive system
- postoperative ICU admission.
Exclusion Criteria
- allergic reaction to tramadol
- patients under 18 years old
- patient over 90 years old
- BMI 35
- laparoscopic surgery
- chronic therapy with tramadol, cimetidine, paroxetine, pimozide, metoclopramide, amiodarone, olanzapine, chlorpromazine, fluphenazine, haloperidol, thioridazine, risperidone and clozapine
Data sourced from ClinicalTrials.gov (NCT04004481). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.