Morphine, Organic Cation Transporter 1
Conditions
Brief summary
The main objective of the trial is to investigate the effect of known genetic variants in organic cation transporter 1 (OCT1) on the effect of morphine after major surgery
Detailed description
The purpose of the experiment is to investigate the effect of known genetic variants in organic cation transporter 1 (OCT1) on the effect of morphine after major surgery. This is primarily done by investigating systemic exposure of morphine in a cohort of patients undergoing scheduled laparoscopic colon or laparoscopic rectum surgery, and as pain treatment with intravenous (iv) morphine at the end of and after surgery (primary endpoints). As a secondary endpoint, we will investigate the effect (pharmacodynamics) of morphine in the same patients by registering pain during rest and activity, side effects and the degree of sedation at appropriate time intervals.
Interventions
DRUGMorphine
The study was designed as an open, non-controlled drug trial, with scientists and participants blinded to the patients OCT1 status. Morphine will be given as a single dosis (0,15 mg/kg) at the end of the Surgery and later as boluses of 0,04mg/kg administrated by patient-controlled analgesia, (PCA). Blood samples with drug concentrations will be used to determine a difference in morphine AUC due to the patients OCT1 status. Questionnaire answers will be used to determine the effect of morphine due to the patients OCT1 status
Sponsors
Danish Council for Independent Research
The Faculty of Health Sciences SDU
Region of Southern Denmark
University of Southern Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Planned Colectomy / Hemicolectomy, sigmoid resection, rectal resection or abdominal perianal amputation of the rectum with stoma, good general health (ASA 1 -2), Informed consent given, Age 18-90 years and BMI 18,5 - 35kg/m².
Exclusion criteria
* Abdominoperineal resection (APR) - ad modum Holm (abdominal perianal amputation of rectum with stoma) * Daily use of opioids * Indicator for the use of an epidural catheter * Alcohol abuse * Hypersensitivity for morphine * A known serious disease (Terminal cancer, severe dementia, significant heart, liver, lung or renal failure or severe psychiatric disease) * Women of childbearing age who do not use safe contraception * Women who are breastfeeding * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Area under the curve (AUC) | Blood samples will be drawn at zero, five, 10, 15, 30, 45, 60 and 90 minutes after the first morphine bolus | Difference in morphine AUC due to patient OCT1 status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine effect | Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus | Pain during rest and activity will be evaluated through a Numeric Rating Scale on the same patients where 0 is no pain and 10 is the the worst possible pain. |
Countries
Denmark
Outcome results
None listed