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Completed

NCT Number: NCT03425084

Genetic Variation in Organic Cation Transport 1 (OCT1) and Its Significance for Morphine Pharmacokinetics

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

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Key information

Conditions

Organic Cation Transporter 1 Morphine

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sydvestjysk Sygehus, Esbjerg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine

Drug

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

Primary outcomes

  1. Morphine Area under the curve (AUC)

    Time frame: 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 outcomes

  1. Morphine effect

    Time frame: 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.

  2. Morphine effect

    Time frame: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus

    side effects will be evaluated through a 5-point verbal questionnaire on the same patients where 0 is no side effects and 4 is unacceptable side effects.

  3. Morphine effect

    Time frame: Questionnaire answers will be collected with an appropriate time interval for 24 hours after the first morphine bolus

    The degree of sedation will be evaluated through the Richmond Agitation and Sedation Scale (RASS) on the same patients

  4. Morphine effect

    Time frame: After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.

    The total dose of morphine used during the investigation.

  5. Morphine effect

    Time frame: After the trial has ended (24 hours after the first morphine bolus) data containing morphine use will be collected.

    The number of administrations of morphine will be recorded

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Danish Council for Independent Research
  • Region of Southern Denmark
  • The Faculty of Health Sciences SDU

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2018
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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