Oxycodone hydrochloride for Patients undergoing planned surgery classified ASA physical status 1–2

Inclusion criteria

• {"criterion_text":"- Participants must be 18 years of age or above at the time of signing the informed consent.\n- Health status ASA1 or ASA2 as categorised by a medical doctor at the hospital based on medical history, physical examination, laboratory test etc. unrelated to the current study. The American Society Anesthesiologists physical status ASA1 and ASA2 (ASA1 is defined as \"Healthy, non-smoking, no or minimal alcohol use\" and ASA2 is defined as \"Mild diseases only without substantive functional limitations). Being eligible for day surgery means participants are overtly healthy as determined by clinical staff. Also inpatients classified as ASA 1 and 2 can be included.\n- The participant is considered as eligible for the use of fentanyl, morphine and oxycodone by a medical doctor at the hospital, based on an overall assessment of the psychiatric and somatic condition, used medical drugs, regarding possible interactions and contraindications for the use of the study medicaments.\n- Body weight and body mass index (BMI) within the range 18-35 kg/m2 (inclusive).\n- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n- Having good verbal communication skills in Norwegian\n- Patients undergoing planned day surgery with general anaesthesia (outpatient sample): Orthopedic, minor gastrointestinal surgery, gynecological, hand and footsurgery, and minor vascular procedures\n- Inpatients undergoing planned gynecological and orthopedic surgery: hysterectomia, laparascopic ovarectomia, lumbal herniotomy, and other related procedures. Also minor gastrointestinal surgery ."}

Exclusion criteria

• {"criterion_text":"- Known allergic reactions to morphine, oxycodone,or fentanyl.\n- Head trauma\n- Use of MAO blockers in the last two weeks\n- Hypovolemia\n- Hypotension\n- Myastenia gravis\n- Any other health status not corresponding to ASA1 or ASA2. This includes patients with severe disease burden, major psychiatric disorders that could interfere with the procedures and communication.\n- Pregnancy . Women of childbearing potential defined as all premenopausal female (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause) will be asked if they are pregnant.\n- Breastfeeding women\n- Prior or ongoing use of illicit drugs like opioids, cocaine and amphetamine.\n- Severe chronic obstructive lung disease\n- Cor pulmonale\n- Severe bronchial asthma\n- Severe respiratory failure with hypoxemia and hypercapnia\n- Moderate to severe hepatic impairment\n- Moderate to severe kidney failure,\n- Acute abdomen\n- Increased brain pressure"}

Primary endpoints

• {"endpoint_text":"- The primary endpoints will be the mean ratings for each drug as follows (rated by the participants on the operating table using a verbal numeric rating scale (NRS 0-10)).\n- Self-report items: - Numeric rating scales (0-10) on affective states ( pre-drug rating): Good, pain,relaxed,anxious\n- After IV drug administration, the patients is asked to indicate when they first feel a drug effect, and the time (seconds post-administration) is recorded along with the patient's description of this effect\n- after a standardized waiting time (2 min)the study personnel ask further questions about the patients' affective state. In the case that no effect has been indicated within the first two minutes, patients are asked if they feel an effect and if so, to describe it. The patient is then asked to report on an NRS 0-10, again how \"good\", \"anxious\", \"pain\", and \"relaxed\" they feel on a numerical rating scale NRS 0-10. We also measure acute drug effects such as \"high\", \"liking the effect\", \"disli","definition_or_measurement_approach":"Measured by participant self-report using verbal Numeric Rating Scales (NRS 0-10) on affective states (good, pain, relaxed, anxious); time-to-first-effect recorded in seconds after IV administration; standardized 2-minute post-dose assessment; acute subjective effects (e.g. \"high\", \"drug liking\") also measured by NRS or descriptive report."}

Secondary endpoints

• {"endpoint_text":"- Mean differences on the objective measures pre- and post opioid administration between the different drug groups: -HRV (heartrate variability)","definition_or_measurement_approach":"Objective physiological measures comparing pre- and post-opioid administration; specifically heart rate variability (HRV)."}
• {"endpoint_text":"- Multiple regressions will be fit to the subjective outcome measures (post-opioid) to investigate variability explained by measures at preopioid. Specifically, the predictor value of measures identified as risk factors for problematic opioid use in previous studies (e.g. prior opioid use, SUD and depression) will be assessed on the subjective items below: • Good • Pain • anxious • Relaxed • Drug high • Euphoric • Drug liking","definition_or_measurement_approach":"Statistical analysis: multiple regression models to assess how pre-opioid risk factors (e.g. prior opioid use, substance use disorder, depression) predict post-opioid subjective outcome measures (listed NRS items)."}

Norway

Earliest CTIS Part Ii Submission Date

29-10-2024

Latest Decision Or Authorization Date

14-11-2024

Processing Time Days

16

Number Of Sites

2

Number Of Participants

1000

Primary sponsor

Full Name

Vestre Viken HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway