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Affective effects of pre-surgery opioids (AFFECT2): a randomized, doubleblind placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518308-37-00
Enrollment
1000
Registered
2024-11-14
Start date
2022-12-13
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

but also inpatients undergoing surgery who are ASA 1 and 2., Health status ASA1 or ASA2 as categorised by a medical doctor at the hospital based on medical history and physical examination. The American Society of Anesthesiologists physical status (ASA1: "Healthy, non-smoking, no or minimal alcohol use" and ASA 2: "Mild diseases only without substantive functional limitations). Being eligible for day surgery means participants are overtly healthy as determined by clinical staff

Brief summary

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))., Self-report items: - Numeric rating scales (0-10) on affective states ( pre-drug rating): Good, pain,relaxed,anxious, 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, 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

Detailed description

Mean differences on the objective measures pre- and post opioid administration between the different drug groups: -HRV (heartrate variability), 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

Interventions

DRUGOXYCODONE
DRUGMORPHINE
DRUGFENTANYL
DRUGNaCl

Sponsors

Vestre Viken HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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))., Self-report items: - Numeric rating scales (0-10) on affective states ( pre-drug rating): Good, pain,relaxed,anxious, 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, 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", "dis

Secondary

MeasureTime frame
Mean differences on the objective measures pre- and post opioid administration between the different drug groups: -HRV (heartrate variability), 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

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026