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CompletedNot applicable

Opioid-based Versus Opioid-free Endotracheal Intubation

NCT06464393 · Aretaieion University Hospital

Closed to entry
Status
Not accepting participants
Not applicable
Phase
70
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The aim of this study will be to investigate the effect of opioid-free induction versus opioid-based induction on hemodynamic response and nociception level index during elective operations

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • change from baseline in systolic arterial pressure after premedication

    Measured over 30 seconds after premedication

  • change from baseline in systolic arterial pressure immediately after premedication

    Measured over immediately after intubation

  • change from baseline in systolic arterial pressure 1 minute after intubation

    Measured over 1 minute after intubation

  • change from baseline in systolic arterial pressure 3 minutes after intubation

    Measured over 3 minutes after intubation

  • change from baseline in systolic arterial pressure 5 minutes after intubation

    Measured over 5 minutes after intubation

  • change from baseline in diastolic arterial pressure after premedication

    Measured over 30 seconds after premedication

  • change from baseline in diastolic arterial pressure 1 minute after intubation

    Measured over 1 minute after intubation

  • change from baseline in diastolic arterial pressure 3 minutes after intubation

    Measured over 3 minutes after intubation

  • change from baseline in diastolic arterial pressure 5 minutes after intubation

    Measured over 5 minutes after intubation

  • change from baseline in heart rate after premedication

    Measured over 30 seconds after premedication

  • change from baseline in heart rate 1 minute after intubation

    Measured over 1 minute after intubation

  • change from baseline in heart rate 3 minutes after intubation

    Measured over 3 minutes after intubation

  • change from baseline in heart rate 5 minutes after intubation

    Measured over 5 minutes after intubation

  • ST segment change 1 minute post intubation

    Measured over 1 minute after intubation

  • ST segment change 3 minutes post intubation

    Measured over 3 minutes after intubation

  • ST segment change 5 minutes post intubation

    Measured over 5 minutes after intubation

  • duration of nociception level<25 for a 5-minute period after intubation

    Measured over 5 minutes after intubation

  • time required to achieve a train-of four-ratio of 0

    Measured over within 2.5 minutes of neuromuscular blocking agent administration

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 80 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * adult patients * American Society of Anesthesiologists (ASA) classification I-II * Mallampati classification 1, 2 or 3 Exclusion Criteria: * anticipated difficult airway (Mallampati 4 classification, thyromental distance \< 6 cm, mouth opening \< 3 cm, neck extension\< 80 * atrioventricular block * bradycardia (heart rate less than 55/min) * preadministration of beta-blockers * eligibility for rapid-sequence induction * chronic use of opioid medications * known allergy to induction agents * history of psychiatric disease * language or communication barriers or lack of informed consent

Where

1 study site

FacilityCityRegionCountry
Aretaieion University HospitalAthensGreece

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06464393 on ClinicalTrials.gov →

Last updated in the registry 2025-07-22. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits