Comparing opioid-based and opioid-free methods for intubation
The Effect of Opioid-free Anesthesia on Hemodynamic Response and Nociception Level Index During Laryngoscopy and Intubation
This study is testing whether using an opioid-free method for intubation can lead to better health responses during surgery compared to the traditional opioid-based approach.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Aretaieion University Hospital Academic / other |
| Locations | 1 site (Athens) |
| Trial ID | NCT06464393 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of opioid-based versus opioid-free induction on hemodynamic responses and nociception levels during elective surgeries. It aims to compare the hemodynamic response to laryngoscopy and intubation between two groups: one receiving opioid medications and the other receiving a combination of lidocaine, dexmedetomidine, and ketamine. The research addresses the common practice of using opioids to mitigate sympathetic responses during intubation, while also considering the side effects associated with opioid use. The goal is to evaluate the potential benefits of an opioid-free approach in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adult patients classified as ASA I-II with Mallampati classifications of 1, 2, or 3.
Not a fit: Patients with anticipated difficult airways, chronic opioid use, or certain cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer intubation practices with fewer opioid-related side effects for patients.
How similar studies have performed: Previous studies have shown promising results for opioid-free techniques in improving postoperative recovery, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Athens
- Aretaieion University Hospital — Athens, Greece (Recruiting)
Study contacts
- Principal investigator: KASSIANI THEODORAKI, PhD, DESA — Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece
- Study coordinator: Kassiani Theodoraki, PhD, DESA
- Email: ktheodoraki@hotmail.com
- Phone: +306974634162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.