Evaluation of Opioid-Free Multimodal Anesthesia on Functional Neuroimaging and Electroencephalogram in Healthy Volunteers Undergoing Induced Sedation

The primary objective of the study is to evaluate the effects of **opioid-free multimodal anesthesia** on functional neuroimaging and electroencephalogram in **healthy volunteers undergoing induced sedation**. This investigation is clinically relevant as it aims to understand the impact of avoiding opioids in anesthesia, which could potentially reduce opioid-related side effects and improve patient outcomes during sedation. The study does not specify any secondary objectives.

The clinical trial involves **healthy volunteers** undergoing induced sedation. The study population includes both male and female participants, with an age range classified under category code 3, which typically corresponds to adults. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their general health status as healthy individuals, without specific lifestyle considerations such as diet or physical activity being highlighted. Key inclusion or exclusion criteria have not been specified by the sponsor.

The clinical trial is designed to evaluate the effects of **opioid-free multimodal anesthesia** on functional neuroimaging and electroencephalogram in **healthy volunteers undergoing induced sedation**. This study is a Phase 3 trial, employing a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The trial is expected to commence recruitment on May 6, 2025, and conclude by April 6, 2027, with an overall duration of approximately two years.

Participants will undergo a series of study visits, beginning with an inclusion visit, which serves as the screening phase to assess eligibility based on predefined criteria. Following successful inclusion, participants will be randomly assigned to either the intervention or control group. Throughout the trial, follow-up visits will be scheduled at regular intervals to monitor the participants' response to the anesthesia and collect data on neuroimaging and electroencephalogram outcomes. The end-of-study visit will mark the completion of the trial for each participant, during which final assessments will be conducted to evaluate the primary and secondary endpoints.

The expected length of participant involvement will vary depending on the specific protocol requirements, but it is anticipated to span several months. Conditions that may lead to early termination from the study include adverse events, withdrawal of consent, or non-compliance with the study protocol. The trial is structured to maintain the highest ethical standards and ensure participant safety throughout the study duration.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments or their administration protocols. Information regarding the monitoring of participant compliance with the dosing schedules is also not available in the provided data.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on May 6, 2025, with an estimated completion date of April 6, 2027. The efficacy of the investigational treatment will be evaluated through predefined primary and secondary endpoints, although specific endpoints are not detailed in the provided data. The trial will follow a structured methodology to ensure the accurate collection and analysis of efficacy data, adhering to the standards expected in a Phase 3 clinical trial. The trial's design and execution will be aligned with regulatory requirements to ensure the reliability and validity of the efficacy assessments.