Inhalational Agents Versus Dexmedetomidine for Maintenance of General Anesthesia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age39-99
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital

About this trial

The climate crisis and environmental pollution are escalating day by day, making the reduction of carbon footprints increasingly important both on an individual and industrial level. Inhalational anesthetic agents are widely used in daily anesthesia practice. However, some of these agents are released into the environment either unchanged or as metabolic by-products. It can take hundreds of years for these substances to be fully eliminated from nature. Therefore, there is a growing interest in identifying alternative anesthetic agents that are fully metabolized, do not produce waste, have a shorter duration of action, and pose less harm to ecosystems.

Recent clinical studies have shown that dexmedetomidine, when administered intraoperatively via infusion without a loading dose and in combination with inhalational agents, provides more stable hemodynamics and results in a shorter postoperative recovery period. Commonly used as a long-term sedative agent in intensive care units, dexmedetomidine has gained popularity in the intraoperative setting due to its stable hemodynamic profile, low incidence of withdrawal symptoms, and faster recovery.

In this study, it is aimed to demonstrate the potential use of dexmedetomidine-whose pharmacodynamic and pharmacokinetic properties are well-known to experienced anesthesiologists-as an alternative to inhalational anesthetic agents for the maintenance of anesthesia, particularly in the geriatric patient population.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 39 years

Classified as ASA physical status II-IV

Scheduled for elective endoscopic urological surgery (e.g., URS, TUR-B, PCNL, TUR-P)

Scheduled for postoperative follow-up in the Post-Anesthesia Care Unit (PACU)

Disqualifiers

Requirement for conversion to open surgery during the perioperative period

Patients who decline to participate in the study

Presence of neuropsychiatric disorders (e.g., dementia, Parkinson's disease, epilepsy, or history of head trauma)

History of alcohol or substance abuse

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine + Remifentanil

    Drug

    Anesthesia Protocol All patients will receive the same standardized induction regimen consisting of fentanyl (1 μg/kg), propofol (1 mg/kg), and rocuronium (0.5 mg/kg). Following induction, maintenance of general anesthesia will differ according to group allocation: In Group DR, anesthesia maintenance will be provided with dexmedetomidine administered as a continuous infusion without a loading dose, combined with remifentanil infusion. Remifentanil infusion rates will be adjusted as clinically required to maintain adequate hemodynamic stability and surgical anesthesia depth

  • Desflurane + Remifentanil

    Drug

    The investigators will administer desflurane combined with remifentanil for general anesthesia maintenance in this group.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Group DR: Dexmedetomidine + RemifentanilActive comparator 1 intervention
Group B: Group IR: Desflurane + RemifentanilActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Depth of anesthesia

Depth of anesthesia assessed using Bispectral Index (BIS) monitoring, with BIS values recorded during surgery. The target BIS range will be 40-60.

Time frame
Intraoperative period

Secondary outcomes

1

Intraoperative hemodynamic stability

Intraoperative hemodynamic stability assessed by mean arterial pressure (MAP) and heart rate (HR) values recorded during surgery.

Time frame
Intraoperative period
2

Quality of recovery

Quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire (score range 0-150; higher scores indicate better recovery).

Time frame
Postoperative day 1
3

Sedation Level

Sedation level assessed using the Richmond Agitation-Sedation Scale (RASS) (score range -5 to +4) where more negative scores indicate deeper sedation and positive scores indicate agitation

Time frame
Post-anesthesia care unit (PACU)

Other outcomes

1

Postoperative recovery time

Postoperative recovery time defined as the time to achieve an Aldrete score ≥9.

Time frame
Post-anesthesia care unit (PACU)
2

Postoperative pain intensity

Postoperative pain intensity assessed using the Visual Analog Scale (VAS; 0-10), where higher scores indicate worse pain.

Time frame
Up to 24 hours postoperatively

Sponsors and contacts

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