Menu
Recruiting NCT07363681

Inhalational Agents Versus Dexmedetomidine for Maintenance of General Anesthesia

No phase Interventional Ureterorenoscopic Lithotripsy Transurethral Resection of the Bladder Percutaneous Nephrolithotomy Transurethral Resection of the Prostate

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine + Remifentanil, Desflurane + Remifentanil.
Who it may be relevant to
Registry conditions: Ureterorenoscopic Lithotripsy, Transurethral Resection of the Bladder, Percutaneous Nephrolithotomy, Transurethral Resection of the Prostate. Basic parameters: 39 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Beyond Inhalational Agents: Dexmedetomidine for Maintenance of General Anesthesia - A Prospective Randomized Clinical Trial

Overview

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.

Detailed description

Study Design and Setting This prospective, randomized clinical study was conducted at the Department of Anesthesiology and Reanimation, University of Health Sciences, Bakırköy Dr. Sadi Konuk Training and Research Hospital. Patient randomization was performed using a computer-based randomization tool (@randomizer).

Patient Selection A total of 150 patients over the age of 39 who provided informed consent and were scheduled for elective urological procedures at the Urology Department were enrolled in the study. The included surgeries were uretero-renoscopic lithotripsy (URS), transurethral resection of the bladder (TUR-B), percutaneous nephrolithotomy (PCNL), and transurethral resection of the prostate (TUR-P).

Anesthesia Protocol

Upon arrival to the operating room, standard monitoring was applied to all patients. Anesthesia induction and maintenance were carried out according to randomization:

Group DR: Dexmedetomidine + Remifentanil

Group IR: Desflurane + Remifentanil

Intraoperative and Postoperative Data Collection

During surgery, anesthesia depth and hemodynamic parameters were continuously monitored and recorded. At the end of the procedure, the following postoperative data were collected:

Visual Analog Scale (VAS) for pain

Richmond Agitation-Sedation Scale (RASS)

Modified Aldrete Score

The hospital unit/ward to which the patient was transferred

Interventions

  • Drug Dexmedetomidine + Remifentanil
    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
  • Drug Desflurane + Remifentanil
    The investigators will administer desflurane combined with remifentanil for general anesthesia maintenance in this group.

Primary outcome measures

  • Depth of anesthesia [Time frame: Intraoperative period]
Secondary outcome measures (3)
  • Intraoperative hemodynamic stability [Time frame: Intraoperative period]
  • Quality of recovery [Time frame: Postoperative day 1]
  • Sedation Level [Time frame: Post-anesthesia care unit (PACU)]

Eligibility criteria

Inclusion criteria

  • 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)
  • Ability to provide written informed consent

Exclusion criteria

  • 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
  • Use of psychoactive medications
  • Inability to communicate adequately for any reason

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Bakirkoy dr. Sadi Konuk — Istanbul

Identifiers

NCT: NCT07363681 · 2023/176

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗