Inhalational Agents Versus Dexmedetomidine for Maintenance of General Anesthesia

NCT07363681 | Recruiting DMC

• 1 other identifier: 2023/176
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ureterorenoscopic Lithotripsy; Transurethral Resection of the Bladder; Percutaneous Nephrolithotomy; Transurethral Resection of the Prostate

Outcome Measures

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.

  Intraoperative period

Secondary Outcomes (3)

• Intraoperative hemodynamic stability

  Intraoperative period

• Quality of recovery

  Postoperative day 1

• Sedation Level

  Post-anesthesia care unit (PACU)

Other Outcomes (2)

• Postoperative recovery time

  Post-anesthesia care unit (PACU)

• Postoperative pain intensity

  Up to 24 hours postoperatively

Study Arms (2)

Group DR: Dexmedetomidine + Remifentanil

ACTIVE COMPARATOR

The investigators will administer dexmedetomidine combined with remifentanil for anesthesia maintenance in this patient group.

Drug: Dexmedetomidine + Remifentanil

Group IR: Desflurane + Remifentanil

ACTIVE COMPARATOR

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

Drug: Desflurane + Remifentanil

Interventions

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

Group DR: Dexmedetomidine + Remifentanil

Desflurane + Remifentanil DRUG

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

Group IR: Desflurane + Remifentanil

Eligibility Criteria

• Age: 39 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakirkoy dr. Sadi Konuk

Istanbul, Istanbul, 34140, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Remifentanil; Desflurane

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Central Study Contacts

NALAN SAYGİ EMİR

CONTACT

00905422363672; nasaemir@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Physician

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 23, 2026
• Study Start: October 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: March 9, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)