Ureterorenoscopic LithotripsyNCT07363681
Inhalational Agents Versus Dexmedetomidine for Maintenance of General Anesthesia
A study testing Dexmedetomidine + Remifentanil and Desflurane + Remifentanil in people with Ureterorenoscopic Lithotripsy and Transurethral Resection of the Bladder, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 39 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Ureterorenoscopic Lithotripsy, Transurethral Resection of the Bladder, Percutaneous Nephrolithotomy
- What is being tested?
- Dexmedetomidine + Remifentanil and Desflurane + Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 9 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkoy dr. Sadi Konuk
Istanbul, Istanbul, 34140
Nalan Saygi Emir
About this study
Official title: Beyond Inhalational Agents: Dexmedetomidine for Maintenance of General Anesthesia - A Prospective Randomized Clinical 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.
Read the 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
- Conditions
- Ureterorenoscopic Lithotripsy, Transurethral Resection of the Bladder, Percutaneous Nephrolithotomy, Transurethral Resection of the Prostate
- Being tested
- Dexmedetomidine + Remifentanil, Desflurane + Remifentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine + RemifentanilDrug
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 + RemifentanilDrug
The investigators will administer desflurane combined with remifentanil for general anesthesia maintenance in this group.
| Study group | Role | What they receive |
|---|---|---|
| Group DR: Dexmedetomidine + Remifentanil | Active comparator | The investigators will administer dexmedetomidine combined with remifentanil for anesthesia maintenance in this patient group. Receives: Drug: Dexmedetomidine + Remifentanil |
| Group IR: Desflurane + Remifentanil | Active comparator | The investigators will administer desflurane combined with remifentanil for general anesthesia maintenance in this group. Receives: Drug: Desflurane + Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative period
Secondary outcomes (3)
Intraoperative hemodynamic stability
Intraoperative hemodynamic stability assessed by mean arterial pressure (MAP) and heart rate (HR) values recorded during surgery.
Measured: Intraoperative period
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).
Measured: Postoperative day 1
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
Measured: Post-anesthesia care unit (PACU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Oct 2024
- Primary completion1 Feb 2026 (estimated)
- Study completion9 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureterorenoscopic LithotripsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nalan Saygi Emir, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363681
- Sponsor's protocol ID
- 2023/176
- Status last verified
- Jun 2025
- First submitted
- 17 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Inhalational Agents: Dexmedetomidine for Maintenance of General Anesthesia - A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07363681
- Acronym / sponsor ID
- 2023/176
- Conditions
- Ureterorenoscopic Lithotripsy, Transurethral Resection of the Bladder, Percutaneous Nephrolithotomy, Transurethral Resection of the Prostate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 9 Mar 2026 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DR: Dexmedetomidine + Remifentanil | Active comparator | Drug: Dexmedetomidine + RemifentanilThe investigators will administer dexmedetomidine combined with remifentanil for anesthesia maintenance in this patient group. |
| Group IR: Desflurane + Remifentanil | Active comparator | Drug: Desflurane + RemifentanilThe investigators will administer desflurane combined with remifentanil for general anesthesia maintenance in this group. |
Who may qualify
- Ages
- 39 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine + RemifentanilAnesthesia 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 | Drug | Group DR: Dexmedetomidine + Remifentanil |
| Desflurane + RemifentanilThe investigators will administer desflurane combined with remifentanil for general anesthesia maintenance in this group. | Drug | Group IR: Desflurane + Remifentanil |
Primary outcome
Depth of anesthesia
Time frame: Intraoperative period
Depth of anesthesia assessed using Bispectral Index (BIS) monitoring, with BIS values recorded during surgery. The target BIS range will be 40-60.
3 secondary outcomes
Intraoperative hemodynamic stability
Time frame: Intraoperative period
Quality of recovery
Time frame: Postoperative day 1
Sedation Level
Time frame: Post-anesthesia care unit (PACU)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine + Remifentanil and Desflurane + Remifentanil in people with Ureterorenoscopic Lithotripsy and Transurethral Resection of the Bladder, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NALAN SAYGİ EMİR (00905422363672, nasaemir@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depth of anesthesia (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.