DexmedetomidineNCT07047898
The Effect of Dexmedetomidine on Postoperative Cognitive Function in Geriatric Patients
A study testing The group receiving dexmedetomidine infusion and The group not receiving dexmedetomidine infusion in people with Dexmedetomidine and Robotic Surgery, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In pelvic surgeries, using laparoscopic surgical procedures provides advantages such as reduced postoperative pain and complications, early mobilization, shorter hospital stays, lower costs, better cosmetic outcomes, and faster return to daily activities. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dexmedetomidine, Robotic Surgery, Geriatric Patients
- What is being tested?
- The group receiving dexmedetomidine infusion and The group not receiving dexmedetomidine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2025to 21 Aug 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 65 years of age
- Those with ASA 1,2,3
- Patients who underwent robotic urological surgery
- Those who underwent Mini Mental Test in the preoperative period
Who cannot join
- Those under 65 years of age
- Those with ASA score IV and above
- Those with advanced co-morbidities
- Patients who have converted robotic surgery to open surgery
- Those with morbid obesity
- Those with alcohol or drug addiction
Show all 11Show fewer
- Refusing to participate
- Those with a known history of psychiatric and neurological diseases
- Those with visual and hearing impairments
- Those who score below 24 on the Mini Mental Test
- Patients who are hemodynamically unstable peroperatively
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
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
About this study
Official title: The Effect of Dexmedetomidine on Postoperative Cognitive Function in Geriatric Patients Undergoing Robotic Urologic Surgery
In pelvic surgeries, using laparoscopic surgical procedures provides advantages such as reduced postoperative pain and complications, early mobilization, shorter hospital stays, lower costs, better cosmetic outcomes, and faster return to daily activities. In robotic surgeries, the instruments have superior maneuverability compared to the human wrist, allowing for more precise work in delicate areas with a three-dimensional view while eliminating the surgeon's hand tremor. On the other hand, despite advances in surgical techniques, anesthesia management, and intensive care, a significant proportion of geriatric patients experience cognitive decline after surgery. Postoperative cognitive function decline can reduce the quality of life and lead to significant damage to family and social support systems. Postoperative cognitive dysfunction (POCD), defined as a decline in cognitive function following surgeries performed under general anesthesia, is a common postoperative cognitive impairment, particularly in the elderly population. Studies have shown that the incidence of POCD in individuals aged 60 and above ranges between 20% and 40%. Additionally, POCD is associated with prolonged hospital stays, reduced mobility, and increased mortality. Patients undergoing robotic laparoscopic radical surgery assume the Trendelenburg position, which provides better exposure of the pelvic organs. However, in robotic-assisted laparoscopic surgeries, patients must be placed in a steep Trendelenburg position. Prolonged pneumoperitoneum and excessive head-down tilt can increase the permeability of the blood-brain barrier. As a result of the Trendelenburg position, intracranial pressure may increase, leading to brain hypoxia, inadequate cerebral blood flow, low arterial oxygen content, anemia, and high brain oxygen consumption. Impaired cerebral oxygenation can directly affect brain function. Compared to conventional laparoscopic surgery, patients undergoing robotic-assisted laparoscopic surgery tend to exhibit prolonged emergence from anesthesia and increased psychomotor agitation due to factors such as stress response, trauma, anesthesia, bleeding, and transfusion. This condition is influenced by factors such as decreased cerebral blood flow and hypotension. Therefore, real-time monitoring methods are needed to detect and address cerebral hypoxia. While diagnostic tools like computed tomography (CT), echocardiography (ECHO), electroencephalography (EEG), and magnetic resonance imaging (MRI) reveal brain damage at a later stage, near-infrared spectroscopy (NIRS) is a continuous, safe, and non-invasive method for detecting cerebral hypoxia. Identifying oxygen deficiency in the brain can allow adjustments in treatment strategies and help prevent postoperative cognitive dysfunction, potentially reducing patients' intensive care and hospital stay durations while minimizing complications. Recently, certain medications have been used to prevent postoperative cognitive dysfunction. Dexmedetomidine, a drug with neuroprotective properties, is commonly used perioperatively in patients undergoing surgery under general anesthesia. Pharmacologically, dexmedetomidine is an α2-adrenergic agonist with sedative, analgesic, anxiolytic, and diuretic effects. However, previous clinical studies evaluating the effects of dexmedetomidine on POCD in elderly patients have yielded inconsistent results. This study aims to investigate the effects of dexmedetomidine on recovery from anesthesia and postoperative cognitive function in elderly patients undergoing robotic urologic surgery, particularly focusing on its neuroprotective properties. Patients included in our study will be randomly divided into two groups. Both groups will undergo routine standard ASA monitoring, NIRS, and BIS monitoring. Both groups will receive standard anesthesia induction. Then, one group will receive sevoflurane + remifentanil, while the other group will receive dexmedetomidine and remifentanil infusion along with sevoflurane. Both patient groups will undergo the Mini-Mental State Examination (MMSE) before and after the operation. During the intraoperative period, anesthesia depth will be monitored using BIS (maintaining the depth between 40 and 60 for both groups), and oxygenation will be tracked using NIRS. Our study will include geriatric patients undergoing robotic urologic surgery. The patients will be randomly divided into two groups. The randomization process will be performed using a web-based randomization program (Sortition), which is defined for validity. The anesthesiologist providing anesthesia management and the anesthetist conducting the postoperative cognitive function monitoring will be different individuals. Patients who accept the study and undergo the preoperative Mini-Mental Test will be included in the study after postoperative assessments on the 24th hour and the 7th day.
- Conditions
- Dexmedetomidine, Robotic Surgery, Geriatric Patients
- Being tested
- The group receiving dexmedetomidine infusion, The group not receiving dexmedetomidine infusion
- Keywords
- Postoperative Cognitive Function, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group receiving dexmedetomidine infusionDrug
Dexmedetomidine will be administered intravenously at an infusion dose of 0.2-0.7 µg/kg/hour during the maintenance phase of anesthesia.
The group not receiving dexmedetomidine infusionDrug
Infusion will not be given.
| Study group | Role | What they receive |
|---|---|---|
| The group receiving dexmedetomidine infusion | Active comparator | Dexmedetomidine is a perioperative drug used for patients undergoing surgery under general anesthesia, which plays a role in brain and nerve protection. Dexmedetomidine is an α2-adrenergic agonist that pharmacologically exhibits effects such as sedation, analgesia, anxiolytic and diuresis, and has also been shown to have neuroprotective effects. Receives: Drug: The group receiving dexmedetomidine infusion |
| The group not receiving dexmedetomidine infusion | Active comparator | Standard anesthesia maintenance will be applied Receives: Drug: The group not receiving dexmedetomidine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cognitive dysfunction
In order to evaluate cognitive impairment in patients who have undergone Mini Mental Test (0-30) in the preoperative 24 hour , the mini mental test will be performed again at the 24th hour and 7th day postoperatively.
Measured: preoperative 24 hour postoperative 24th hour and 7th day
Secondary outcomes (1)
Recovery time
The patient's recovery after extubation will be evaluated with the Ramsey sedation scale(1-6)
Measured: postoperative 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study startAug 2025 (estimated)
- Primary completion11 Aug 2026 (estimated)
- Study completion21 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muruvvet Taskir Turan, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047898
- Sponsor's protocol ID
- AEŞH-EK-2025-072
- Status last verified
- Jul 2025
- First submitted
- 10 Apr 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on Postoperative Cognitive Function in Geriatric Patients Undergoing Robotic Urologic Surgery
- ClinicalTrials.gov ID
- NCT07047898
- Acronym / sponsor ID
- AEŞH-EK-2025-072
- Conditions
- Dexmedetomidine, Robotic Surgery, Geriatric Patients
- Keywords
- Postoperative Cognitive Function, recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- Aug 2025 (estimated)
- Primary completion
- 11 Aug 2026 (estimated)
- Study completion
- 21 Aug 2026 (estimated)
- First posted
- 2 Jul 2025 (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.
In pelvic surgeries, using laparoscopic surgical procedures provides advantages such as reduced postoperative pain and complications, early mobilization, shorter hospital stays, lower costs, better cosmetic outcomes, and faster return to daily activities. In robotic surgeries, the instruments have superior maneuverability compared to the human wrist, allowing for more precise work in delicate areas with a three-dimensional view while eliminating the surgeon's hand tremor. On the other hand, despite advances in surgical techniques, anesthesia management, and intensive care, a significant proportion of geriatric patients experience cognitive decline after surgery. Postoperative cognitive function decline can reduce the quality of life and lead to significant damage to family and social support systems. Postoperative cognitive dysfunction (POCD), defined as a decline in cognitive function following surgeries performed under general anesthesia, is a common postoperative cognitive impairment, particularly in the elderly population. Studies have shown that the incidence of POCD in individuals aged 60 and above ranges between 20% and 40%. Additionally, POCD is associated with prolonged hospital stays, reduced mobility, and increased mortality. Patients undergoing robotic laparoscopic radical surgery assume the Trendelenburg position, which provides better exposure of the pelvic organs. However, in robotic-assisted laparoscopic surgeries, patients must be placed in a steep Trendelenburg position. Prolonged pneumoperitoneum and excessive head-down tilt can increase the permeability of the blood-brain barrier. As a result of the Trendelenburg position, intracranial pressure may increase, leading to brain hypoxia, inadequate cerebral blood flow, low arterial oxygen content, anemia, and high brain oxygen consumption. Impaired cerebral oxygenation can directly affect brain function. Compared to conventional laparoscopic surgery, patients undergoing robotic-assisted laparoscopic surgery tend to exhibit prolonged emergence from anesthesia and increased psychomotor agitation due to factors such as stress response, trauma, anesthesia, bleeding, and transfusion. This condition is influenced by factors such as decreased cerebral blood flow and hypotension. Therefore, real-time monitoring methods are needed to detect and address cerebral hypoxia. While diagnostic tools like computed tomography (CT), echocardiography (ECHO), electroencephalography (EEG), and magnetic resonance imaging (MRI) reveal brain damage at a later stage, near-infrared spectroscopy (NIRS) is a continuous, safe, and non-invasive method for detecting cerebral hypoxia. Identifying oxygen deficiency in the brain can allow adjustments in treatment strategies and help prevent postoperative cognitive dysfunction, potentially reducing patients' intensive care and hospital stay durations while minimizing complications. Recently, certain medications have been used to prevent postoperative cognitive dysfunction. Dexmedetomidine, a drug with neuroprotective properties, is commonly used perioperatively in patients undergoing surgery under general anesthesia. Pharmacologically, dexmedetomidine is an α2-adrenergic agonist with sedative, analgesic, anxiolytic, and diuretic effects. However, previous clinical studies evaluating the effects of dexmedetomidine on POCD in elderly patients have yielded inconsistent results. This study aims to investigate the effects of dexmedetomidine on recovery from anesthesia and postoperative cognitive function in elderly patients undergoing robotic urologic surgery, particularly focusing on its neuroprotective properties. Patients included in our study will be randomly divided into two groups. Both groups will undergo routine standard ASA monitoring, NIRS, and BIS monitoring. Both groups will receive standard anesthesia induction. Then, one group will receive sevoflurane + remifentanil, while the other group will receive dexmedetomidine and remifentanil infusion along with sevoflurane. Both patient groups will undergo the Mini-Mental State Examination (MMSE) before and after the operation. During the intraoperative period, anesthesia depth will be monitored using BIS (maintaining the depth between 40 and 60 for both groups), and oxygenation will be tracked using NIRS. Our study will include geriatric patients undergoing robotic urologic surgery. The patients will be randomly divided into two groups. The randomization process will be performed using a web-based randomization program (Sortition), which is defined for validity. The anesthesiologist providing anesthesia management and the anesthetist conducting the postoperative cognitive function monitoring will be different individuals. Patients who accept the study and undergo the preoperative Mini-Mental Test will be included in the study after postoperative assessments on the 24th hour and the 7th day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group receiving dexmedetomidine infusion | Active comparator | Drug: The group receiving dexmedetomidine infusionDexmedetomidine is a perioperative drug used for patients undergoing surgery under general anesthesia, which plays a role in brain and nerve protection. Dexmedetomidine is an α2-adrenergic agonist that pharmacologically exhibits effects such as sedation, analgesia, anxiolytic and diuresis, and has also been shown to have neuroprotective effects. |
| The group not receiving dexmedetomidine infusion | Active comparator | Drug: The group not receiving dexmedetomidine infusionStandard anesthesia maintenance will be applied |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients over 65 years of age
- Those with ASA 1,2,3
- Patients who underwent robotic urological surgery
- Those who underwent Mini Mental Test in the preoperative period
Key exclusion criteria (11 listed)
- Those under 65 years of age
- Those with ASA score IV and above
- Those with advanced co-morbidities
- Patients who have converted robotic surgery to open surgery
- Those with morbid obesity
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 |
|---|---|---|
| The group receiving dexmedetomidine infusionDexmedetomidine will be administered intravenously at an infusion dose of 0.2-0.7 µg/kg/hour during the maintenance phase of anesthesia. | Drug | The group receiving dexmedetomidine infusion |
| The group not receiving dexmedetomidine infusionInfusion will not be given. | Drug | The group not receiving dexmedetomidine infusion |
Primary outcome
Postoperative cognitive dysfunction
Time frame: preoperative 24 hour postoperative 24th hour and 7th day
In order to evaluate cognitive impairment in patients who have undergone Mini Mental Test (0-30) in the preoperative 24 hour , the mini mental test will be performed again at the 24th hour and 7th day postoperatively.
1 secondary outcome
Recovery time
Time frame: postoperative 30 minute
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 2 Jul 2025.
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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 The group receiving dexmedetomidine infusion and The group not receiving dexmedetomidine infusion in people with Dexmedetomidine and Robotic Surgery, run by Ankara Etlik City 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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 2 Jul 2025. 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 MÜRÜVVET TAŞKIR TURAN, MD (09005065536934, taskirmuruvvet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative cognitive dysfunction (time frame: preoperative 24 hour postoperative 24th hour and 7th day). 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 2 Jul 2025.