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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).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

MÜRÜVVET TAŞKIR TURAN, MD contact

09005065536934

taskirmuruvvet@gmail.com

MUSA ZENGİN, Associate Professor contact

00905307716235

musazengin@gmail.com

Turkey (Türkiye)1 site
  • Ankara Etlik City Hospital

    Yenimahalle, Ankara, 06170

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07047898
Study groupRoleWhat they receive
The group receiving dexmedetomidine infusionActive comparatorDexmedetomidine 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 infusionActive comparatorStandard 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.

  1. 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)
  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.

  1. First posted2 Jul 2025
  2. Study startAug 2025 (estimated)
  3. Primary completion11 Aug 2026 (estimated)
  4. Study completion21 Aug 2026 (estimated)

Resources

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)
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

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.

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