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General AnesthesiaNCT07505550

The Effect of Positive End-Expiratory Pressure Levels on Perfusion Index and Neurocognitive Functions in Geriatric Patients

A study testing PEEP levels in people with General Anesthesia and Elective Laparoscopic Cholecystectomy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

With the increasing geriatric population, age-related physiological changes and common comorbidities increase the risk of surgical and anesthesia-related complications in this patient group. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
PEEP levels
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Apr 2025to 29 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

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 who are 65 years and older
  • Patients in the ASA I-III risk group
  • Under elective conditions, patients those undergo elective laparoscopic cholecystectomy
  • Voluntary patients

Who cannot join

  • Patients under age 65
  • Emergency surgical procedures
  • Patients with neurological or psychiatric disorders
  • Patients with severe restrictive or obstructive lung disease
  • Patients with serious cardiac pathology (EF<40 or presence of arrhythmia)
  • Patients with peripheral artery disease
Show all 9Show fewer
  • Patients with increased intracranial pressure
  • Morbidly obese patients
  • Patients do not want to participate in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital

    Ankara, Çankaya, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effect of Different Positive End-Expiratory Pressure (PEEP) Levels on Perfusion Index (PI) and Neurocognitive Functions in Geriatric Patients Undergoing Laparoscopic Cholecystectomy Surgery

With the increasing geriatric population, age-related physiological changes and common comorbidities increase the risk of surgical and anesthesia-related complications in this patient group. Therefore, careful planning of anesthesia management and ventilation strategies is crucial to achieve safe and successful clinical outcomes. Positive end-expiratory pressure (PEEP), one of these strategies, should be applied with careful consideration of the balance between ensuring oxygenation and maintaining cardiovascular stability in geriatric patients. Early detection of hypoperfusion during the intraoperative period is also an important part of perioperative management. To this end, near-infrared spectroscopy (NIRS) is used as a noninvasive monitoring method to assess cerebral oxygenation, while the perfusion index (PI) is used to evaluate peripheral circulation, providing clinicians with valuable information for predicting potential complications. However, one of the most important neurological complications that can occur after surgery in geriatric patients is postoperative cognitive dysfunction (POCD). The Mini-Mental State Examination (MMSE) is widely preferred for assessing cognitive function during the perioperative period due to its ease of application and reliability.

The primary objective of this study is to investigate the effects of different PEEP levels on PI in geriatric patients undergoing laparoscopic cholecystectomy and to reveal changes in neurocognitive function by comparing preoperative and postoperative MMSE scores. Our secondary objectives are to evaluate the effects of PEEP on NIRS values and to analyze the possible relationships between NIRS, PI, hemodynamic parameters, and MMSE scores.

Read the detailed description

This study was conducted at the General Surgery Operating Room of Ankara Bilkent City Hospital, Ministry of Health, Turkey, with a total of 78 patients aged 65 years and older who were scheduled to undergo elective laparoscopic cholecystectomy. The study was designed as a prospective randomized controlled trial. Using a computer-assisted randomization method, the 78 patients were divided into three groups. Group 5 was ventilated with 5 cmH₂O PEEP, Group 7 with 7 cmH₂O PEEP, and Group 9 with 9 cmH₂O PEEP. On the day of surgery, patients' age, gender, height, weight, body mass index (BMI), comorbidities, medications taken regularly, surgical history, and education level were recorded using a standardized data form in the preoperative waiting area. The Mini Mental State Examination (MMSE) was administered to all patients 2 hours before surgery. After patients were taken to the operating room, noninvasive arterial blood pressure, electrocardiography (ECG), and pulse oximetry were performed as part of standard monitoring. Additionally, four-channel frontal EEG-based SedLine® (Patient State Index, PSI; Masimo Corporation, Irvine, CA, USA) monitoring was used to monitor anesthesia depth, and NIRS (O3® regional oximetry, Masimo Corporation, Irvine, CA, USA) monitoring was used to assess cerebral oxygenation. After cleaning the forehead area with an appropriate antiseptic, the SedLine® PSI electrode and O3® NIRS sensors were placed, and baseline values were recorded. For peripheral perfusion monitoring, the PI probe (Masimo Rainbow® Pulse CO-Oximetry, Masimo Corporation, Irvine, CA, USA) was placed on the third finger of the hand without the noninvasive blood pressure cuff. The hand was wrapped to reduce optical interference from ambient light and maintain thermal equilibrium. Before anesthesia induction, 3 minutes of preoxygenation was administered with 100% oxygen via a balloon mask. Anesthesia induction was then performed with fentanyl (2 mcg/kg), lidocaine (1 mg/kg), propofol (2 mg/kg), and rocuronium (0.6 mg/kg); midazolam was not administered. After achieving adequate depth of anesthesia, an endotracheal tube of appropriate size was placed in the patient. Ventilator settings were adjusted to a 50:50 oxygen-air mixture and a fresh gas flow of 2 L/min, targeting a tidal volume of 6-8 mL/kg based on ideal body weight and maintaining EtCO₂ within the range of 35-45 mmHg. PEEP was applied at a level determined by randomization in each patient. Anesthesia maintenance was achieved with sevoflurane and remifentanil infusion (0.01-0.1 mcg/kg/min) to maintain a target PSI range of 25-50. An orogastric tube was placed for gastric decompression. The surgical procedure was performed using the standard laparoscopic cholecystectomy technique. Pneumoperitoneum pressure was adjusted and maintained at 10-12 mmHg; the operating table was positioned at approximately 30° reverse Trendelenburg. Operating room temperature was maintained at 18-20 °C. Parameters evaluated (SAP, DAP, MAP, heart rate, SpO₂, PI, PSI, NIRS left and right) before and after anesthesia induction; after intubation; before pneumoperitoneum and at 1, 5, 10, 15, 30, 45, and 60 minutes after the start of pneumoperitoneum; every 30 minutes thereafter; and also at the end of pneumoperitoneum, at the end of surgery, and after extubation. Additionally, the hemoglobin levels at admission and discharge, the total amount of fluid administered, and the duration of anesthesia and surgery were also recorded. For postoperative pain management, patients received standard tramadol 1 mg/kg IV and paracetamol 1 g IV after gallbladder removal. Following the operation, 2 mg/kg sugammadex IV was administered, and patients were extubated once they began spontaneous breathing. After recovery in the operating room, patients were transferred to the postoperative recovery room. On postoperative day 1, patients underwent the MMSE test, and the results were recorded. Additionally, if any complications developed during the postoperative period, this was noted.

Being tested
PEEP levels
Keywords
Geriatric Patient, Laparoscopic Cholecystectomy, Near Infrared Spectroscopy, Perfusion Index, Positive End-Expiratory Pressure, Post-Operative Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEEP levelsOther

    78 patients undergoing elective surgery in the General Surgery Operating Room were divided into three groups using a computer-assisted randomization method. Group 5 was ventilated with 5 cmH₂O PEEP, Group 7 with 7 cmH₂O PEEP, and Group 9 with 9 cmH₂O PEEP.

Study groups in NCT07505550
Study groupRoleWhat they receive
5 cmH₂O PEEP VentilationActive comparatorGroup 5 was ventilated with 5 cmH₂O PEEP.
Receives: Other: PEEP levels
7 cmH₂O PEEP VentilationActive comparatorGroup 7 was ventilated with 7 cmH₂O PEEP.
Receives: Other: PEEP levels
9 cmH₂O PEEP VentilationActive comparatorGroup 9 was ventilated with 9 cmH₂O PEEP.
Receives: Other: PEEP levels

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neurocognitive functions

    The diagnosis of postoperative cognitive dysfunction is based on the evaluation of differences in preoperative and postoperative cognitive performance. One of the most commonly used methods for assessing cognitive functions is the Mini-Mental State Examination (MMSE). The MMSE covers subheadings such as orientation, memory, language, attention, calculation, and recall, and is scored out of 30 points. Results are interpreted as follows: 24-30 points indicate normal cognitive function, 18-23 points indicate mild cognitive impairment, and 0-17 points indicate moderate to severe cognitive impairment.

    Measured: 2 hours before the operation and on the first postoperative day, The MMSE test was administered again to patients and the results were recorded.

  2. Evaluate changes in perfusion index (PI)

    Perfusion index (PI) is defined as the ratio of the pulsatile signal obtained by photoplethysmography to the nonpulsatile signal. Photoplethysmography is a noninvasive, rapidly applicable method widely used in intraoperative patient monitoring. PI is an indirect indicator of central and peripheral perfusion and is primarily determined by the sympathetic-parasympathetic balance that regulates cardiac output and vascular tone. Changes in PI were evaluated at different applied PEEP levels.

    Measured: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.

Secondary outcomes (4)
  1. Evaluate changes in near infrared spectroscopy (NIRS)

    NIRS is a method that uses near-infrared spectroscopy technology to noninvasively assess the oxygenation status of tissues. In NIRS monitoring, an initial rSO₂ level below 40% or a decrease of more than 25% from the baseline measurement is considered indicative of cerebral ischemia. Changes in NIRS were evaluated at different applied PEEP levels.

    Measured: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.

  2. To determine the possible correlations between NIRS and hemodynamic data

    Measured: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.

  3. To determine the possible correlations between PI and hemodynamic data

    Measured: Baseline, 1 minute after anesthesia induction; 1 minute after intubation; 1 minute before pneumoperitoneum;at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum;1 minutes after at the end of pneumoperitoneum, surgery and extubation.

  4. To determine the possible correlations between PI and MMSE scores

    PI was recorded before and after anesthesia induction; 1 minute after intubation; before pneumoperitoneum; at 1, 5, 10, 15, 30, 45, 60, 90, 120 and 150 minutes after pneumoperitoneum; and at the end of pneumoperitoneum and surgery. MMSE was assessed 2 hours before surgery and on postoperative day 1.

    Measured: 2 hours before surgery through postoperative day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study start2 Apr 2025
  3. Primary completion15 Aug 2025
  4. Study completion29 Aug 2025

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
Screening
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07505550
Sponsor's protocol ID
Geriatric and PEEP
Status last verified
Mar 2026
First submitted
18 Feb 2026
Last updated
1 Apr 2026
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 PEEP levels in people with General Anesthesia and Elective Laparoscopic Cholecystectomy, run by Ankara City Hospital Bilkent 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 9 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: finished, as of the sponsor's last update on 1 Apr 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurocognitive functions (time frame: 2 hours before the operation and on the first postoperative day, The MMSE test was administered again to patients and the results were recorded.). The study lists 2 primary outcomes in all. 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 1 Apr 2026.

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