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Hypotension During SurgeryNCT06238973

Controlled Hypotension in Rhinoplasty and Septoplasty: Incidence of Cognitive Dysfunction and Delirium

A study testing Group Low and Group Middle in people with Hypotension During Surgery, run by Hitit University 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

Controlled hypotension application is a commonly preferred anesthesia practice during surgical procedures, particularly in regions with rich tissue perfusion, aiming to reduce bleeding, enhance surgical field visibility, and mitigate potential complications. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hypotension During Surgery
What is being tested?
Group Low and Group Middle
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Feb 2024to 15 Aug 2024
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • who will undergo rhinoplasty or septoplasty surgery
  • between the ages of 18-65
  • classified as ASA class I-II

Who cannot join

  • Patients with hypertension
  • Patients with diabetes mellitus
  • Patients with significant cardiac disease
  • Patients with vascular disease with lung, kidney, or liver parenchymal diseases
  • Patients with a history of cerebrovascular events
  • Patients with hypovolemia
  • those for whom perioperative controlled hypotension is contraindicated (including emergency surgeries, patients with bleeding diathesis, and those with heart valve disease)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hitit University Faculty of Medicince

    Çorum, Merkez, 19040

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Relationship Between the Level of Controlled Hypotension Applied During Rhinoplasty and Septoplasty Surgery and the Incidence of Postoperative Cognitive Dysfunction and Delirium

Controlled hypotension application is a commonly preferred anesthesia practice during surgical procedures, particularly in regions with rich tissue perfusion, aiming to reduce bleeding, enhance surgical field visibility, and mitigate potential complications. Preserving blood flow, especially to the brain, heart, and kidneys, is vital during this method. Previous studies on the subject have primarily focused on short-term effects regarding cognitive impairments, with limited research on the long-term impacts.

In our study, we aim to investigate how controlled hypotension application, administered to patients undergoing rhinoplasty or septoplasty surgery, specifically affects cerebral blood flow and its potential consequences on the development of short-term/medium-term/long-term cognitive impairments or delirium in the postoperative period.

Read the detailed description

Nasal congestion is a health issue that affects approximately 70% of the general population, with nasal septal deviations being the most common cause . Various nasal septal surgeries, such as septoplasty or rhinoplasty, are performed to address aesthetic concerns related to curvature and correct deviations. The most common issue encountered during these operations is bleeding, which hinders the visibility of the surgical field. To prevent bleeding in the surgical area, the Trendelenburg position and controlled hypotension practices are frequently preferred . Controlled hypotension is defined as the intentional, elective, and controlled reduction of systolic blood pressure to 80-90 mmHg, the reduction of mean arterial pressure (MAP) to 50-65 mmHg, or a 30-50% reduction in baseline MAP.

Controlled hypotension is employed to shorten the duration of surgical procedures, reduce bleeding, decrease the need for blood transfusion, and enhance the quality of surgery by providing a satisfactory and clear surgical field without causing organ dysfunction.

Cognitive function is a mental process encompassing an individual's learning, understanding of oneself and the world, and acquired knowledge and beliefs about the surroundings. It covers higher brain functions such as consciousness, attention, learning, memory, perception, orientation, intelligence, action, emotion, imagination, problem-solving, decision-making, speech, reading, writing, and calculation. Cognitive function disorders are classified into delirium, dementia, amnestic disorder, cognitive disorder not otherwise specified, and postoperative cognitive dysfunction (POCD). POCD is a cognitive impairment that most commonly manifests with memory and concentration disturbances, diagnosable through neuropsychiatric tests. It is objectively measured cognitive decline beyond the expected duration for normal recovery from the physiological and pharmacological effects of anesthesia and surgery. POCD can persist from one day to years after surgery, increasing hospital stay and costs, affecting patients of all age groups, but more prevalent in older individuals. Early risk factors for POCD include anesthesia duration, low educational level, multiple surgical histories, postoperative infection, and respiratory complications. Late POCD, on the other hand, is only correlated with age among the identified risk factors. Bispectral index (BIS) and near-infrared spectroscopy (NIRS) monitoring are utilized in the perioperative process to prevent POCD . Studies have shown that lower BIS values in patients are associated with less development of postoperative cognitive dysfunction . The results suggest that deep anesthesia may have a protective effect by reducing cerebral metabolism and blood flow. Cerebral oxygenation monitoring has also demonstrated potential usefulness in preventing the development of postoperative cognitive dysfunction. Methods used for detecting postoperative cognitive dysfunction include direct interviews, questionnaires, mental status assessment tests, and neuropsychological tests . The most commonly used test among these is the Mini-Mental State Examination (MMSE). The MMSE, developed by Folstein and colleagues in 1975, evaluates cognitive functions and covers questions related to time and place orientation, memory and recall, attention and calculation, orientation, language, and visual structuring. A modified Mini-Mental test is used for those with no education. Both tests have a maximum score of 30, with 0-9 indicating severe cognitive impairment, 10-19 moderate cognitive impairment, 20-26 mild cognitive impairment, and 27-30 normal cognitive function.

Delirium is characterized by the acute onset, fluctuating course, and features such as disruption of cognitive functions due to organic causes, changes in the sleep-wake cycle, and decreased attention and perception . It is more common in intensive care units and the postoperative period, with advanced age being a risk factor for delirium due to the use of multiple medications and physical limitations. Various systemic illnesses and conditions related to the central nervous system can lead to delirium.

"Delirium, as it exhibits fluctuation throughout the day, is not always easily recognizable, and since only a medical professional can apply DSM criteria, the diagnosis may be overlooked. Screening and diagnostic tools have been developed to be easily and quickly applied using DSM criteria, allowing not only physicians but also nurses and healthcare personnel to use them.

Several assessment tools have been developed to easily and quickly detect and evaluate delirium. The Confusion Assessment Method (CAM) is a screening tool consisting of four features: (a) acute onset and fluctuating mental status, (b) inattention, (c) disorganized thinking, and (d) altered levels of consciousness.

Delirium can be diagnosed, especially using features (a) and (b), although (c) or (d) can be selectively used. For the intensive care unit, the CAM for the intensive care unit is a two-minute version of the CAM that can be easily applied in the intensive care unit with an accuracy of over 93%. Qualified personnel with appropriate training can apply CAM with high sensitivity.

The Richmond Agitation-Sedation Scale (RASS) is a tool used to assess the level of sedation/agitation. The DSM-5 guide states that a level of significantly decreased arousal above the level of coma (acutely onset) should be considered delirium, making RASS considered useful in diagnosing delirium.

The Delirium Rating Scale-Revised-98 (DRS-R-98) is useful in assessing the presence and severity of delirium but takes more time to administer than CAM. DRS-R-98 includes a relatively broader range of symptoms, comprising 3 diagnostic items and 13 severity items (total score ranging from 0 to 46, with a higher score indicating more severe delirium). It is suggested that a severity score of 15 or higher may indicate dementia or other psychiatric disorders.

Preventing the development of delirium is a primary approach in treatment. Identifying the causes of delirium and correcting the underlying organic disorder is the first treatment option. Measures to prevent delirium include ensuring the patient remains active, using auxiliary devices such as hearing aids and glasses when the patient is awake, avoiding restraints, and regulating the sleep-wake cycle. Therefore, nursing care is crucial. The secondary approach is treatment aimed at shortening the duration and reducing the severity of delirium in patients who develop delirium . Delirium is a condition where the sensitivity of the brain is increased. Medications that have anticholinergic side effects and lower the confusion threshold should be avoided. Delirium tremens, which occurs due to alcohol withdrawal, is treated with benzodiazepine derivatives . Benzodiazepine derivatives should not be used in treatment except for benzodiazepine deficiency and delirium tremens. If the patient with delirium is highly agitated and restless, haloperidol can be used as a sedative due to its low anticholinergic effect. Olanzapine, risperidone, and aripiprazole are second-generation antipsychotics. The use of these drugs is safe in delirium.

Being tested
Group Low, Group Middle
Keywords
controlled hypotension, nasal surgery, post operative cognitive dysfunction, post operative delirium
Medical subject headings
Emergence Delirium

What participants receive

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

  • Group LowOther

    In order to maintain arterial blood pressure within the range of 50-57 mmHg, Sevoflurane at a concentration of 0.5-1 MAC and Remifentanil at a rate of 0.05-0.3 mcg/kg/min will be used. If additional hypotensive agents are required, an infusion of Esmolol at a rate of 25-200 mcg/kg/min will be initiated.

  • Group MiddleOther

    In order to maintain arterial blood pressure within the range of 58-65 mmHg, Sevoflurane at a concentration of 0.5-1 MAC and Remifentanil at a rate of 0.05-0.3 mcg/kg/min will be used. If additional hypotensive agents are required, an infusion of Esmolol at a rate of 25-200 mcg/kg/min will be initiated.

Study groups in NCT06238973
Study groupRoleWhat they receive
Group LowActive comparatorGroup Low will aim to maintain an average arterial pressure in the range of 50-57 mmHg.
Receives: Other: Group Low
Group MiddleActive comparatorThe target is to keep the average arterial pressure within the range of 58-65 mmHg
Receives: Other: Group Middle

What is being measured

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

  1. Post Operative Cognitive Dysfunction with Mini Mental Test

    The assessment of patients' postoperative cognitive function will be conducted initially 24 hours after the surgery, and subsequently on the 7th day and at the 3rd month.

    Measured: 24 hours

Timeline

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

  1. First posted2 Feb 2024
  2. Study start6 Feb 2024
  3. Primary completion10 May 2024
  4. Study completion15 Aug 2024

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
Parallel groups
Model description
The group to be designated as Group A will aim to maintain an average arterial pressure in the range of 50-57 mmHg. For Group B, the target is to keep the average arterial pressure within the range of 58-65 mmHg.
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06238973
Sponsor's protocol ID
2023-101
Status last verified
Aug 2024
First submitted
23 Jan 2024
Last updated
21 Aug 2024
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 Group Low and Group Middle in people with Hypotension During Surgery, run by Hitit University 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 3 inclusion and 7 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 21 Aug 2024. 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?

Post Operative Cognitive Dysfunction with Mini Mental Test (time frame: 24 hours). 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 21 Aug 2024.

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