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).
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
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.
- Conditions
- Hypotension During Surgery
- 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 group | Role | What they receive |
|---|---|---|
| Group Low | Active comparator | Group Low will aim to maintain an average arterial pressure in the range of 50-57 mmHg. Receives: Other: Group Low |
| Group Middle | Active comparator | The 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.
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.
- First posted2 Feb 2024
- Study start6 Feb 2024
- Primary completion10 May 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selcuk KAYIR, Hitit University
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06238973
- Acronym / sponsor ID
- 2023-101
- Conditions
- Hypotension During Surgery
- Keywords
- controlled hypotension, nasal surgery, post operative cognitive dysfunction, post operative delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 2 Feb 2024 (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.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group Low | Active comparator | Other: Group LowGroup Low will aim to maintain an average arterial pressure in the range of 50-57 mmHg. |
| Group Middle | Active comparator | Other: Group MiddleThe target is to keep the average arterial pressure within the range of 58-65 mmHg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- who will undergo rhinoplasty or septoplasty surgery
- between the ages of 18-65
- classified as ASA class I-II
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Group LowIn 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. | Other | Group Low |
| Group MiddleIn 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. | Other | Group Middle |
Primary outcome
Post Operative Cognitive Dysfunction with Mini Mental Test
Time frame: 24 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.