Neurosurgical SurgerySedo AnalgesiaNCT07148544
The Effect of the Sedo-Analgesia Protocol Applied to Intensive Care Unit Patients on Patient Outcomes
A study testing Sedo analgesia protocol in people with Neurosurgical Surgery and Sedo-analgesia, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Neurosurgical interventions are a leading cause of death and disability in adults, and managing intracranial hypertension in the acute phase is a critical treatment process to prevent secondary brain injury . Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neurosurgical Surgery, Sedo-analgesia, İntensive Care
- What is being tested?
- Sedo analgesia protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age,
- Undergoing elective or emergency neurosurgical surgery and admitted to intensive care after surgery,
- Postoperative Glasgow Coma Score 9>GCS <13,
- Requiring mechanical ventilation for at least 24 hours,
- Having a RASS score ≥ -4,
- Are hemodynamically stable,
- Receiving intermittent sedation,
- Patients whose relatives consent to the study will be included in the sample criteria.
Who cannot join
- Those with alcohol or substance abuse,
- Those with known hearing loss,
- Those diagnosed with brain death,
- Those requiring deep sedation, such as those requiring the administration of muscle relaxants, a body mass index (BMI) > 30, or those with conditions that affect consciousness such as hypercapnia, hyperglycemia, or hypoglycemic coma, or those requiring deep sedation such as pulmonary hypertension,
- Those with cognitive impairment such as epilepsy surgery, Huntington's disease, or frontal lobe or cerebral cortex damage,
- Those with any disease that impairs thermoregulation, such as damage to the hypothalamus, which controls the sleep-wake cycle, or damage to the thalamus, which causes disorders such as impaired brain motor functions,
Show all 12Show fewer
- Those with quadriplegia,
- Those with a serious pulmonary condition (Chronic Obstructive Pulmonary Disease (COPD), asthma, pneumonia, pulmonary embolism, etc.),
- Those with an allergy to opioids (e.g., fentanyl, remifentanil, sufentanil, morphine),
- Those with severe liver disease and renal dysfunction.
- Psychiatric history (schizophrenia, mania, delirium, cognitive impairment, mental retardation).
- Patients who develop brain damage or complications during the study (such as a GCS < 9 drop, rebleeding, status epilepticus, convulsions, mental status disturbance/delirium, vomiting, tremor, myoclonus) will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
TC Adana City Training and Research Hospital
Adana
About this study
Neurosurgical interventions are a leading cause of death and disability in adults, and managing intracranial hypertension in the acute phase is a critical treatment process to prevent secondary brain injury . Among surgical and medical interventions to control intracranial pressure, appropriate sedoanalgesia protocols can provide comfort to patients and directly control intracranial pressure by regulating cerebral metabolism . Appropriate sedoanalgesia has been reported in the literature to reduce cerebral metabolic rate, cerebral blood flow, and cerebral blood volume by resting the brain, and has been observed to improve elevated intracranial pressure. Resting the brain means a decrease in cerebral metabolic rate, allowing it to utilize energy more efficiently . This decrease in the brain's need for blood supply decreases, thereby decreasing cerebral blood flow. This reduction in blood flow can help reduce intracranial pressure, as excessive blood flow and fluid accumulation can lead to elevated intracranial pressure. In this regard, sedoanalgesia applications help patients become more stable and better maintain cerebral perfusion pressure . This can help preserve brain function by ensuring adequate oxygen and nutrients to brain tissue . In this context, sedoanalgesia is an important tool in managing intracranial pressure and can be used strategically to improve brain health.
However, inadequate sedoanalgesia may fail to achieve intended treatment goals, while excessive sedoanalgesia can lead to complications associated with lethal sedation. Therefore, it is important to determine the appropriate sedoanalgesia protocol and continuously monitor patient outcomes (such as vital signs, blood gas parameters, pain, sedation scores, and GCS).
Read more
As healthcare professionals, nurses, along with physicians, are the decision-makers and implementers in the sedoanalgesia management of critically ill patients in intensive care, ensuring optimal sedoanalgesia, achieving the desired level of sedoanalgesia, optimizing patient comfort, ensuring patient safety, and maintaining sedoanalgesia when indicated. Therefore, our study was designed to evaluate the impact of the sedoanalgesia protocol applied to intensive care patients, including neurosurgical patients, on patient outcomes and is believed to guide the literature.
Keywords: Neurosurgical surgery, Sedo-analgesia, Intensive care, Nursing care
Read the detailed description
The study is planned as a randomized controlled intervention study to evaluate the effect of the sedo-analgesia protocol applied to intensive care patients on patient outcomes.
- Conditions
- Neurosurgical Surgery, Sedo-analgesia, İntensive Care, Nursing Care
- Being tested
- Sedo analgesia protocol, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedo analgesia protocolOther
Nurse-Controlled Sedo-Analgesia Protocol
control groupOther
The clinic's routine sedation analgesia management plan will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | The control group will receive the clinic's routine sedation-analgesia management plan. Patients will be monitored and their vital signs will be recorded upon admission to the intensive care unit. Medications will be administered according to the physician's orders based on improved treatment and analgesia. The nurse responsible for the patient will administer sedatives based on their own observation/assessment and the physician's order, without any sedation-analgesia protocol. The nurse responsible for the patient will also record all treatments as directed by the physician. During follow-up, data collection tools (RASS, HSF, NVPS, and CPOT) will be used to record patients' pain, anxiety, sedation level, GCS, blood gases, and vital signs twice daily, taking into account non-busy family visits and nursing care hours, between 10:00 and 11:00 and 14:00 and 15:00 (before, during, and 30 minutes after). Receives: Other: control group |
| Experimental Group | Other | The experimental group will receive an algorithmic sedoanalgesia protocol led by a nurse, and alarm volume will be adjusted in accordance with WHO recommendations. To ensure the patient understands the concept of daytime, the brightness of the lights in the patient's room will be adjusted only after 10:00 PM, ensuring they do not disrupt treatment and care. The patient's primary nurse will then assess the RASS, NVPS, and CPOT for three days. Based on these assessments, the patient will adjust the medication infusion rate and strive to achieve the target scale value range. During follow-up, the researcher will play music twice daily, between 10:00 AM and 11:00 AM and 2:00 PM and 3:00 PM, taking into account non-busy family visits and nursing care hours. Music will be played using pre-recorded music from selected Musi Cure albums for three days. Music will be played for 30 minutes at 10:00 AM and 2:00 PM. Data will be recorded using data collection tools. Receives: Other: Sedo analgesia protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Outcomes Form (HSF)
The Patient Information Form consists of eight questions regarding patient information.
Patient Outcomes Form (HSF): This form was developed by researchers based on a literature review to monitor blood gas parameters, vital signs, pain, medication dosage, GCS, NVPS, CPOT, and RASS levels in patients in the experimental and control groups.
Measured: 1 year, 2 years
Adult Nonverbal Pain Scale (NVPS
Adult Nonverbal Pain Scale (NVPS): This scale was developed to assess pain during painful procedures in patients who cannot communicate verbally. It is an important tool for determining pain levels and developing appropriate treatment and care strategies, especially in patients who cannot express pain.
Measured: 1 year, 2 years
Intensive Care Pain Observation Scale (CPOT)
Intensive Care Pain Observation Scale (CPOT): This scale is used to assess pain in patients in the intensive care unit.
Measured: 1 year, 2 years
Ricmond Sedation Agitation Scale (RASS
Ricmond Sedation Agitation Scale (RASS): This scale is used to determine the sedation and agitation levels of seriously ill patients undergoing mechanical ventilation.
Measured: 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Jul 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurosurgical SurgeryStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Research Projects Coordination Unit
- Responsible party
- Principal investigator, Ceylan Kisial, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148544
- Sponsor's protocol ID
- CU-SBF-CK-02
- Other IDs
- TDK-2025-17634
- Acronym
- Sedo Analgesia
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For now, I am thinking of publishing it first in my article and doctoral thesis.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Sedo-Analgesia Protocol Applied to Intensive Care Unit Patients on Patient Outcomes
- ClinicalTrials.gov ID
- NCT07148544
- Acronym / sponsor ID
- Sedo Analgesia / CU-SBF-CK-02
- Conditions
- Neurosurgical Surgery, Sedo-analgesia, İntensive Care, Nursing Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Collaborators
- Scientific Research Projects Coordination Unit
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 29 Aug 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.
Neurosurgical interventions are a leading cause of death and disability in adults, and managing intracranial hypertension in the acute phase is a critical treatment process to prevent secondary brain injury . Among surgical and medical interventions to control intracranial pressure, appropriate sedoanalgesia protocols can provide comfort to patients and directly control intracranial pressure by regulating cerebral metabolism . Appropriate sedoanalgesia has been reported in the literature to reduce cerebral metabolic rate, cerebral blood flow, and cerebral blood volume by resting the brain, and has been observed to improve elevated intracranial pressure. Resting the brain means a decrease in cerebral metabolic rate, allowing it to utilize energy more efficiently . This decrease in the brain's need for blood supply decreases, thereby decreasing cerebral blood flow. This reduction in blood flow can help reduce intracranial pressure, as excessive blood flow and fluid accumulation can lead to elevated intracranial pressure. In this regard, sedoanalgesia applications help patients become more stable and better maintain cerebral perfusion pressure . This can help preserve brain function by ensuring adequate oxygen and nutrients to brain tissue . In this context, sedoanalgesia is an important tool in managing intracranial pressure and can be used strategically to improve brain health.
However, inadequate sedoanalgesia may fail to achieve intended treatment goals, while excessive sedoanalgesia can lead to complications associated with lethal sedation. Therefore, it is important to determine the appropriate sedoanalgesia protocol and continuously monitor patient outcomes (such as vital signs, blood gas parameters, pain, sedation scores, and GCS).
As healthcare professionals, nurses, along with physicians, are the decision-makers and implementers in the sedoanalgesia management of critically ill patients in intensive care, ensuring optimal sedoanalgesia, achieving the desired level of sedoanalgesia, optimizing patient comfort, ensuring patient safety, and maintaining sedoanalgesia when indicated. Therefore, our study was designed to evaluate the impact of the sedoanalgesia protocol applied to intensive care patients, including neurosurgical patients, on patient outcomes and is believed to guide the literature.
Keywords: Neurosurgical surgery, Sedo-analgesia, Intensive care, Nursing care
Detailed description
The study is planned as a randomized controlled intervention study to evaluate the effect of the sedo-analgesia protocol applied to intensive care patients on patient outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: control groupThe control group will receive the clinic's routine sedation-analgesia management plan. Patients will be monitored and their vital signs will be recorded upon admission to the intensive care unit. Medications will be administered according to the physician's orders based on improved treatment and analgesia. The nurse responsible for the patient will administer sedatives based on their own observation/assessment and the physician's order, without any sedation-analgesia protocol. The nurse responsible for the patient will also record all treatments as directed by the physician. During follow-up, data collection tools (RASS, HSF, NVPS, and CPOT) will be used to record patients' pain, anxiety, sedation level, GCS, blood gases, and vital signs twice daily, taking into account non-busy family visits and nursing care hours, between 10:00 and 11:00 and 14:00 and 15:00 (before, during, and 30 minutes after). |
| Experimental Group | Other | Other: Sedo analgesia protocolThe experimental group will receive an algorithmic sedoanalgesia protocol led by a nurse, and alarm volume will be adjusted in accordance with WHO recommendations. To ensure the patient understands the concept of daytime, the brightness of the lights in the patient's room will be adjusted only after 10:00 PM, ensuring they do not disrupt treatment and care. The patient's primary nurse will then assess the RASS, NVPS, and CPOT for three days. Based on these assessments, the patient will adjust the medication infusion rate and strive to achieve the target scale value range. During follow-up, the researcher will play music twice daily, between 10:00 AM and 11:00 AM and 2:00 PM and 3:00 PM, taking into account non-busy family visits and nursing care hours. Music will be played using pre-recorded music from selected Musi Cure albums for three days. Music will be played for 30 minutes at 10:00 AM and 2:00 PM. Data will be recorded using data collection tools. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over 18 years of age,
- Undergoing elective or emergency neurosurgical surgery and admitted to intensive care after surgery,
- Postoperative Glasgow Coma Score 9>GCS <13,
- Requiring mechanical ventilation for at least 24 hours,
- Having a RASS score ≥ -4,
Key exclusion criteria (12 listed)
- Those with alcohol or substance abuse,
- Those with known hearing loss,
- Those diagnosed with brain death,
- Those requiring deep sedation, such as those requiring the administration of muscle relaxants, a body mass index (BMI) > 30, or those with conditions that affect consciousness such as hypercapnia, hyperglycemia, or hypoglycemic coma, or those requiring deep sedation such as pulmonary hypertension,
- Those with cognitive impairment such as epilepsy surgery, Huntington's disease, or frontal lobe or cerebral cortex damage,
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 |
|---|---|---|
| Sedo analgesia protocolNurse-Controlled Sedo-Analgesia Protocol | Other | Experimental Group |
| control groupThe clinic's routine sedation analgesia management plan will be implemented. | Other | Control Group |
Primary outcome
Patient Outcomes Form (HSF)
Time frame: 1 year, 2 years
The Patient Information Form consists of eight questions regarding patient information. Patient Outcomes Form (HSF): This form was developed by researchers based on a literature review to monitor blood gas parameters, vital signs, pain, medication dosage, GCS, NVPS, CPOT, and RASS levels in patients in the experimental and control groups.
Adult Nonverbal Pain Scale (NVPS
Time frame: 1 year, 2 years
Adult Nonverbal Pain Scale (NVPS): This scale was developed to assess pain during painful procedures in patients who cannot communicate verbally. It is an important tool for determining pain levels and developing appropriate treatment and care strategies, especially in patients who cannot express pain.
Intensive Care Pain Observation Scale (CPOT)
Time frame: 1 year, 2 years
Intensive Care Pain Observation Scale (CPOT): This scale is used to assess pain in patients in the intensive care unit.
Ricmond Sedation Agitation Scale (RASS
Time frame: 1 year, 2 years
Ricmond Sedation Agitation Scale (RASS): This scale is used to determine the sedation and agitation levels of seriously ill patients undergoing mechanical ventilation.
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 29 Aug 2025.
- Individual participant dataSharing planned: No. For now, I am thinking of publishing it first in my article and doctoral thesis.
Related trials for Neurosurgical Surgery
RecruitingObservational study
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
RecruitingPhase 1/2
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
Malignant Brain Neoplasm, Malignant Glioma
RecruitingObservational study
Immiseal™ Dural Sealant Post-Market Registry Study
Dural Defect, Cerebrospinal Fluid Leak
RecruitingPhase 3
Levetiracetam for Seizure Prevention After Brain Tumor Surgery
Postoperative Seizures After Brain Tumor Surgery
Not yet recruitingObservational study
Validation of an Ex Vivo Calf Brain Force Detection System for Neurosurgical Simulation Training
Surgical Education
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 Sedo analgesia protocol in people with Neurosurgical Surgery and Sedo-analgesia, run by Cukurova 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 8 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 29 Aug 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?
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?
Patient Outcomes Form (HSF) (time frame: 1 year, 2 years). The study lists 4 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 29 Aug 2025.