Postoperative Cognitive DysfunctionProDex-POCDNCT05398757
Propofol and Dexmedetomidin vs Midazolam Intraoperative Sedation and POCD
A study testing Mini mental state exame (MMSE), Digit Symbol Substitution Test (DSST) and Numeric rating Scale (NRS) in people with Postoperative Cognitive Dysfunction and Postoperative Pain, Acute, run by Osijek University Hospital at 1 site in Croatia.
Trial summary
This study will examine the effect of intraoperative sedation with midazolam, propofol and dexemdetomidine on the occurrence of postoperative cognitive impairment in patients undergoing surgical treatment of pertrochanteric fracture of the femur. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction, Postoperative Pain, Acute, Pertrochanteric Fracture
- What is being tested?
- Mini mental state exame (MMSE), Digit Symbol Substitution Test (DSST) and Numeric rating Scale (NRS)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Jul 2022to 1 Mar 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Pertrochanteric fracture surgery
- Informed consent signed
Who cannot join
- MMSE before surgery < 17
- Allergy on midazolam, propofol or dexemdetomidine
- Contraindication for neuroaxial anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intraoperative Administration of Dexmedetomidine, Propofol and Midazolam on Postoperative Levels of Inflammatory Markers and Development of Postoperative Cognitive Dysfunction After Pertrochanteric Fracture Surgery.
This study will examine the effect of intraoperative sedation with midazolam, propofol and dexemdetomidine on the occurrence of postoperative cognitive impairment in patients undergoing surgical treatment of pertrochanteric fracture of the femur.
Read the detailed description
Patients undergoing surgical treatment of pertrochanteric femoral fracture by intramedullary fixation will be included in the study. Patients will be older than 65 years and will belong to class I to III anesthesia risk according to the ASA classification. All patients included in the study will sign informed consent. Patients with dementia, mental illness, psychoorganically altered patients, and patients with a contraindication to dexmedetomidine, propofol, midazolam or with a contraindication to spinal anesthesia will be excluded from the study. All patients included in the study will have their blood taken for laboratory analysis of red blood cells, leukocytes, CRP, PCT, ChE and IL-6. Analyzes will be performed before the procedure, on the 1st, 3rd and 5th postoperative day. All patients will be tested for Mini mental state exame (MMSE) score before surgery to rule out pre-existing cognitive impairment, and those patients who have an MMSE value <17 prior to surgery will be excluded from the study. In premedication, patients will be randomized using three envelopes selected by the blind researcher for the contents of each envelope. According to envelope patients will be divided into three groups: dexmedetomidine group (DS), propofol group (PS) and midazolam group (MS). Neuroaxial spinal block with intrathecal administration of 12.5 - 15 mg 0.5% levobupivacaine in the intervertebral space L3 / L4 or L4 / L5 will be the technique of anesthesia. After spinal block, patients in the DS group will receive a continuous infusion of dexmedetomidine at a dose of 0.5 mcg / kg / h, patients in the PS group will receive a continuous infusion of propofol at a dose of 25-75 mcg / kg / min, while patients in the MS group will receive 0.05-0.07 mg / kg bolus i.v. midazolam. The total dose administered and the duration of surgery will be recorded. The volume of intraoperatively administered crystalloids or blood products will be recorded in all patients included in the study. In the postoperative period, pain will be measured with a numerical rating scale (NRS) 4, 8, 12 and 24 hours after surgery. All patients will receive the usual postoperative analgesia with metamizole and tramadol according to the protocol of the Department. On the 1st, 3rd and 5th postoperative days in the morning between 8.00 and 10.00, all patients will be tested for MMSE and Digit Symbol Substitution Test (DSST) score. A researcher who will evaluate MMSE and DSST values in the postoperative period will be blind to the drug that patients received intraoperatively.
- Being tested
- Mini mental state exame (MMSE), Digit Symbol Substitution Test (DSST), Numeric rating Scale (NRS), Postoperative inflammation, Midazolam
- Keywords
- Postoperative Cognitive Dysfunction, Postoperative pain, Pertrochanteric Fracture, IL-6, Dexmedetomidin, Propofol, Midazolam, Sedation
- Medical subject headings
- Postoperative Cognitive Complications, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini mental state exame (MMSE)Behavioural
Before the operation, and on the 1st, 3rd and 5th day after the operation, the Mini mental state exam (MMSE) score will be measured
Digit Symbol Substitution Test (DSST)Behavioural
Before the operation, and on the 1st, 3rd and 5th day after the operation, the Digit Symbol Substitution Test (DSST) score will be measured
Numeric rating Scale (NRS)Diagnostic test
4h, 8h, 12h and 24h after surgery, pain in all patients will be assessed by the NRS scale.
Postoperative inflammationDiagnostic test
All patients included in the study will have their blood taken for laboratory analysis of red blood cells, leukocytes, CRP, PCT, ChE and IL-6. Analyzes will be performed before the procedure, on the 1st, 3rd and 5th postoperative day.
MidazolamDrug
Also called Control - group M
For sedation during surgery, patients in midazolam group will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg after spinal anesthesia.
PropofolDrug
Also called Group P
For sedation during surgery, patients in propofol group will receive i.v. propofol in dose 25-27 mcg/kg/min.
DexmedetomidinDrug
Also called Group D
For sedation during surgery, patients in dexmedetomidin gropu will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Midazolam | Other | For sedation during surgery, patients will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg. Receives: Behavioral: Mini mental state exame (MMSE); Behavioral: Digit Symbol Substitution Test (DSST); Diagnostic Test: Numeric rating Scale (NRS); Diagnostic Test: Postoperative inflammation; Drug: Midazolam |
| Propofol | Active comparator | For sedation during surgery, patients will receive i.v. propofol in dose 25-27 mcg/kg/min. Receives: Behavioral: Mini mental state exame (MMSE); Behavioral: Digit Symbol Substitution Test (DSST); Diagnostic Test: Numeric rating Scale (NRS); Diagnostic Test: Postoperative inflammation; Drug: Propofol |
| Dexmedetomidin | Active comparator | For sedation during surgery, patients will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h Receives: Behavioral: Mini mental state exame (MMSE); Behavioral: Digit Symbol Substitution Test (DSST); Diagnostic Test: Numeric rating Scale (NRS); Diagnostic Test: Postoperative inflammation; Drug: Dexmedetomidin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of postoperative cognitive dysfunction (POCD) measured by MMSE
The incidence of POCD with respect to intraoperative sedation in the postoperative period will be measured by MMSE test on the first, third and fifth postoperative day. An absolute z-score greater than 1.96 in postoperative testing or a decrease in the postoperative MMSE value by more than 20% relative to the preoperative value will be considered the occurrence of POCD in the postoperative period.
Measured: 5 days
Occurrence of postoperative cognitive dysfunction (POCD) measured by DSST
The incidence of POCD with respect to intraoperative sedation in the postoperative period will be measured by DSST on the first, third and fifth postoperative day. An absolute z-score greater than 1.96 in postoperative testing or a decrease in the postoperative DSST value by more than 20% relative to the preoperative value will be considered the occurrence of POCD in the postoperative period.
Measured: 5 days
Postoperative inflammation measured by serum CRP levels
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels of CRP at postoperative day 1, 3 and 5. CRP > 50 mg/L and rising dynamic of CRP in postoperative serial measurements will be considered as systemic inflammation state.
Measured: 5 days
Postoperative inflammation measured by white blood cells count
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels of white blood cells. Leukocytes > 12.000/mm3 or < 4.000/mm3 in postoperative serial measurements will be considered as systemic inflammation state.
Measured: 5 days
Postoperative inflammation measured by serum IL-6 levels
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels IL-6 at postoperative day 1, 3 and 5. Continuous increase of IL-6 in postoperative serial measurements will be considered as systemic inflammation state.
Measured: 5 days
Postoperative inflammation measured by serum cholinesterase activity
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum cholinesterase activity at postoperative day 1, 3 and 5. Cholinesterase activity < 4000 U/L in postoperative serial measurements will be considered as systemic inflammation state.
Measured: 5 days
Postoperative inflammation measured by serum PCT levels
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels of PCT at postoperative day 1, 3 and 5. PCT > 0.5 ng/ml and continuous increase in postoperative serial measurements will be considered as systemic inflammation state.
Measured: 5 days
Secondary outcomes (1)
Postoperative pain
Postoperative pain with respect to intraoperative sedation will be examined by Numeric rating scale (NRS) 4, 8, 12 and 24 hours after surgery. NRS is a scale from 0 to 10, where 0 means no pain and 10 means the strongest pain. NRS above or equal to 4 will be considered inadequate postoperative analgesia.
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 posted1 Jun 2022
- Study start1 Jul 2022
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Why it stopped: Too long recruitment period due to small number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Josip Juraj Strossmayer University of Osijek
- Responsible party
- Sponsor
- Investigators
- Nenad Neskovic, PhD, Principal investigator, University Hospital Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398757
- Sponsor's protocol ID
- OsijekPOCD
- Acronym
- ProDex-POCD
- Status last verified
- Sep 2024
- First submitted
- 19 Apr 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Monk TG, Price CC. Postoperative cognitive disorders. Curr Opin Crit Care. 2011 Aug;17(4):376-81. doi: 10.1097/MCC.0b013e328348bece.
PubMed 21716111Urits I, Orhurhu V, Jones M, Hoyt D, Seats A, Viswanath O. Current Perspectives on Postoperative Cognitive Dysfunction in the Ageing Population. Turk J Anaesthesiol Reanim. 2019 Dec;47(6):439-447. doi: 10.5152/TJAR.2019.75299. Epub 2019 Sep 2.
PubMed 31828240Xiao QX, Liu Q, Deng R, Gao ZW, Zhang Y. Postoperative cognitive dysfunction in elderly patients undergoing hip arthroplasty. Psychogeriatrics. 2020 Jul;20(4):501-509. doi: 10.1111/psyg.12516. Epub 2020 Jan 24.
PubMed 31976614Rasmussen LS, Larsen K, Houx P, Skovgaard LT, Hanning CD, Moller JT; ISPOCD group. The International Study of Postoperative Cognitive Dysfunction. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89. doi: 10.1034/j.1399-6576.2001.045003275.x.
PubMed 11207462Tombaugh TN, McIntyre NJ. The mini-mental state examination: a comprehensive review. J Am Geriatr Soc. 1992 Sep;40(9):922-35. doi: 10.1111/j.1532-5415.1992.tb01992.x.
PubMed 1512391van Sinderen K, Schwarte LA, Schober P. Diagnostic Criteria of Postoperative Cognitive Dysfunction: A Focused Systematic Review. Anesthesiol Res Pract. 2020 Nov 16;2020:7384394. doi: 10.1155/2020/7384394. eCollection 2020.
PubMed 33281900Wang K, Wu M, Xu J, Wu C, Zhang B, Wang G, Ma D. Effects of dexmedetomidine on perioperative stress, inflammation, and immune function: systematic review and meta-analysis. Br J Anaesth. 2019 Dec;123(6):777-794. doi: 10.1016/j.bja.2019.07.027. Epub 2019 Oct 24.
PubMed 31668347Mei B, Li J, Zuo Z. Dexmedetomidine attenuates sepsis-associated inflammation and encephalopathy via central alpha2A adrenoceptor. Brain Behav Immun. 2021 Jan;91:296-314. doi: 10.1016/j.bbi.2020.10.008. Epub 2020 Oct 8.
PubMed 33039659Hohener D, Blumenthal S, Borgeat A. Sedation and regional anaesthesia in the adult patient. Br J Anaesth. 2008 Jan;100(1):8-16. doi: 10.1093/bja/aem342.
PubMed 18070783Tobias JD, Leder M. Procedural sedation: A review of sedative agents, monitoring, and management of complications. Saudi J Anaesth. 2011 Oct;5(4):395-410. doi: 10.4103/1658-354X.87270.
PubMed 22144928Chen RM, Chen TG, Chen TL, Lin LL, Chang CC, Chang HC, Wu CH. Anti-inflammatory and antioxidative effects of propofol on lipopolysaccharide-activated macrophages. Ann N Y Acad Sci. 2005 May;1042:262-71. doi: 10.1196/annals.1338.030.
PubMed 15965071Kochiyama T, Li X, Nakayama H, Kage M, Yamane Y, Takamori K, Iwabuchi K, Inada E. Effect of Propofol on the Production of Inflammatory Cytokines by Human Polarized Macrophages. Mediators Inflamm. 2019 Mar 17;2019:1919538. doi: 10.1155/2019/1919538. eCollection 2019.
PubMed 31007601
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Administration of Dexmedetomidine, Propofol and Midazolam on Postoperative Levels of Inflammatory Markers and Development of Postoperative Cognitive Dysfunction After Pertrochanteric Fracture Surgery.
- ClinicalTrials.gov ID
- NCT05398757
- Acronym / sponsor ID
- ProDex-POCD / OsijekPOCD
- Keywords
- Postoperative Cognitive Dysfunction, Postoperative pain, Pertrochanteric Fracture, IL-6, Dexmedetomidin, Propofol, Midazolam, Sedation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Too long recruitment period due to small number of patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Collaborators
- Josip Juraj Strossmayer University of Osijek
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 1 Jun 2022 (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.
This study will examine the effect of intraoperative sedation with midazolam, propofol and dexemdetomidine on the occurrence of postoperative cognitive impairment in patients undergoing surgical treatment of pertrochanteric fracture of the femur.
Detailed description
Patients undergoing surgical treatment of pertrochanteric femoral fracture by intramedullary fixation will be included in the study. Patients will be older than 65 years and will belong to class I to III anesthesia risk according to the ASA classification. All patients included in the study will sign informed consent. Patients with dementia, mental illness, psychoorganically altered patients, and patients with a contraindication to dexmedetomidine, propofol, midazolam or with a contraindication to spinal anesthesia will be excluded from the study. All patients included in the study will have their blood taken for laboratory analysis of red blood cells, leukocytes, CRP, PCT, ChE and IL-6. Analyzes will be performed before the procedure, on the 1st, 3rd and 5th postoperative day. All patients will be tested for Mini mental state exame (MMSE) score before surgery to rule out pre-existing cognitive impairment, and those patients who have an MMSE value <17 prior to surgery will be excluded from the study. In premedication, patients will be randomized using three envelopes selected by the blind researcher for the contents of each envelope. According to envelope patients will be divided into three groups: dexmedetomidine group (DS), propofol group (PS) and midazolam group (MS). Neuroaxial spinal block with intrathecal administration of 12.5 - 15 mg 0.5% levobupivacaine in the intervertebral space L3 / L4 or L4 / L5 will be the technique of anesthesia. After spinal block, patients in the DS group will receive a continuous infusion of dexmedetomidine at a dose of 0.5 mcg / kg / h, patients in the PS group will receive a continuous infusion of propofol at a dose of 25-75 mcg / kg / min, while patients in the MS group will receive 0.05-0.07 mg / kg bolus i.v. midazolam. The total dose administered and the duration of surgery will be recorded. The volume of intraoperatively administered crystalloids or blood products will be recorded in all patients included in the study. In the postoperative period, pain will be measured with a numerical rating scale (NRS) 4, 8, 12 and 24 hours after surgery. All patients will receive the usual postoperative analgesia with metamizole and tramadol according to the protocol of the Department. On the 1st, 3rd and 5th postoperative days in the morning between 8.00 and 10.00, all patients will be tested for MMSE and Digit Symbol Substitution Test (DSST) score. A researcher who will evaluate MMSE and DSST values in the postoperative period will be blind to the drug that patients received intraoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Midazolam | Other | Behavioral: Mini mental state exame (MMSE), Behavioral: Digit Symbol Substitution Test (DSST), Diagnostic Test: Numeric rating Scale (NRS), Diagnostic Test: Postoperative inflammation, Drug: MidazolamFor sedation during surgery, patients will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg. |
| Propofol | Active comparator | Behavioral: Mini mental state exame (MMSE), Behavioral: Digit Symbol Substitution Test (DSST), Diagnostic Test: Numeric rating Scale (NRS), Diagnostic Test: Postoperative inflammation, Drug: PropofolFor sedation during surgery, patients will receive i.v. propofol in dose 25-27 mcg/kg/min. |
| Dexmedetomidin | Active comparator | Behavioral: Mini mental state exame (MMSE), Behavioral: Digit Symbol Substitution Test (DSST), Diagnostic Test: Numeric rating Scale (NRS), Diagnostic Test: Postoperative inflammation, Drug: DexmedetomidinFor sedation during surgery, patients will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Pertrochanteric fracture surgery
- Informed consent signed
Key exclusion criteria (3 listed)
- MMSE before surgery < 17
- Allergy on midazolam, propofol or dexemdetomidine
- Contraindication for neuroaxial anesthesia
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 |
|---|---|---|
| Mini mental state exame (MMSE)Before the operation, and on the 1st, 3rd and 5th day after the operation, the Mini mental state exam (MMSE) score will be measured | Behavioural | Dexmedetomidin, Midazolam, Propofol |
| Digit Symbol Substitution Test (DSST)Before the operation, and on the 1st, 3rd and 5th day after the operation, the Digit Symbol Substitution Test (DSST) score will be measured | Behavioural | Dexmedetomidin, Midazolam, Propofol |
| Numeric rating Scale (NRS)4h, 8h, 12h and 24h after surgery, pain in all patients will be assessed by the NRS scale. | Diagnostic test | Dexmedetomidin, Midazolam, Propofol |
| Postoperative inflammationAll patients included in the study will have their blood taken for laboratory analysis of red blood cells, leukocytes, CRP, PCT, ChE and IL-6. Analyzes will be performed before the procedure, on the 1st, 3rd and 5th postoperative day. | Diagnostic test | Dexmedetomidin, Midazolam, Propofol |
| MidazolamAlso: Control - group MFor sedation during surgery, patients in midazolam group will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg after spinal anesthesia. | Drug | Midazolam |
| PropofolAlso: Group PFor sedation during surgery, patients in propofol group will receive i.v. propofol in dose 25-27 mcg/kg/min. | Drug | Propofol |
| DexmedetomidinAlso: Group DFor sedation during surgery, patients in dexmedetomidin gropu will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h | Drug | Dexmedetomidin |
Primary outcome
Occurrence of postoperative cognitive dysfunction (POCD) measured by MMSE
Time frame: 5 days
The incidence of POCD with respect to intraoperative sedation in the postoperative period will be measured by MMSE test on the first, third and fifth postoperative day. An absolute z-score greater than 1.96 in postoperative testing or a decrease in the postoperative MMSE value by more than 20% relative to the preoperative value will be considered the occurrence of POCD in the postoperative period.
Occurrence of postoperative cognitive dysfunction (POCD) measured by DSST
Time frame: 5 days
The incidence of POCD with respect to intraoperative sedation in the postoperative period will be measured by DSST on the first, third and fifth postoperative day. An absolute z-score greater than 1.96 in postoperative testing or a decrease in the postoperative DSST value by more than 20% relative to the preoperative value will be considered the occurrence of POCD in the postoperative period.
Postoperative inflammation measured by serum CRP levels
Time frame: 5 days
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels of CRP at postoperative day 1, 3 and 5. CRP > 50 mg/L and rising dynamic of CRP in postoperative serial measurements will be considered as systemic inflammation state.
Postoperative inflammation measured by white blood cells count
Time frame: 5 days
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels of white blood cells. Leukocytes > 12.000/mm3 or < 4.000/mm3 in postoperative serial measurements will be considered as systemic inflammation state.
Postoperative inflammation measured by serum IL-6 levels
Time frame: 5 days
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels IL-6 at postoperative day 1, 3 and 5. Continuous increase of IL-6 in postoperative serial measurements will be considered as systemic inflammation state.
Postoperative inflammation measured by serum cholinesterase activity
Time frame: 5 days
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum cholinesterase activity at postoperative day 1, 3 and 5. Cholinesterase activity < 4000 U/L in postoperative serial measurements will be considered as systemic inflammation state.
Postoperative inflammation measured by serum PCT levels
Time frame: 5 days
Postoperative inflammation with respect to intraoperative sedation will be assessed by serum levels of PCT at postoperative day 1, 3 and 5. PCT > 0.5 ng/ml and continuous increase in postoperative serial measurements will be considered as systemic inflammation state.
1 secondary outcome
Postoperative pain
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 21716111Monk TG, Price CC. Postoperative cognitive disorders. Curr Opin Crit Care. 2011 Aug;17(4):376-81. doi: 10.1097/MCC.0b013e328348bece.
- Background: PubMed 31828240Urits I, Orhurhu V, Jones M, Hoyt D, Seats A, Viswanath O. Current Perspectives on Postoperative Cognitive Dysfunction in the Ageing Population. Turk J Anaesthesiol Reanim. 2019 Dec;47(6):439-447. doi: 10.5152/TJAR.2019.75299. Epub 2019 Sep 2.
- Background: PubMed 31976614Xiao QX, Liu Q, Deng R, Gao ZW, Zhang Y. Postoperative cognitive dysfunction in elderly patients undergoing hip arthroplasty. Psychogeriatrics. 2020 Jul;20(4):501-509. doi: 10.1111/psyg.12516. Epub 2020 Jan 24.
- Background: PubMed 11207462Rasmussen LS, Larsen K, Houx P, Skovgaard LT, Hanning CD, Moller JT; ISPOCD group. The International Study of Postoperative Cognitive Dysfunction. The assessment of postoperative cognitive function. Acta Anaesthesiol Scand. 2001 Mar;45(3):275-89. doi: 10.1034/j.1399-6576.2001.045003275.x.
- Background: PubMed 1512391Tombaugh TN, McIntyre NJ. The mini-mental state examination: a comprehensive review. J Am Geriatr Soc. 1992 Sep;40(9):922-35. doi: 10.1111/j.1532-5415.1992.tb01992.x.
- Background: PubMed 33281900van Sinderen K, Schwarte LA, Schober P. Diagnostic Criteria of Postoperative Cognitive Dysfunction: A Focused Systematic Review. Anesthesiol Res Pract. 2020 Nov 16;2020:7384394. doi: 10.1155/2020/7384394. eCollection 2020.
- Background: PubMed 31668347Wang K, Wu M, Xu J, Wu C, Zhang B, Wang G, Ma D. Effects of dexmedetomidine on perioperative stress, inflammation, and immune function: systematic review and meta-analysis. Br J Anaesth. 2019 Dec;123(6):777-794. doi: 10.1016/j.bja.2019.07.027. Epub 2019 Oct 24.
- Background: PubMed 33039659Mei B, Li J, Zuo Z. Dexmedetomidine attenuates sepsis-associated inflammation and encephalopathy via central alpha2A adrenoceptor. Brain Behav Immun. 2021 Jan;91:296-314. doi: 10.1016/j.bbi.2020.10.008. Epub 2020 Oct 8.
- Background: PubMed 18070783Hohener D, Blumenthal S, Borgeat A. Sedation and regional anaesthesia in the adult patient. Br J Anaesth. 2008 Jan;100(1):8-16. doi: 10.1093/bja/aem342.
- Background: PubMed 22144928Tobias JD, Leder M. Procedural sedation: A review of sedative agents, monitoring, and management of complications. Saudi J Anaesth. 2011 Oct;5(4):395-410. doi: 10.4103/1658-354X.87270.
- Background: PubMed 15965071Chen RM, Chen TG, Chen TL, Lin LL, Chang CC, Chang HC, Wu CH. Anti-inflammatory and antioxidative effects of propofol on lipopolysaccharide-activated macrophages. Ann N Y Acad Sci. 2005 May;1042:262-71. doi: 10.1196/annals.1338.030.
- Background: PubMed 31007601Kochiyama T, Li X, Nakayama H, Kage M, Yamane Y, Takamori K, Iwabuchi K, Inada E. Effect of Propofol on the Production of Inflammatory Cytokines by Human Polarized Macrophages. Mediators Inflamm. 2019 Mar 17;2019:1919538. doi: 10.1155/2019/1919538. eCollection 2019.
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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.
Nenad Neskovic, PhD principal investigator
University Hospital Osijek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini mental state exame (MMSE), Digit Symbol Substitution Test (DSST) and Numeric rating Scale (NRS) in people with Postoperative Cognitive Dysfunction and Postoperative Pain, Acute, run by Osijek University Hospital at 1 site in Croatia.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 Sep 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 Croatia. 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 was withdrawn before enrolling participants, so there are no results.
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?
Occurrence of postoperative cognitive dysfunction (POCD) measured by MMSE (time frame: 5 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05398757, which also lists 12 linked publications.
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 19 Sep 2024.