Clinical trial NCT05398757: Propofol and Dexmedetomidin vs Midazolam Intraoperative Sedation and POCD
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Postoperative Pain, Acute
Pertrochanteric Fracture
Keywords: Postoperative Cognitive Dysfunction
Postoperative pain
Pertrochanteric Fracture
IL-6
Dexmedetomidin
Propofol
Midazolam
Sedation
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
Collaborators: name: Josip Juraj Strossmayer University of Osijek
First posted: 2022-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Pertrochanteric fracture surgery
* Informed consent signed

Exclusion Criteria:

* MMSE before surgery \< 17
* Allergy on midazolam, propofol or dexemdetomidine
* Contraindication for neuroaxial anesthesia

Primary outcomes:
measure: Occurrence of postoperative cognitive dysfunction (POCD) measured by MMSE
timeFrame: 5 days
measure: Occurrence of postoperative cognitive dysfunction (POCD) measured by DSST
timeFrame: 5 days
measure: Postoperative inflammation measured by serum CRP levels
timeFrame: 5 days
measure: Postoperative inflammation measured by white blood cells count
timeFrame: 5 days
measure: Postoperative inflammation measured by serum IL-6 levels
timeFrame: 5 days
measure: Postoperative inflammation measured by serum cholinesterase activity
timeFrame: 5 days
measure: Postoperative inflammation measured by serum PCT levels
timeFrame: 5 days
Secondary outcomes:
measure: Postoperative pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: University Hospital Osijek
Study officials:
affiliation: University Hospital Osijek
name: Nenad Neskovic, PhD
role: PRINCIPAL_INVESTIGATOR
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