Propofol and Dexmedetomidin vs Midazolam Intraoperative Sedation and POCD

NCT ID: NCT05398757

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-03-01

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.

Conditions

Postoperative Cognitive Dysfunction; Postoperative Pain, Acute; Pertrochanteric Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Midazolam

For sedation during surgery, patients will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg.

Group Type: OTHER

Mini mental state exame (MMSE)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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)

Intervention Type: DIAGNOSTIC_TEST

4h, 8h, 12h and 24h after surgery, pain in all patients will be assessed by the NRS scale.

Postoperative inflammation

Intervention Type: DIAGNOSTIC_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.

Midazolam

Intervention Type: DRUG

For sedation during surgery, patients in midazolam group will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg after spinal anesthesia.

Propofol

For sedation during surgery, patients will receive i.v. propofol in dose 25-27 mcg/kg/min.

Group Type: ACTIVE_COMPARATOR

Mini mental state exame (MMSE)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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)

Intervention Type: DIAGNOSTIC_TEST

4h, 8h, 12h and 24h after surgery, pain in all patients will be assessed by the NRS scale.

Postoperative inflammation

Intervention Type: DIAGNOSTIC_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.

Propofol

Intervention Type: DRUG

For sedation during surgery, patients in propofol group will receive i.v. propofol in dose 25-27 mcg/kg/min.

Dexmedetomidin

For sedation during surgery, patients will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h

Group Type: ACTIVE_COMPARATOR

Mini mental state exame (MMSE)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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)

Intervention Type: DIAGNOSTIC_TEST

4h, 8h, 12h and 24h after surgery, pain in all patients will be assessed by the NRS scale.

Postoperative inflammation

Intervention Type: DIAGNOSTIC_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.

Dexmedetomidin

Intervention Type: DRUG

For sedation during surgery, patients in dexmedetomidin gropu will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h

Interventions

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Numeric rating Scale (NRS)

4h, 8h, 12h and 24h after surgery, pain in all patients will be assessed by the NRS scale.

Intervention Type: DIAGNOSTIC_TEST

Postoperative inflammation

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.

Intervention Type: DIAGNOSTIC_TEST

Midazolam

For sedation during surgery, patients in midazolam group will receive i.v. midazolam in dose 0.05 - 0.07 mg/kg after spinal anesthesia.

Intervention Type: DRUG

Propofol

For sedation during surgery, patients in propofol group will receive i.v. propofol in dose 25-27 mcg/kg/min.

Intervention Type: DRUG

Dexmedetomidin

For sedation during surgery, patients in dexmedetomidin gropu will receive i.v. dexmedetomidin in dose 0.5 mcg/kg/h

Intervention Type: DRUG

Other Intervention Names

Control - group M; Group P; Group D

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Josip Juraj Strossmayer University of Osijek

OTHER

Sponsor Role: collaborator

Osijek University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nenad Neskovic, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Osijek

Locations

University Hospital Osijek

Osijek, , Croatia

Countries

Croatia

References

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Other Identifiers

OsijekPOCD

Identifier Type: -

Identifier Source: org_study_id