Propofol and Dexmedetomidin vs Midazolam Intraoperative Sedation and POCD

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.

Conditions

• Postoperative Cognitive Dysfunction
• Postoperative Pain, Acute
• Pertrochanteric Fracture

Interventions

BEHAVIORAL

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

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

DIAGNOSTIC_TEST

Numeric rating Scale (NRS)

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

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.

DRUG

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.

DRUG

Propofol

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

DRUG

Dexmedetomidin

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

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek

  collaborator OTHER

• Osijek University Hospital

  lead OTHER

Principal Investigators

• Nenad Neskovic, PhD · University Hospital Osijek

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2024-03-01

Completion

2024-03-01

Countries

• Croatia

Study Locations