Comparison of Hemodynamic Effects of Hypobaric and Hyperbaric Bupivacaine in Spinal Anesthesia in Geriatric Patients

Last updated: May 18, 2025
Sponsor: Eskisehir Osmangazi University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedic Surgery

Anesthesia (Local)

Orthopedics

Treatment

spinal anesthesia

Clinical Study ID

NCT06972485
FALAGAS 1
  • Ages > 65
  • All Genders

Study Summary

The frequency of hypotension is increased in geriatric patients due to physiological changes compared to the normal population. In this study, our aim is to compare the hemodynamic changes in geriatric patients undergoing hip surgery under spinal anesthesia with hypobaric and hyperbaric bupivacaine.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 65 years of age

  • Patients taken to surgery in a supine position due to femur fractures

  • Patients classified as ASA (American Society of Anesthesiologists) class I-III

Exclusion

Exclusion Criteria:

  • History of allergy to the drug

  • Patients with coagulopathy

  • Patients refusing to participate in the study

  • Severe valve stenosis

  • Infection at the injection site

  • Inadequate spinal anesthesia level during surgery

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: spinal anesthesia
Phase:
Study Start date:
May 15, 2025
Estimated Completion Date:
November 10, 2025

Study Description

Patients will be randomly assigned to one of two groups: HypoB (% 0.5 bupivacaine 3cc+ 2cc distilled water) or HyperB (% 0.5 bupivacaine 3cc+ 2cc %10 dextrose). For pre-positioning analgesia, an intravenous dose of fentanyl at 0.5 mcg/kg will be administered. Patients will then be positioned in the appropriate lateral decubitus position based on whether hypobaric or hyperbaric bupivacaine is used. Spinal anesthesia will be performed using 3 cc local anesthetic solution, followed by 15 minutes of lateralization.

During the surgery, hemodynamic parameters, sensory block levels at the 5th, 10th, 15th, and 20th minutes at lateral and supine position, and motor block levels with bromage scale at the 15th and 20th minutes at supine position will be recorded. The spread of the block to the T8 dermatome level was considered an indicator of a successful block. Hemodynamic parameters (blood pressure, heart rate, peripheral oxygen saturation) will be recorded at 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, and 120 minutes intraoperatively. Patients will receive crystalloid infusion at a rate of 5-7 ml/kg per hour throughout the procedure. The volume of intraoperative bleeding, the amount of blood products administered, and the doses of ephedrine, atropine, and noradrenaline used will also be documented. If the heart rate falls below 45 beats per minute, 0.5 mg of intravenous atropine will be administered.

A decrease in blood pressure of 20% or more from baseline will be defined as hypotension. In such cases, ephedrine will be administered. If hypotension persists despite a total dose of 20 mg ephedrine, a noradrenaline infusion will be initiated.

Connect with a study center

  • Eskişehir Osmangazi University

    Eski̇şehi̇r, Odunpazari 26040
    Turkey

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.