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NCT Number: NCT06972485

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskişehir Osmangazi University

Eskişehir, Odunpazari, 26040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Spinal anesthesia

Procedure

spinal anesthesia with hypobaric and hyperbaric bupivacaine

Primary outcomes

  1. Hemodynamic effects of hypobaric and hyperbaric bupivacaine with spinal anesthesia

    Time frame: 2 hour

    blood pressure monitoring

Secondary outcomes

  1. Evaluation of sensorial block with hypobaric and hyperbaric bupivacaine in spinal anesthesia

    Time frame: 2 hour

    sensorial block evaluate with pinprick test; sensorial block level; present/absent

  2. Evaluation of motor block with hypobaric and hyperbaric bupivacaine in spinal anesthesia

    Time frame: 2 hour

    motor block evaluate with bromage scale ;Grade 0: Full movement of hips, knees, and ankles (no block). Grade 1: Unable to lift the leg but can move knees and ankles (partial block). Grade 2: Unable to bend the knee but can move ankles (near-complete block). Grade 3: No movement in hips, knees, or ankles (complete block).

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 15, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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