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CompletedNCT06972485Updated Jan 5, 2026

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

An interventional study of spinal anesthesia in Geriatric Patient, Spinal Anesthesia and Hip Surgery, sponsored by Eskisehir Osmangazi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

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.

Read the detailed 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.

02

Conditions studied

  • Geriatric Patient
  • Spinal Anesthesia
  • Hip Surgery

Keywords

  • Geriatric patient
  • Hemodynamic changes
  • Hypobaric bupivacaine
  • hyperbaric bupivacaine
03

In context

Lead sponsor

Eskisehir Osmangazi University is the lead sponsor of 149 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    HypoB

    In the HypoB group, spinal anesthesia will be administered intrathecally using 3 cc of hypobaric bupivacaine solution in the lateral decubitus position, with the fractured side positioned upward.The patients will then be kept in the lateral position for 15 minutes. The patients' hemodynamic data , bilateral sensory and motor block levels will be recorded.

    Procedure: spinal anesthesia

  • Active comparator
    HyperB

    In the HyperB group, spinal anesthesia will be administered intrathecally using 3 cc of hyperbaric bupivacaine solution in the lateral decubitus position, with the fractured side positioned downward.The patients will then be kept in the lateral position for 15 minutes. The patients' hemodynamic data, bilateral sensory, and motor block levels will be recorded.

    Procedure: spinal anesthesia

Interventions

  • Procedurespinal anesthesia

    spinal anesthesia with hypobaric and hyperbaric bupivacaine

06

What researchers measure

Primary outcomes

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

    blood pressure monitoring

    Time frame: 2 hour

Secondary outcomes

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

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

    Time frame: 2 hour

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

    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).

    Time frame: 2 hour

07

Study locations

1 site
  • Eskişehir Osmangazi University
    Eskişehir, Odunpazari 26040, Turkey (Türkiye)
08

References and documents

Publications

  • Herrera R, De Andres J, Estan L, Olivas FJ, Martinez-Mir I, Steinfeldt T. Hemodynamic impact of isobaric levobupivacaine versus hyperbaric bupivacaine for subarachnoid anesthesia in patients aged 65 and older undergoing hip surgery. BMC Anesthesiol. 2014 Oct 24;14:97. doi: 10.1186/1471-2253-14-97. eCollection 2014. PubMed 25371654 ↗
  • Uppal V, Retter S, Shanthanna H, Prabhakar C, McKeen DM. Hyperbaric Versus Isobaric Bupivacaine for Spinal Anesthesia: Systematic Review and Meta-analysis for Adult Patients Undergoing Noncesarean Delivery Surgery. Anesth Analg. 2017 Nov;125(5):1627-1637. doi: 10.1213/ANE.0000000000002254. PubMed 28708665 ↗
  • Gong C, Ye X, Liao Y, Ye P, Zheng T, Zheng X. Hypotension after unilateral versus bilateral spinal anaesthesia: A Systematic review with meta-analysis. Eur J Anaesthesiol. 2025 Mar 1;42(3):203-223. doi: 10.1097/EJA.0000000000002098. Epub 2024 Nov 21. PubMed 39575900 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06972485
Lead sponsor
Eskisehir Osmangazi University
Responsible party
Fadime Alagaş (Research assistant, Eskisehir Osmangazi University) — Principal investigator
First posted
May 15, 2025
Start date
May 15, 2025
Primary completion
Dec 27, 2025
Completion
Dec 30, 2025
Last update
Jan 5, 2026

Study contacts

Sacit Güleç, Professor
study director · Eskisehir Osmangazi University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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