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

NCT06972485 | Completed

• 1 other identifier: FALAGAS 1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Geriatric Patient; Spinal Anesthesia; Hip Surgery

Keywords

Geriatric patient; Hemodynamic changes; Hypobaric bupivacaine; hyperbaric bupivacaine

Outcome Measures

Primary Outcomes (1)

• Hemodynamic effects of hypobaric and hyperbaric bupivacaine with spinal anesthesia

  blood pressure monitoring

  2 hour

Secondary Outcomes (2)

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

  2 hour

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

  2 hour

Study Arms (2)

HypoB

ACTIVE COMPARATOR

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

HyperB

ACTIVE COMPARATOR

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

spinal anesthesia PROCEDURE

spinal anesthesia with hypobaric and hyperbaric bupivacaine

HyperB; HypoB

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskişehir Osmangazi University

Eskişehir, Odunpazari, 26040, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 25371654 BACKGROUND

• 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.

  PMID: 28708665 BACKGROUND

• 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.

  PMID: 39575900 BACKGROUND

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Sacit Güleç, Professor

  Eskisehir Osmangazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: Intervention will be performed in geriatric patients of hemodynamic changes (hypotension, bradycardia) associated with spinal anesthesia

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 15, 2025
• Study Start: May 15, 2025
• Primary Completion: December 27, 2025
• Study Completion: December 30, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-04

Locations

TU (1)