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

Eskisehir Osmangazi University

Status: Completed

Conditions: Hip Surgery; Spinal Anesthesia; Geriatric Patient

Treatments: Procedure: spinal anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06972485

FALAGAS 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

HypoB

Active Comparator group

Description:

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.

Treatment:

Procedure: spinal anesthesia

HyperB

Active Comparator group

Description:

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.

Treatment:

Procedure: spinal anesthesia