Clinical trial NCT06972485: Comparison of Hemodynamic Effects of Hypobaric and Hyperbaric Bupivacaine in Spinal Anesthesia in Geriatric Patients
Official title: Comparison of Hemodynamic Effects of Hypobaric and Hyperbaric Bupivacaine in Spinal Anesthesia During Hip Surgery in Geriatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Geriatric Patient
Spinal Anesthesia
Hip Surgery
Keywords: Geriatric patient
Hemodynamic changes
Hypobaric bupivacaine
hyperbaric bupivacaine
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention will be performed in geriatric patients of hemodynamic changes (hypotension, bradycardia) associated with spinal anesthesia
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemodynamic effects of hypobaric and hyperbaric bupivacaine with spinal anesthesia
timeFrame: 2 hour
Secondary outcomes:
measure: Evaluation of sensorial block with hypobaric and hyperbaric bupivacaine in spinal anesthesia
timeFrame: 2 hour
measure: Evaluation of motor block with hypobaric and hyperbaric bupivacaine in spinal anesthesia
timeFrame: 2 hour
Other outcomes:
Locations:
city: Eski̇şehi̇r
country: Turkey
facility: Eskişehir Osmangazi University
state: Odunpazari
Study officials:
affiliation: Eskisehir Osmangazi University
name: Sacit Güleç, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.