The Effect of Spinal Anesthesia on Hemodynamics

Not Applicable

Completed

• Conditions: Anesthesia, Spinal
• Interventions: Other: 7.5 mg hyperbaric bupivacaine; Other: 5 mg hyperbaric bupivacaine

• Registration Number: NCT05896631
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

In this study, it was planned to provide more stable hemodynamics in geriatric patients with low-dose spinal anesthesia. We will compare 7.5mg hyperbaric bupivacaine with 5mg hyperbaric bupivacaine.

The researchers hypothesized that low-dose bupivacaine would provide adequate anesthesia, less hypotension, and faster recovery.

Detailed Description

Hypothesis It is hypothesized that low-dose bupivacaine can provide adequate anesthesia, less hypotension, and faster recovery.

patient population Patients over 65 years of age who will undergo spinal anesthesia due to hip fracture.

Hemodynamic data(Blood pressure-mmHg, heart rate-beats per minute) of patients, bromage scores, perfusion index (PI) values, discharge time, pain with NRS (numerical rating scale), patient satisfaction will be evaluated ( Numeric output from 1-10).

Hemodynamic variables will be recorded every 2 minutes in the first 20 minutes after spinal anesthesia. hemodynamic variables will be recorded 30 minutes after spinal anesthesia and at the end of the operation.

The perfusion index is the ratio of the blood volume to the pulsatile to non-pulsatile fraction. An increase in the pulsatile fraction that occurs during vasodilation corresponds to a higher PI. Therefore, patients with a higher PI have a higher risk of post-spinal hypotension.

Study Timeline

• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-31
• Study Start: 2023-06-08
• Study First Posted: 2023-06-09
• Primary Completion: 2023-09-01
• Study Completion: 2023-10-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• ASA(American Society of Anesthesiologists) I-II-III patients
• BMI( body mass index) in the range of 18-40
• over 65 years old hip fracture

Exclusion Criteria

• Refusal to participate in the study
• Left ventricular ejection fraction below 40%
• cardiac arrhythmia
• Patients with peripheral vascular disease
• Failure of spinal anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7.5 mg hyperbaric bupivacaine	7.5 mg hyperbaric bupivacaine	Patients undergoing spinal anesthesia in the lateral decubitus position with 7.5 mg of hyperbaric bupivacaine will be included.
5 mg hyperbaric bupivacaine	5 mg hyperbaric bupivacaine	Patients undergoing spinal anesthesia in the lateral decubitus position with 5 mg of hyperbaric bupivacaine will be included.

Primary Outcome Measures

Name	Time	Method
hemodynamic variability	at 30 minutes of spinal anesthesia	intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery

Secondary Outcome Measures

Name	Time	Method
Sensory Levels	24 hours	Sensory levels will be measured every 30 minutes until discharge from PACU(post-anaesthesia care unit)
ephedrine use	24 hours	ephedrine consumption , mg in hip surgery
fentanyl use	24 hours	fentanyl consumption , mcg in hip surgery
bromage scale	24 hours	Bromage Scores every 30 minutes until discharge from PACU(post-anaesthesia care unit).
perfusion index variability	at the end of the operation	To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery
NRS(numerical rating scale)	24 hours	pain scoring a score of 1 to 10

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Çankaya, Turkey