The Effect of Spinal Anesthesia on Hemodynamics

Anesthesia, Spinal Clinical Trial

Official title:

The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05896631
• Other study ID #: geriatrics
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: September 25, 2023

Study information

• Verified date: May 2023
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 25, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Spinal

Intervention

Other:
• 7.5 mg hyperbaric bupivacaine
Spinal anesthesia with 7.5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block
• 5 mg hyperbaric bupivacaine
Spinal anesthesia with 5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemodynamic variability	intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery	every 2 minutes for the first 20 minutes after spinal anesthesia
Primary	hemodynamic variability	intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery	at 30 minutes of spinal anesthesia
Secondary	perfusion index variability	To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery	every 2 minutes for the first 20 minutes after spinal anesthesia
Secondary	perfusion index variability	To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery	at 30 minutes of spinal anesthesia
Secondary	perfusion index variability	To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery	at the end of the operation
Secondary	Sensory Levels	Sensory levels will be measured every 30 minutes until discharge from PACU(post-anaesthesia care unit)	24 hours
Secondary	ephedrine use	ephedrine consumption , mg in hip surgery	24 hours
Secondary	fentanyl use	fentanyl consumption , mcg in hip surgery	24 hours
Secondary	bromage scale	Bromage Scores every 30 minutes until discharge from PACU(post-anaesthesia care unit).	24 hours
Secondary	NRS(numerical rating scale)	pain scoring a score of 1 to 10	2 hours
Secondary	NRS(numerical rating scale)	pain scoring a score of 1 to 10	8 hours
Secondary	NRS(numerical rating scale)	pain scoring a score of 1 to 10	16 hours
Secondary	NRS(numerical rating scale)	pain scoring a score of 1 to 10	24 hours