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NCT Number: NCT05896631

The Effect of Spinal Anesthesia on Hemodynamics

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.

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Key information

Conditions

Anesthesia, Spinal

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

7.5 mg hyperbaric bupivacaine

Other

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

5 mg hyperbaric bupivacaine

Other

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

Primary outcomes

  1. hemodynamic variability

    Time frame: every 2 minutes for the first 20 minutes after spinal anesthesia

    intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery

  2. hemodynamic variability

    Time frame: at 30 minutes of spinal anesthesia

    intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery

Secondary outcomes

  1. perfusion index variability

    Time frame: every 2 minutes for the first 20 minutes after spinal anesthesia

    To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery

  2. perfusion index variability

    Time frame: at 30 minutes of spinal anesthesia

    To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery

  3. perfusion index variability

    Time frame: at the end of the operation

    To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery

  4. Sensory Levels

    Time frame: 24 hours

    Sensory levels will be measured every 30 minutes until discharge from PACU(post-anaesthesia care unit)

  5. ephedrine use

    Time frame: 24 hours

    ephedrine consumption , mg in hip surgery

  6. fentanyl use

    Time frame: 24 hours

    fentanyl consumption , mcg in hip surgery

  7. bromage scale

    Time frame: 24 hours

    Bromage Scores every 30 minutes until discharge from PACU(post-anaesthesia care unit).

  8. NRS(numerical rating scale)

    Time frame: 2 hours

    pain scoring a score of 1 to 10

  9. NRS(numerical rating scale)

    Time frame: 8 hours

    pain scoring a score of 1 to 10

  10. NRS(numerical rating scale)

    Time frame: 16 hours

    pain scoring a score of 1 to 10

  11. NRS(numerical rating scale)

    Time frame: 24 hours

    pain scoring a score of 1 to 10

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2023
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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