The Effect of Spinal Anesthesia on Hemodynamics

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05896631
Collaborator
(none)
80
1
2
3.6
22.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 7.5 mg hyperbaric bupivacaine
  • Other: 5 mg hyperbaric bupivacaine
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients
Anticipated Study Start Date :
Jun 8, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 25, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 7.5 mg hyperbaric bupivacaine

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

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

Active Comparator: 5 mg hyperbaric bupivacaine

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

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

Outcome Measures

Primary Outcome Measures

  1. hemodynamic variability [every 2 minutes for the first 20 minutes after spinal anesthesia]

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

  2. hemodynamic variability [at 30 minutes of spinal anesthesia]

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

Secondary Outcome Measures

  1. perfusion index variability [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 [at 30 minutes of spinal anesthesia]

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

  3. perfusion index variability [at the end of the operation]

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

  4. Sensory Levels [24 hours]

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

  5. ephedrine use [24 hours]

    ephedrine consumption , mg in hip surgery

  6. fentanyl use [24 hours]

    fentanyl consumption , mcg in hip surgery

  7. bromage scale [24 hours]

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

  8. NRS(numerical rating scale) [2 hours]

    pain scoring a score of 1 to 10

  9. NRS(numerical rating scale) [8 hours]

    pain scoring a score of 1 to 10

  10. NRS(numerical rating scale) [16 hours]

    pain scoring a score of 1 to 10

  11. NRS(numerical rating scale) [24 hours]

    pain scoring a score of 1 to 10

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Bilkent City Hospital Ankara Çankaya Turkey 06800

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatma Kavak Akelma, Anesthesiology and reanimation assistant doktor, Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT05896631
Other Study ID Numbers:
  • geriatrics
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 9, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatma Kavak Akelma, Anesthesiology and reanimation assistant doktor, Ankara City Hospital Bilkent
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2023