NCT05896631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

June 8, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

May 22, 2023

Last Update Submit

July 22, 2024

Conditions

Anesthesia, Spinal

Keywords

hemodynamic managementspinal anesthesiageriatric anesthesia

Outcome Measures

Primary Outcomes (2)

  • hemodynamic variability

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

    every 2 minutes for the first 20 minutes after spinal anesthesia

  • hemodynamic variability

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

    at 30 minutes of spinal anesthesia

Secondary Outcomes (11)

  • perfusion index variability

    every 2 minutes for the first 20 minutes after spinal anesthesia

  • perfusion index variability

    at 30 minutes of spinal anesthesia

  • perfusion index variability

    at the end of the operation

  • Sensory Levels

    24 hours

  • ephedrine use

    24 hours

  • +6 more secondary outcomes

Study Arms (2)

7.5 mg hyperbaric bupivacaine

ACTIVE COMPARATOR

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

5 mg hyperbaric bupivacaine

ACTIVE COMPARATOR

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

Other: 5 mg hyperbaric bupivacaine

Interventions

7.5 mg hyperbaric bupivacaineOTHER

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

7.5 mg hyperbaric bupivacaine
5 mg hyperbaric bupivacaineOTHER

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

5 mg hyperbaric bupivacaine

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and reanimation assistant doktor

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 9, 2023

Study Start

June 8, 2023

Primary Completion

September 1, 2023

Study Completion

October 1, 2023

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)