NCT05868642

Brief Summary

Studying the hemodynamic effects of titrated subarachnoid anesthesia versus conventional single-shot subarachnoid anesthesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration 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 13, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 25, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

May 13, 2018

Last Update Submit

May 11, 2023

Conditions

Anesthesia; Adverse EffectAnesthesia, Local

Outcome Measures

Primary Outcomes (1)

  • SBP change

    SBP will be recorded at baseline and every 5 minutes after the subarachnoid block for 1 hour

    60 minute

Study Arms (2)

T group

EXPERIMENTAL

Subaracnhoid block levobupivacaine 0.5%, 10 mg (2 ml) via subarachnoid injection plus 1mg for each metameric level needed to achieve the T10 level sensory block (evaluation with pinprick test at 10 minute after the firts injection and at 4 minute from the second injection)

Procedure: subarachnoid block

S group

ACTIVE COMPARATOR

levobupivacaine 0.5%, 15 mg (3 ml) via subarachnoid injection

Procedure: subarachnoid block

Interventions

subarachnoid blockPROCEDURE

subarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty

S groupT group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • BMI 20-40 kg/m2
  • ASA 1-3
  • undergoing total hip arthroplasty
  • no controindications to subaracnhoid block
  • able to understand and sign a written informed consensus
  • METs \> o = 4

You may not qualify if:

  • baseline SBP \< 100 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • battista borghi, professor

    isituto ortopedico rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2018

First Posted

May 22, 2023

Study Start

June 25, 2018

Primary Completion

May 25, 2020

Study Completion

June 25, 2020

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations

IT(1)