Effect of hyperbaric or isobaric bupivacaine on spinal block and on cardiac function in elderly patients undergoing transurethral procedures - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003649-10-IT

Enrollment

Registered

2008-07-30

Start date

2009-09-29

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

spinal block and on cardiac function in elderly patients undergoing transurethral procedures MedDRA version: 9.1 Level: HLT Classification code 10002092 Term: Anaesthesia and allied procedures

Interventions

Trade Name: MARCAINA Pharmaceutical Form: Solution for injection INN or Proposed INN: Bupivacaine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5-

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: male patients over 70 years of age ASA I-II-III undergoing bladder transurethral resection. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: patients with previous myocardial infarct, patients with angina pectoris, valvular diseases, sepsi, coagulopathy, allergy to local anaesthetics, infection at site of injection.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to compare onset time, duration time and level of sensitive and motor block;Secondary Objective: effect on cardiac function during subarachnoidal anaesthesia with hyperbaric and isobaric bupivacaine.;Primary end point(s): scala analogica visuale scala bromage Prinprick ecocardiografia	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026