Clinical trial

Comparison of Hemodynamic Effect Between the Spinal Anesthesia and Saddle Block Using Levobupivacaine During Transurethral Resection of the Prostate in Cardiac Elderly Patients: A Randomized Clinical Trial

Name

transurethral resection

Description

Transurethral resection of the prostate (TURP) is the most common surgical intervention for patients with benign prostatic hyperplasia. TURP is mostly applied to elderly patients with hypertension and problems with breathing, circulation system, and kidney functions; therefore, it becomes very important to keep a stable anesthesia that will minimize the hemodynamic differences in these patients. General anesthesia causes more hemodynamic differences than regional anesthesia. Thus, regional anesthesia is highly preferable in TURP applications.

Trial arms

Trial start

2023-08-30

Estimated PCD

2023-12-01

Trial end

2023-12-01

Status

Recruiting

Treatment

spinal anesthesia

12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF), immediately positioned supine with one pillow supporting the head and shoulders

Arms:

spinal group

saddle block

12.5 mg of 0.5% hyperbaric levobupivacaine (2.5 ml) was given at the level of L4-5 interspaces after the free flow confirming of the cerebrospinal fluid (CSF), placed in the sitting position for ten minutes and then supine with one pillow supporting the head and shoulders

Arms:

saddle block group

Size

Primary endpoint

mean arterial blood pressure

24 hours

Eligibility criteria

Inclusion Criteria: * American Society of Anesthesiologists (ASA) III, * with Ischemic Heart Disease (history of Myocardial Ischemia, * a history of a positive treadmill test result (Electro Cardio Graph stress test), * use of nitroglycerin, chronic stable angina for more than two months, or an ECG with abnormal Q waves), with ejection fraction (EF) 35%-50%, Exclusion Criteria: * patients under 65 years, * patients with any diseases that increase intraabdominal pressure (any intra-abdominal mass), * general contraindications of spinal anesthesia as patient refusal, coagulation disorders, local infection at the site of the block, psychiatric illness,

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-10-04

1 organization

2 products

2 indications

Organization

New Valley University

Product

Spinal Anesthesia

Indication

Transurethral Resection Syndrome

Indication

Spinal Anesthesia

Product

Saddle Block