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

Not Applicable

Recruiting

• Conditions: TURP Syndrome; Spinal Anesthesia
• Interventions: Drug: spinal anesthesia; Drug: saddle block

• Registration Number: NCT06014957
• Lead Sponsor: New Valley University

Brief Summary

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.

Detailed Description

TURP is performed by inserting a resectoscope through the urethra and resecting prostatic tissue with an electrically powered cutting-coagulating metal loop or using laser-22 vaporization energy. This can be accomplished with either a monopolar TURP (M-TURP) or bipolar TURP (B-TURP) technique. Laser energy for TURP has also been used for many years. With each technique, as much prostatic tissue as possible is resected, but the prostatic capsule is usually preserved. If the capsule is violated, large amounts of irrigation solution can be absorbed into the circulation via the periprostatic, retroperitoneal, or peritoneal space. Bleeding during TURP is not uncommon but usually controllable; hemostasis becomes difficult when large venous sinuses are opened. If the bleeding becomes uncontrollable, the procedure should be terminated as quickly as possible, and a Foley catheter should be passed into the bladder and traction applied to it. The catheter's inflated balloon exerts lateral pressure on the prostatic bed and reduces bleeding. Bleeding requiring transfusion occurs in approximately 2.5% of TURP procedures.

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-25
• Study First Posted: 2023-08-28
• Study Start: 2023-08-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-04
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
spinal group	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.
saddle block 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.

Primary Outcome Measures

Name	Time	Method
mean arterial blood pressure	24 hours

Trial Locations

Locations (1)

Ahmed Omar Twaisy; 🇪🇬 New Cairo, Kharga, Egypt