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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Anesthesia; TURP Syndrome
• Intervention / Treatment: Drug: spinal anesthesia; Drug: saddle block

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Twaisy, MD; Phone Number: 01007410757; Email: Twisy200235@med.nvu.edu.eg

Study Locations

• Egypt
  • Kharga
    • New Cairo, Kharga, Egypt, 72713
      • Recruiting
      • Ahmed Omar Twaisy
      • Contact: Ahmed Twaisy, MD; Phone Number: 01007410757; Email: Twisy200235@med.nvu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: spinal group; 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.	Drug: 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
Experimental: saddle block group; 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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mean arterial blood pressure	24 hours

Collaborators and Investigators

• Sponsor: New Valley University

Publications and helpful links

General Publications

• Bhattacharyya S, Bisai S, Biswas H, Tiwary MK, Mallik S, Saha SM. Regional anesthesia in transurethral resection of prostate (TURP) surgery: A comparative study between saddle block and subarachnoid block. Saudi J Anaesth. 2015 Jul-Sep;9(3):268-71. doi: 10.4103/1658-354X.158497.
• Rooke GA, Freund PR, Jacobson AF. Hemodynamic response and change in organ blood volume during spinal anesthesia in elderly men with cardiac disease. Anesth Analg. 1997 Jul;85(1):99-105. doi: 10.1097/00000539-199707000-00018.
• Gulec D, Karsli B, Ertugrul F, Bigat Z, Kayacan N. Intrathecal bupivacaine or levobupivacaine: which should be used for elderly patients? J Int Med Res. 2014 Apr;42(2):376-85. doi: 10.1177/0300060513496737. Epub 2014 Mar 4.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: transurethral resection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No