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

NCT ID: NCT06014957

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-30
• Study Completion Date: 2023-12-31

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.

Conditions

TURP Syndrome; Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

spinal anesthesia

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

saddle block

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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,

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

New Valley University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Omar Twaisy

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Omar Twaisy

New Cairo, Kharga, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Twaisy, MD

Role: CONTACT

Twisy200235@med.nvu.edu.eg

01007410757

Facility Contacts

Ahmed Twaisy, MD

Role: primary

Twisy200235@med.nvu.edu.eg

01007410757

References

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.

Reference Type: BACKGROUND

PMID: 26240544 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9212130 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24595149 (View on PubMed)

Other Identifiers

transurethral resection

Identifier Type: -

Identifier Source: org_study_id