Inferior Vena Cava Diameter Dependent Colloid Challenge Versus Routine Crystalloid Strategy Transurethral Resection Prostate

NCT04131361 | Completed

• 1 other identifier: R.19.10.644
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Intravenous fluid replacement during transurethral resection of the prostate is still unclear. Ultrasonography of the inferior vena cava (IVC) has been recently used to assess the volume status and predict fluid responsiveness. In this double-blind, randomized controlled study, we will assess the IVC at baseline and at subsequent time points after spinal anesthesia, and according to IVC diameter will give the replacement challenge colloid. Potential problems during TURP are mostly due to either fluid overload or bleeding: Intraoperative TURP syndrome, Hemorrhage, Myocardial ischemia, Hypothermia, Prostatic capsular perforation, Bladder or urethral perforation. Postoperative TURP syndrome, myocardial ischemia/infarction, Postoperative cognitive impairment. Study Hypothesis: Strict colloid volume optimization using US-guided IVC diameter calculation aiming decrease the total IV fluid volume and accommodate the transurethral inevitable absorption of currently used irrigation crystalloid fluid (Nacl0.9%) that accidentally absorbed and change it from a circulatory overload to a complementary part of the replacement IV fluids preventing fluid overload and TURP syndrome. Aim of the work: To reduce Intraoperative and postoperative fluid overload during TURP surgery with hemodynamic stability relaying up on US-guided IVC diameter dependent Strict IV Colloid replacement volume optimization. Methods: A prospective randomized controlled trial on ASAI-III male patient aged 40-80 years old subjected to transurethral endoscopic resection of the prostate (TURP) surgery. Then patients will be divided into 2 groups according to the IV infusion fluid type as follow: Crystalloid -control group: (preload plus continuous IO Ringer acetate crystalloid 4/2/1 rule infusion) according to the usual 4/2/1 rule. Not guided by IVC diameter but IVC diameter will be calculated using the US and recorded at baseline just after spinal anesthesia and then every 30 minutes till the end of surgery. Loop Diuretic (Furosemide) will be given according to the maximum diameter of the IVC as follow; 10mg if IVC\>2.5Cm. Colloid- study group: (preload plus colloid challenge only); Fluid challenge boluses of 250 mL (over 5 minutes using a pressurizer) 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) if the IVC\<1.7(higher limit of normal) will be given guided by IVC diameter at baseline just after spinal anesthesia and then every 30 minutes till the end of surgery.

Conditions

Volume Overload

Outcome Measures

Primary Outcomes (1)

• total iv fluids

  just after end of surgery

Secondary Outcomes (6)

• serum Na at end of surgery

  just after end of surgery

• serum K at end of surgery

  just after end of surgery

• ximum and minimum IVC diameter

  serial during surgery

• IVC-CI

  serial during surgery

• Incidence of bradycardia

  serial during surgery

Study Arms (2)

Crystalloid -control group:

ACTIVE COMPARATOR

Other: Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement

Colloid- study group:

EXPERIMENTAL

Other: Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement

Interventions

Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement OTHER

The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region.

Colloid- study group:; Crystalloid -control group:

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients subjected to transurethral resection of prostate TURP.
• ASA I\&II
• Age 40-80years old. prostate size 45-100
• Surgical procedure: laser and Bipolar TURP using saline 0,9% irrigation.

You may not qualify if:

• Height \<150 cm.
• Weight \<60 kg.
• Body mass index ≥45 kg/m2.
• Contraindications to spinal anesthesia (increased intracranial pressure or local skin infection).
• Uncontrolled; Diabetes mellitus, cardiovascular failure, cerebrovascular uncontrolled deficite, or other renal disease.
• Hemoglobin \<10 gm/dL.
• International Normalized Ratio \>1.4
• Platelet count \<100,000 /mm3.
• Preoperative serum creatinine \>1.5 mg/dL

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Anesthesia Department

Al Mansurah, Dakahlia Governorate, 35931, Egypt

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor os anesthesia ICU & Pain medicine.

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: October 18, 2019
• Study Start: October 1, 2022
• Primary Completion: December 25, 2022
• Study Completion: December 30, 2022
• Last Updated: June 12, 2023

Record last verified: 2023-06

Locations

EG (1)