Conventional Fluid Management Versus Plethysmography Variability Index-based Goal-directed Fluid Management in Patients Undergoing Transurethral Resection of the Prostate

NCT07669337 | Active Not Recruiting DMC

• 1 other identifier: MD-81-2026
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Transurethral resection of the prostate (TURP) is a widely performed surgical procedure for the management of benign prostatic hyperplasia. Because of the constant and frequently undetectable fluid exchange through the open prostatic venous sinuses, it is difficult to determine the precise amount of irrigating fluid absorbed after TURP surgery. Unpredictable intravascular volume changes may result from this. While over-resuscitation raises the risk of fluid overload, pulmonary edema, and cardiac events, under-resuscitation in older individuals can lead to hypotension and decreased organ perfusion. Fluid management in TURP has always depended on traditional techniques that employ clinical evaluations like blood pressure and heart rate monitoring or fixed-volume infusion procedures. By using advanced technologies, goal-directed fluid therapy (GDFT) methods continually monitor and evaluate a patient's physiological status in real time, modifying fluid dosage as necessary. A dynamic method for determining volume status, the plethysmography variability index (PVI) has been studied in numerous clinical settings and has proven reliable in predicting fluid responsiveness and acting as a fluid resuscitation guide

Conditions

Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection

Keywords

begnin prostatic hyperplasia; transurethral resection of the prostate

Outcome Measures

Primary Outcomes (1)

• The total amount of intraoperative crystalloid administered by each group.

  the amount of crystalloids bottles given to the patient during the intra operative period

  24 hours

Study Arms (2)

Conventional Fluid Management.

ACTIVE COMPARATOR

Participants will receive conventional intraoperative fluid management according to the study protocol, based on mean arterial pressure (MAP) monitoring and fluid administration as clinically indicated.

Other: Conventional Fluid Management

PVI-Guided Goal-Directed Fluid Manage

EXPERIMENTAL

Participants will receive intraoperative fluid management guided by Plethysmography Variability Index (PVI) measurements according to the study protocol, with fluid administration adjusted based on PVI values and hemodynamic parameters.

Other: Plethysmography Variability Index (PVI)-Guided Goal-Directed Fluid Management

Interventions

Conventional Fluid Management OTHER

Participants will receive conventional intraoperative fluid management according to the study protocol, based on mean arterial pressure (MAP) monitoring and fluid administration as clinically indicated.

Conventional Fluid Management.

Plethysmography Variability Index (PVI)-Guided Goal-Directed Fluid Management OTHER

Participants will receive intraoperative fluid management guided by Plethysmography Variability Index (PVI) measurements according to the study protocol, with fluid administration adjusted based on PVI values and hemodynamic parameters.

PVI-Guided Goal-Directed Fluid Manage

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients aged from 50 to 80 years Scheduled for elective TURP.
• ASA Ⅰ, Ⅱ.

You may not qualify if:

• Cardiac arrhythmias (e.g., atrial fibrillation)
• Left ventricular ejection fraction \<40%
• Chronic kidney disease (stage ≥ 3)
• Hepatic dysfunction
• Peripheral vascular disease
• Prolonged procedures more than 2 hours or complicated procedures with severe bleeding affecting management (Severe bleeding will be defined as any of the following: a drop in hemoglobin of ≥ 2 g/dl, hemodynamic instability due to blood loss that requires blood transfusion).
• Patients refuse to share in this study.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals Anesthesia Department

Cairo, Egypt

Location

Related Publications (3)

• Kadir Arslan ASŞ. Transurethral Resection of the Prostate (TURP) Syndrome: A Review of Perioperative Management. Comprehensive Medicine 2024;16(2):123-7.

  BACKGROUND

• Pandya DS. TURP Syndrome. Practical Guidelines on Fluid Therapy. Third ed2024. p. 537-43.

  BACKGROUND

• Tapscott AH, Hakim LS. Office-based management of impotence and Peyronie's disease. Urol Clin North Am. 2013 Nov;40(4):521-43. doi: 10.1016/j.ucl.2013.07.003. Epub 2013 Sep 3.

  PMID: 24182973 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• mariam saeed toukhy, master degree of anesthesia

  anesthesia department at cairo univesrsity hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This randomized controlled trial (RCT) aims to compare the clinical outcomes of conventional fluid management with PVI-based GDFT in patients undergoing TURP. We hypothesize that PVI-guided fluid management will result in better intraoperative hemodynamic stability, a reduction in postoperative complications, and an overall improvement in patient recovery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: conventional fluid management or plethysmography variability index (PVI)-guided goal-directed fluid management during transurethral resection of the prostate (TURP). Outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: June 25, 2026
• Study Start: March 15, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)