Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MD-81-2026 | Other Identifier | anesthesia department faculty of medicine cairo university |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Transurethral resection of the prostate (TURP) is a widely performed surgical procedure for the management of benign prostatic hyperplasia, which affects a significant number of elderly men . TURP involves the removal of prostate tissue via the urethra and is associated with potential fluid shifts, blood loss, and hemodynamic instability. Effective fluid management during the procedure is crucial to ensure optimal patient outcomes, minimizing complications such as hypotension, acute kidney injury, and electrolyte imbalances .
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. Although the goal of these methods is hemodynamic stability, they might not be accurate in dynamically adapting to the specific requirements of each patient, especially when there are large fluid shifts. Furthermore, these approaches frequently overlook the fluctuations in patients' hemodynamic state in real time, which may result in either excessive or insufficient resuscitation 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 .
The PVI has been shown to perform similarly to more invasive and expensive dynamic fluid assessment technologies (such as pulse pressure variation and stroke volume variation) . A small-sized randomized controlled trial (RCT) showed that PVI-directed fluid management reduced the lactate concentrations and improved fluid management in abdominal surgery recipients .
Nevertheless, the clinical outcomes of conventional fluid management with PVI-based GDFT were investigated in previous studies like colorectal surgeries and spine surgeries; we did not find a previous study investigating this strategy in elderly patients undergoing TURP surgery .
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.
Study Procedures
Randomization (in RCT only)
Participants will be randomly assigned into two groups using a computer-generated randomization sequence:
Study Protocol After history taking and examination of the labs (complete blood count, coagulation profile, blood chemistry including creatinine level , Alanine Aminotransferase (ALT) aspartate aminotransferase (AST), Na and K levels ) and airway of the patient, a written informed consent will be obtained, and all patients will fast for 8 hours.
Upon arrival to the operating room, an intravenous wide-bore 18 G venous cannula will be placed, premedication with 2 mg midazolam will be given, and standard monitoring (ECG, oxygen saturation, and non-invasive blood pressure) will be applied. A Masimo SET (Mighty-Sat 9900, Masimo Corporation, Irvine, CA, USA) will be connected to the index finger of the hand in each patient in both groups contralateral to that used for intravenous access and blood pressure and will be shielded with towels to avoid the effects of ambient light on its signals. The Masimo set will be connected to a smart device via Bluetooth, and the plethysmography waveforms will be recorded. Baseline vitals and PVI will be recorded in both groups and then will be recorded every 5 minutes till the end of the operation.
Skin sterilization will be done with the use of povidone-iodine solution to the lower back. This will be repeated 3 times. The area will be draped with sterile towels to maintain a sterile field. Then local anesthesia will be given after identification of the interspace (L4-L5). About 2-3 ml of 2% lidocaine will be injected along the trajectory of the planned spinal needle. Then wait for 1-2 minutes for the local anesthetic to take effect.
A spinal puncture will be performed at the L4-5 level with the patient in the sitting position. After the cerebrospinal fluid is detected, a standard dose of heavy bupivacaine 0.5% (15 mg) with fentanyl (25 μg) (total volume 3.5 ml) will be injected intrathecal via a 25-G Quinke needle. The sensory block level will be targeted: The T10 dermatome. Patients will be positioned supine with a slight head-up tilt to prevent high block. Moreover, 500 mL of acetated Ringer's solution, at an open co-loaded infusion, will be administered over 10 minutes. Hypotension will be defined as a reduction in MAP to ≤ 75% from baseline. Bradycardia (HR < 50). Rescue medication will be given for hypotension (ephedrine, 6 mg, IV) and bradycardia (atropine, 0.6 mg, IV).
Intraoperative monitoring will be standard monitors: ECG, non-invasive blood pressure (NIBP), and pulse oximetry. PVI monitor for Group P heart rate, mean arterial pressure (MAP), SpOâ‚‚, and PVI recorded every 5 minutes.
*Standardization of PVI measurements and handling of lithotomy positioning:-*
Fluid Management
Group Conventional:
Group PVI:
Diuretics will not be administered routinely and will be reserved for patients who develop clinical evidence of fluid overload or pulmonary congestion . Lung ultrasound will be performed at the end of the procedure. In such cases, an intravenous dose of furosemide 1mg/kg will be administered , until lung ultrasound confirms resolution of pulmonary congestion. Lung ultrasound will be performed after 1 hour as the diuretic effect of furosemide is established within 15 minutes and the peak effect occurs within the first half hour . These patients will be recorded as a subgroup.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
• Male patients aged from 50 to 80 years Scheduled for elective TURP.
Exclusion Criteria:
• Cardiac arrhythmias (e.g., atrial fibrillation)
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| mariam saeed toukhy, master degree of anesthesia | anesthesia department at cairo univesrsity hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University Hospitals Anesthesia Department | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Kadir Arslan ASÅž. 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. | ||
| 24182973 | 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. |
Not provided
Not provided
No plan for sharing individual participant data has been developed for this study
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
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.
| 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. |
|
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided