Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy

NCT06000098 | Completed

• 1 other identifier: ATADEK 2021-01/2
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Robotic-assisted laparoscopic prostatectomy (RALP) is the gold standard surgical technique in prostate surgery. Many Robotic-laparoscopic surgical techniques also require the intraoperative deep Trendelenburg position and intravenous fluid restriction during surgery. However, the possible side effects of the deep Trendelenburg's position and the fluid restriction on the cardiovascular and renal systems during surgery are unknown. Although the Trendelenburg position is a life-saving maneuver in hypovolemic patients, it also carries undesirable risks. Long console time may contribute to the development of acute kidney injury (AKI) by prolonging the Trendelenburg time and the fluid-restricted time. In this study, investigators aimed to demonstrate the effect of console time on the development of AKI. Investigators also aimed to determine the hemodynamic risk factors that cause the development of AKI in patients monitored with the pressure Recording Analytical Method (PRAM).

Conditions

Acute Kidney Injury; Hemodynamic Instability

Keywords

Robotic-assisted laparoscopic prostatectomy; Acute kidney injury; Restrictive fluid therapy; Pressure recording analytical method

Outcome Measures

Primary Outcomes (1)

• Console time was measured for evaluating the effect of restrictive fluid therapy and prostatic urethra anastomosis time on the development of acute kidney injury.

  Console time ( minute) indicates the restrictive fluid therapy time, prostatic resection, and prostatic urethra anastomosis time.

  The duration of the measurement was defined as during the surgery.

Secondary Outcomes (11)

• Stroke volume variation (SVV) was measured for evaluation of volume status

  The duration of the measurement was defined from one minute before induction to the end of the surgery

• Pulse pressure variation (PPV) was measured for evaluation of volume status

  The duration of the measurement was defined from one minute before induction to the end of the surgery

• Cardiac power output (CPO) was measured for evaluation of cardiac power reserve

  The duration of the measurement was defined from one minute before induction to the end of the surgery

• Cardiac index (CI) was measured for evaluating cardiac flow

  The duration of the measurement was defined from one minute before induction to the end of the surgery

• Dp/Dt was measured to assess cardiac systolic function

  The duration of the measurement was defined from one minute before induction to the end of the surgery

Study Arms (1)

Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.

Patients with ASA( American Society of Anesthesiologists) physical status 1-3 who underwent robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position with restrictive fluid therapy

Other: Restrictive fluid therapy

Interventions

Restrictive fluid therapy OTHER

0,5 ml/hour fluid administration during prostatic anastomosis. After general anesthesia induction, the patients were placed in the deep Trendelenburg position (at least 25°-45° upside down).

Also known as: Trendelenburg position.

Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients with ASA (American Society Of Anesthesiology) physical status 1-3 who underwent RALP with restrictive fluid therapy during console period

You may qualify if:

• Patients with American Society Of Anesthesiology physical status 1-3
• Underwent Robotic-assisted laparoscopic prostatectomy
• Underwent restrictive fluid therapy during the console period

You may not qualify if:

• Under 18 years of age
• Arrhythmia (atrial fibrillation, frequent premature beat)
• History of myocardial infarction in the last 3 months
• Heart failure
• Severe pre-existing lung disease
• Severe valvular heart disease
• Chronic renal disease on dialysis,

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Altunizade Hospital

Istanbul, 31190, Turkey (Türkiye)

Location

Related Publications (7)

• Joo EY, Moon YJ, Yoon SH, Chin JH, Hwang JH, Kim YK. Comparison of Acute Kidney Injury After Robot-Assisted Laparoscopic Radical Prostatectomy Versus Retropubic Radical Prostatectomy: A Propensity Score Matching Analysis. Medicine (Baltimore). 2016 Feb;95(5):e2650. doi: 10.1097/MD.0000000000002650.

  PMID: 26844486 BACKGROUND

• Sudfeld S, Leyh-Bannurah SR, Budaus L, Graefen M, Reese PC, von Breunig F, Reuter DA, Saugel B. Impact of perioperative administration of 6 % hydroxyethyl starch 130/0.4 on serum cystatin C-derived renal function after radical prostatectomy: a single-centre retrospective study. BMC Anesthesiol. 2016 Aug 30;16(1):69. doi: 10.1186/s12871-016-0236-8.

  PMID: 27576693 BACKGROUND

• Lestar M, Gunnarsson L, Lagerstrand L, Wiklund P, Odeberg-Wernerman S. Hemodynamic perturbations during robot-assisted laparoscopic radical prostatectomy in 45 degrees Trendelenburg position. Anesth Analg. 2011 Nov;113(5):1069-75. doi: 10.1213/ANE.0b013e3182075d1f. Epub 2011 Jan 13.

  PMID: 21233502 BACKGROUND

• Emir NS, Akyol D, Sabaz MS, Karadag S. Robotic assited perineal prostatectomy (RAPP) as a new era for anesthesiology: It's effects on hemodynamic parameters and respiratory mechanics. J Robot Surg. 2023 Jun;17(3):933-940. doi: 10.1007/s11701-022-01482-x. Epub 2022 Nov 16.

  PMID: 36383279 RESULT

• Valdivieso RF, Hueber PA, Zorn KC. Robot assisted radical prostatectomy: how I do it. Part I: Patient preparation and positioning. Can J Urol. 2013 Oct;20(5):6957-61.

  PMID: 24128839 RESULT

• Karaveli A, Kavakli AS, Cakin O, Aykal G, Yildiz A, Ates M. Comparison of plasma neutrophil gelatinase-associated lipocalin (NGAL) levels after robot-assisted laparoscopic and retropubic radical prostatectomy: an observational study. Braz J Anesthesiol. 2022 Jan-Feb;72(1):21-28. doi: 10.1016/j.bjane.2021.03.003. Epub 2021 Apr 2.

  PMID: 33819496 RESULT

• Pawlik MT, Prasser C, Zeman F, Harth M, Burger M, Denzinger S, Blecha S. Pronounced haemodynamic changes during and after robotic-assisted laparoscopic prostatectomy: a prospective observational study. BMJ Open. 2020 Oct 5;10(10):e038045. doi: 10.1136/bmjopen-2020-038045.

  PMID: 33020097 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Fevzi Toraman, M.D.

  Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: September 25, 2023
• Primary Completion: October 15, 2023
• Study Completion: October 16, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

TU (1)