Hemodynamic Effects of Trendelenburg Position and Pneumoperitoneum in Urologic Robotic Surgery

NCT07848581 | Completed

• 1 other identifier: E-70198063-050.06.04-222840
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

During robot-assisted prostate surgery, the abdomen is routinely inflated with gas to allow clear visualization through the camera, and the patient is placed in a head-down (Trendelenburg) position. The aim of this study is to observe the effects of the surgical position (head-down position) and abdominal gas inflation on certain blood pressure, pulse, respiratory, and cardiac values that are routinely monitored during anesthesia, in patients undergoing robot-assisted prostate surgery under general anesthesia. Participants will receive the anesthesia method planned for the diagnosis and treatment of their condition. Before anesthesia, a routine pre-anesthesia examination will be performed, and information such as age, height, weight, diagnosis, and the name of the planned surgery will be recorded. During surgery, certain values that are routinely measured will be recorded. The recorded data will be entered into a computer, analyzed statistically, and the results will be reviewed.

Conditions

Pneumoperitoneum, Artificial; Hemodynamics; Prostatic Neoplasms

Keywords

Perfusion Index; Plethysmographic Variability Index; Robotic Surgery; Pneumoperitoneum; Steep Trendelenburg Position

Outcome Measures

Primary Outcomes (2)

• Change in Perfusion Index

  Perfusion Index (PI) is a non-invasive, continuous measure of peripheral perfusion derived from pulse oximetry. PI values range from 0.02 (very low perfusion) to 20 (very high perfusion); higher values indicate better peripheral perfusion. PI will be recorded at 10 predetermined intraoperative time points: before anesthesia induction, 5 minutes after induction, 5 minutes after steep Trendelenburg positioning, 5 minutes after pneumoperitoneum, 5, 15, and 30 minutes after combined pneumoperitoneum and Trendelenburg positioning, upon return to the supine position, after CO2 desufflation, and after extubation.

  Perioperative period, from baseline (before anesthesia induction) through extubation, an average of 3-4 hours

• Change in Pleth Variability Index

  Pleth Variability Index (PVI) is a dynamic, non-invasive parameter derived from respiratory variations in the perfusion index, expressed as a percentage. PVI values range from 0% to 100%. Higher values indicate greater fluid responsiveness / greater respiratory-induced variation in perfusion, which may reflect hypovolemia. PVI will be recorded at 10 predetermined intraoperative time points: before anesthesia induction, 5 minutes after induction, 5 minutes after steep Trendelenburg positioning, 5 minutes after pneumoperitoneum, 5, 15, and 30 minutes after combined pneumoperitoneum and Trendelenburg positioning, upon return to the supine position, after CO2 desufflation, and after extubation.

  Perioperative period, from baseline (before anesthesia induction) through extubation, an average of 3-4 hours

Interventions

Pneumoperitoneum and Trendelenburg Position PROCEDURE

During robot-assisted laparoscopic radical prostatectomy (RALRP), the abdominal cavity is insufflated with carbon dioxide gas to create a pneumoperitoneum, and the patient is placed in a steep head-down (Trendelenburg) position to facilitate surgical visualization. This study observes the hemodynamic and respiratory effects of these standard surgical conditions.

Eligibility Criteria

• Age: 25 Years - 80 Years
• Gender Eligibility Details: Male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of patients undergoing elective RALRP (Robot-Assisted Laparoscopic Radical Prostatectomy) surgery under general anesthesia at the Robotic Surgery Unit, Ege University Faculty of Medicine.

You may qualify if:

• Patients with ASA physical status I-II-III Patients between 25-80 years of age Patients scheduled for elective RALRP (Robot-Assisted Laparoscopic Radical Prostatectomy) surgery under general anesthesia

You may not qualify if:

• Patients with an ASA score above III Patients who do not provide consent to participate in the study Patients unsuitable for robotic surgery Conversion to open surgery for any reason Patients who develop hemodynamic instability during the intraoperative period Patients who develop respiratory complications during the intraoperative period

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Hospital

Izmir, İzmir, 35000, Turkey (Türkiye)

Location

Related Publications (3)

• Ghoundiwal D, Delaporte A, Bidgoli J, Forget P, Fils JF, Van der Linden P. Effect of pneumoperitoneum on dynamic variables of fluid responsiveness (Delta PP and PVI) during Trendelenburg position. Saudi J Anaesth. 2020 Jul-Sep;14(3):323-328. doi: 10.4103/sja.SJA_737_19. Epub 2020 May 30.

  PMID: 32934624 BACKGROUND

• 2. Arslantas R, Arslantas MK, Tore Altun G, Corman Dıncer P. The effects of pneumoperitoneum and patient position on the perfusion index and pleth variability index during laparoscopic bariatric surgery. Marmara Med J 2020;33(2): 54-60.

  BACKGROUND

• Vincent JL, Pelosi P, Pearse R, Payen D, Perel A, Hoeft A, Romagnoli S, Ranieri VM, Ichai C, Forget P, Della Rocca G, Rhodes A. Perioperative cardiovascular monitoring of high-risk patients: a consensus of 12. Crit Care. 2015 May 8;19(1):224. doi: 10.1186/s13054-015-0932-7.

  PMID: 25953531 BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum; Prostatic Neoplasms

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 30, 2026
• Study Start: November 29, 2022
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)