Pneumoperitoneum, ArtificialNCT07848581

Hemodynamic Effects of Trendelenburg Position and Pneumoperitoneum in Urologic Robotic Surgery

An observational study of Pneumoperitoneum, Artificial and Hemodynamics, run by Ege University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 80 years, men only
Conditions the study is for: Pneumoperitoneum, Artificial, Hemodynamics, Prostatic Neoplasms
What is being tested?: Pneumoperitoneum and Trendelenburg Position
Type of treatment: Surgery or procedure
How many people: 55 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 29 Nov 2022to 14 Apr 2023
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 80 years
Men only
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ege University Hospital
Izmir, İzmir, 35000

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects Of The Trendelenburg Position And Pneumoperitoneum On Perfusion Index And Pleth Variability Index In Urological Robotic Surgery

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.

Read the detailed description

In order to improve surgical visibility in robot-assisted laparoscopic radical prostatectomy (RALRP), the steep Trendelenburg position and pneumoperitoneum are used.These procedures can lead to changes in intrathoracic pressure, affecting hemodynamic parameters. There are limited studies on the use of these techniques in robot-assisted surgeries. In this study, we aimed to investigate the effects of the steep Trendelenburg position and pneumoperitoneum on the 'Perfusion Index' (PI) and 'Pleth Variability Index' (PVI) in patients undergoing RYLRP under general anesthesia. After obtaining approval from the Hospital Ethics Committee (E.222840/280) and written consent from patients, 55 patients scheduled for RALRP were included in the study. Patients underwent standard monitoring, and Perfusion Index (PI) and Pleth Variability Index (PVI) were monitored using a finger probe. Measurements were taken before induction, after induction, after adopting the Trendelenburg position, after pneumoperitoneum, after pneumoperitoneum and the Trendelenburg position, at 15 minutes, 30 minutes, in the supine position, after CO2 desufflation, and after extubation. During these stages, PI, PVI, hemodynamic, and respiratory parameters, as well as intraabdominal pressure, were recorded.

Conditions: Pneumoperitoneum, Artificial, Hemodynamics, Prostatic Neoplasms
Being tested: Pneumoperitoneum and Trendelenburg Position
Keywords: Perfusion Index, Plethysmographic Variability Index, Robotic Surgery, Pneumoperitoneum, Steep Trendelenburg Position
Medical subject headings: Pneumoperitoneum, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pneumoperitoneum and Trendelenburg PositionProcedure or surgery
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Nov 202214 Apr 2023

First posted30 Sep 2026
Study start29 Nov 2022
Primary completion14 Apr 2023
Study completion14 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Pneumoperitoneum, ArtificialStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07848581
Sponsor's protocol ID: E-70198063-050.06.04-222840
Status last verified: Sep 2026
First submitted: 16 Sep 2026
Last updated: 30 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 32934624
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.
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.
PubMed 25953531