Hemodynamic Effects of Steep Trendelenburg Position and Pneumoperitoneum

NCT06351241 | Completed

• 1 other identifier: E.222840/280
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND: The steep Trendelenburg position and pneumoperitoneum are used to improve surgical visibility in robot-assisted laparoscopic radical prostatectomy (RALRP). However, these procedures can lead to hemodynamic changes. This study aimed to investigate the effects of these interventions on the perfusion index (PI) and the Pleth variability index (PVI) in patients undergoing RALRP under general anesthesia. METHODS: Fifty-three patients scheduled for RALRP underwent standard monitoring; PI and PVI values were monitored using a finger probe. PI, PVI, hemodynamic and respiratory parameters, and intraabdominal pressure were recorded before and after anesthesia induction, after adopting the Trendelenburg position, after pneumoperitoneum, after pneumoperitoneum and the Trendelenburg position, at 15 min, 30 min, in the supine position, after carbon dioxide (CO2) desufflation, and after extubation.

Conditions

Perfusion Index; Pleth Variability Index

Keywords

Perfusion index; Pleth variability index; Robotic surgery; Pneumoperitoneum; Steep trendelenburg position

Outcome Measures

Primary Outcomes (1)

• Hemodynamic effects of steep trendelenburg position and pneumoperitoneum in urologic robotic surgery

  Can steep trendelenburg position and pneumoperitoneum cause hemodynamic changes in urologic robotic surgery? Hemodynamic measurements were taken at specific time points during the operation. The following hemodinamic parameters, Perfusion index (PI) and Pleth variability index, were recorded.

  1 year

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients belonging to ASA classes I-II, aged between 25 and 80 years, and scheduled for elective robot-assisted laparoscopic radical prostatectomy under general anesthesia were included in the study. Patients deemed suitable for the study were explained about the study, and written voluntary informed consent for participation was obtained.

You may qualify if:

• Patients belonging to ASA classes I-II
• Aged between 25 and 80 years
• Elective robot-assisted laparoscopic radical prostatectomy under general anesthesia

You may not qualify if:

• conversion to open surgery
• patients with an ASA score above III
• unsuitable for robotic surgery
• who developed hemodynamic instability or respiratory complications during the intraoperative period

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Nursen Karaca

Bornova, İzmir, 35040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Işık Alper

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 8, 2024
• Study Start: November 29, 2022
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

TU (1)