Comparison of Low and Normal Flow Anesthesia in Robotic Assisted Radical Prostatectomy

NCT05517551 | Unknown

• 1 other identifier: E1-22-2755
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Robot-assisted laparoscopic radical prostatectomy has gained increasing popularity compared to open radical prostatectomy with its advantages such as low blood loss, reduced blood transfusion rate, low complication rate, and shortened hospital stay. Since robot-assisted laparoscopic radical prostatectomy should be performed in the limited retroperitoneal area, insufflation of the abdomen with carbon dioxide (CO2) (pneumoperitoneum) and steep Trendelenburg position are required to provide better surgical vision. Low-flow anesthesia warms and moistens the inhaled gases, creating a more physiological breathing atmosphere during anesthesia. In addition, it provides cost advantage by reducing inhalation agent consumption and reduces atmospheric pollution. Studies show that long-term minimal flow anesthesia is safe and advantageous for non-laparoscopic surgery. The aim of this study is to compare low-flow (1L/min) with normal flow (3lt/min) desflurane anesthesia in terms of hemodynamic and respiratory parameters, inhalation agent consumption and soda lime consumption for robotic assisted laparoscopic radical prostatectomy surgery. The secondary aim of the study is to compare the effects of low-flow and normal-flow anesthesia in the steep trendelenburg position (45°) used for robotically assisted laparoscopic radical prostatectomy.

Conditions

Low Flow Anesthesia; Normal Flow Anesthesia; Robotic Surgery

Outcome Measures

Primary Outcomes (2)

• inspiratory O₂ concentration

  inspiratory O₂ concentration is measured from anesthesia machine monitor

  from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)

• partial oxygen pressure

  PO2 from blood gas analysis

  from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)

Secondary Outcomes (2)

• desflurane consumption

  perioperative

• changes in liver and kidney function tests from the preoperative values to 48 hours postoperative

  during operation and 48 hours postoperative

Study Arms (2)

normal flow anesthesia

A fresh gas flow of 3 L/min will be applied continuously

Procedure: robotic assisted radical prostatectomy

low flow anesthesia

A fresh gas flow of 3 L/min will be applied for the first 20 minutes after intubation , and then it will be reduced to 1 L/min.

Procedure: robotic assisted radical prostatectomy

Interventions

robotic assisted radical prostatectomy PROCEDURE

Patients who will undergo robotic-assisted laparoscopic prostatectomy surgery

low flow anesthesia; normal flow anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who will undergo robotic-assisted laparoscopic prostatectomy surgery

You may qualify if:

• \- ASA I-II risk group

You may not qualify if:

• ASA III, IV, V,
• concomitant serious cardiac, respiratory, hepatic, renal disturbance,
• mental status disorder and hearing problem,
• anxiety and depression and/or other psychiatric disorders,
• patient's refusal

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Central Study Contacts

betül güven aytaç, MD

CONTACT

05073578351; drbguven@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 26, 2022
• Study Start: August 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

TU (1)