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

Robotic Surgery Clinical Trial

Official title:

The Effect of Low-flow and Normal-flow Desflurane Anesthesia on Respiratory Parameters in Robotic-assisted Radical Prostatectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05517551
• Other study ID #: E1-22-2755
• Status: Not yet recruiting
• Start date: August 2022
• Est. completion date: March 2023

Study information

• Verified date: August 2022
• Source: Ankara City Hospital Bilkent
• Contact: betül güven aytaç, MD
• Phone: 05073578351
• Email: drbguven[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 68
• Est. completion date: March 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• ASA I-II risk group

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Low Flow Anesthesia
• Robotic Surgery

Intervention

Procedure:
• robotic assisted radical prostatectomy
Patients who will undergo robotic-assisted laparoscopic prostatectomy surgery

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	partial oxygen pressure	PO2 from blood gas analysis	from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)
Secondary	desflurane consumption	desflurane consumption at the end of anesthesia is measured from anesthesia machine monitor	perioperative
Secondary	changes in liver and kidney function tests from the preoperative values to 48 hours postoperative	to determine the changes in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), and creatinine from the preoperative values to 48 hours postoperative	during operation and 48 hours postoperative