- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05517551
Comparison of Low and Normal Flow Anesthesia in Robotic Assisted Radical Prostatectomy
The Effect of Low-flow and Normal-flow Desflurane Anesthesia on Respiratory Parameters in Robotic-assisted Radical Prostatectomy
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ankara
-
Ankara, Ankara, Turkey (Türkiye)
- Ankara City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ASA I-II-III risk group
Exclusion Criteria:
- ASA 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
normal flow anesthesia
A fresh gas flow of 3 L/min will be applied continuously
|
Patients who will undergo robotic-assisted laparoscopic prostatectomy surgery
|
|
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.
|
Patients who will undergo robotic-assisted laparoscopic prostatectomy surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
inspiratory O₂ concentration
Time Frame: from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)
|
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
Time Frame: from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)
|
PO2 from blood gas analysis
|
from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
desflurane consumption
Time Frame: perioperative
|
desflurane consumption at the end of anesthesia is measured from anesthesia machine monitor
|
perioperative
|
|
changes in liver and kidney function tests from the preoperative values to 48 hours postoperative
Time Frame: during operation and 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E1-22-2755
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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