Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06351241 |
| Other study ID # |
E.222840/280 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 29, 2022 |
| Est. completion date |
April 14, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Ege University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
Introduction Robot-assisted laparoscopic radical prostatectomy (RYLRP) is currently the most
frequently performed surgical procedure using the Da Vinci Robotic System. In this procedure,
the steep Trendelenburg position (30° - 45° head down) and pneumoperitoneum (insufflation of
the intraabdominal space with CO2) are used to enhance surgical visibility in the
retroperitoneal area. However, the patient position and pneumoperitoneum used in robotic
surgery can lead to fluctuations in hemodynamic parameters resulting from physiological
changes in the cardiovascular and respiratory systems. Consequently, proper hemodynamic
monitoring and optimal fluid management can reduce the risk of complications and improve
outcomes in patients.
Perfusion index (PI) is a hemodynamic parameter calculated by looking at the absorption of
infrared light by pulse oximetry to evaluate continuous tissue perfusion for a specific time
interval. In contrast, the Pleth variability index (PVI), a dynamic variable used for
regulating fluid management, is computed based on changes in PI caused by ventilation over at
least one respiratory cycle. Both parameters are key non-invasive methods for hemodynamic
monitoring during patient follow-up as they provide accurate information about tissue
perfusion. However, only a few studies have evaluated the effects of patient position and
pneumoperitoneum on PI and PVI in laparoscopic surgeries. Therefore, this study aimed to
prospectively investigate the effects of the steep Trendelenburg position and
pneumoperitoneum on PVI and PI in patients scheduled for RYLRP under general anesthesia.
Materials and methods This prospective observational study was approved by the Ege University
Faculty of Medicine Clinical Research Ethics Committee (approval number: E222840/280; dated
July 7, 2021). Patients belonging to ASA classes I-II, aged between 25 and 80 years, and
scheduled for elective RYLRP 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. Two patients were eventually dropped from the study
because of conversion to open surgery. Additionally, patients with an ASA score above III,
those unsuitable for robotic surgery, and those who developed hemodynamic instability or
respiratory complications during the intraoperative period were excluded.
Preanesthetic evaluations of the patients were performed at least 24 hour before the
operation. Preoperative data, including age, weight, height, body mass index, ASA
classification, and additional medical history, were recorded for each patient.
After being admitted to the operating room, standard monitoring (electrocardiogram,
non-invasive blood pressure, peripheral oxygen saturation) was performed. In addition,
non-invasive hemoglobin, PI, and PVI monitoring were conducted using a finger probe (Masimo
Radikal 7, Masimo Corp., Irvine, CA, USA) which was placed on the fourth digit of the hand
without the non-invasive blood pressure cuff. A 16-G or 18-G intravenous (IV) cannula was
inserted, and an Isolyte-S infusion was initiated.
After 3 min of pre-oxygenation with 100% O2, standard anesthesia induction (using 0.5 mg
atropine, 1 mg/kg lidocaine, 2 - 3 mg/kg propofol, 1-3 µg/kg fentanyl, and 0.6 mg/kg
rocuronium bromide) was performed. Following adequate mask ventilation, the patients were
intubated with an endotracheal tube with an internal diameter of 7.5 - 8.5 mm. The
endotracheal tube placement was verified by confirming equal ventilation in both lungs and
observing the end-tidal carbon dioxide (ETCO2) waveform in the capnograph. Patients were then
placed on volume-controlled mechanical ventilation with a tidal volume of 6-8 mL/kg and ETCO2
maintained at 35 - 40 mmHg. Invasive arterial blood pressure measurements were performed via
radial artery cannulation throughout the operation. Anesthesia maintenance included a mixture
of 50 % O2 and air with 2 % MAC sevoflurane (Sevoflurane Liquid 250 ml®, Abbott, UK) and
remifentanil infusion.
After anesthesia induction and intubation, the patients were placed in a 45° steep
Trendelenburg position. Five minutes after positioning, hemodynamic and respiratory
parameters were recorded, and the patients were returned to the supine position. After
returning to the supine position, pneumoperitoneum was established with CO2, and hemodynamic
and respiratory parameters were recorded again 5 min later.
Measurements were taken at the following time points: before anesthesia induction (T0), 5 min
after induction (T1), 5 min after the steep Trendelenburg position was applied (T2), 5 min
after establishing pneumoperitoneum (T3), 5 min (T4), 15 min (T5) and 30 min (T6) after
pneumoperitoneum and the steep Trendelenburg position were applied together, upon returning
to the supine position (T7), after CO2 desufflation (T8), and after extubation (T9). The
following parameters were recorded: hemodynamic parameters (systolic blood pressure,
diastolic blood pressure, mean arterial pressure, heart rate, PI, and PDI), respiratory
parameters (tidal volume, respiratory rate, peak airway pressure, mean airway pressure, PEEP,
ETCO2, oxygen saturation (SpO2), and compliance), intraabdominal pressure, non-invasive
hemoglobin, and body temperature. At the end of the surgery, the operation time, anesthesia
time, pneumoperitoneum duration, intraoperative fluid volume administered, urine output, and
intraoperative bleeding amount were recorded (Figure 1).
The data so collected were analyzed using IBM SPSS (version 23.0; IBM Corp., Armonk, NY).
Frequency and percentage were computed for categorical data, whereas mean, standard deviation
(SD), median, and range were presented as descriptive values for continuous data. Friedman's
two-way analysis of variance by rank was employed to assess the differences between dependent
measurements at different time points. A p-value of 0.05 was considered statistically
significant.
