Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351241
Status:
COMPLETED
Last Update Posted:
2024-04-08
First Post:
2024-03-18
Brief Title:
Hemodynamic Effects of Steep Trendelenburg Position and Pneumoperitoneum
Sponsor:
Ege University
Organization:
Ege University
Study Overview
Official Title:
Hemodynamic Effects of Steep Trendelenburg Position and Pneumoperitoneum in Urologic Robotic Surgery a Prospective Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed 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 E222840280 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 05 mg atropine 1 mgkg lidocaine 2 - 3 mgkg propofol 1-3 µgkg fentanyl and 06 mgkg rocuronium bromide was performed Following adequate mask ventilation the patients were intubated with an endotracheal tube with an internal diameter of 75 - 85 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 mLkg 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 230 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 Friedmans two-way analysis of variance by rank was employed to assess the differences between dependent measurements at different time points A p-value of 005 was considered statistically significant
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 E222840280 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 05 mg atropine 1 mgkg lidocaine 2 - 3 mgkg propofol 1-3 µgkg fentanyl and 06 mgkg rocuronium bromide was performed Following adequate mask ventilation the patients were intubated with an endotracheal tube with an internal diameter of 75 - 85 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 mLkg 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 230 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 Friedmans two-way analysis of variance by rank was employed to assess the differences between dependent measurements at different time points A p-value of 005 was considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None