Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04671121
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2020-12-10
Brief Title:
Pneumoperitoneum and Cerebral Oxygenation
Sponsor:
Ondokuz Mayıs University
Organization:
Ondokuz Mayıs University
Study Overview
Official Title:
An Analysis of Cerebral Oximetry After Low Pressure Compared With Standard Pressure Pneumoperitoneum in Patients Undergoing Laparoscopic Nephrectomy A Prospective Randomized Parallel-Group Study
Status:
COMPLETED
Status Verified Date:
2020-12
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:
In this study the changes in cerebral oxygen saturation due to low and high pressure pneumoperitoneum implementation were measured in patients who underwent laparoscopic nephrectomy This prospective double-blind study included 62 American Society of Anesthesiologists ASA PS class I-III patients aged 18-65 years who underwent laparoscopic nephrectomy simple partial or radical Patients were randomly classified into 2 groups Group LP n 31 included patients who were treated with low pressure pneumoperitoneum 8 mmHg and Group SP n 31 included patients who were treated with standard pressure 14 mmHg A standard anesthesia protocol was used in both groups Bilateral rSO2 values were recorded at baseline at 1 minute after induction and then every 5 minutes until the patient went to the recovery unit Data for mean arterial pressure MAP peak heart rate HR peripheral oxgen saturation SpO2 and end-tidal carbon dioxide ETCO2 were also recorded at the same time intervals Arterial blood gas was analyzed in the 5th minute after induction t1 while the patient was in the supine position in the 5th and 30th minutes after insufflation t2 t3 while the patient was in the lateral semi-oblique position and again 10 minutes after desufflation t4 while the patient was in the supine position Patient demographic data duration of anesthesia duration of surgery lateral position time pneumoperitoneum time and recovery time were also recorded used in both groups Bilateral rSO2 values were recorded at baseline at 1 minute after induction and then every 5 minutes until the patient went to the recovery unit Data for mean arterial pressure MAP peak heart rate HR SpO2 and ETCO2 were also recorded at the same time intervals Arterial blood gas was analyzed in the 5th minute after induction t1 while the patient was in the supine position in the 5th and 30th minutes after insufflation t2 t3 while the patient was in the lateral semi-oblique position and again 10 minutes after desufflation t4 while the patient was in the supine position Patient demographic data duration of anesthesia duration of surgery lateral position time pneumoperitoneum time and recovery time were also recorded
Detailed Description:
A total of 62 American Society of Anesthesiologists ASA PS class I-III patients between the ages of 18 and 65 years who were scheduled for elective laparoscopic nephrectomy simple partial or radical were included in the study
A standard anesthesia protocol was used in both groups Patients did not receive any sedative premedication Upon entering the operating room they underwent electrocardiogram non-invasive blood pressure peripheral oxygen saturation SpO2 rSO2 INVOS TM 5100C oximeter Covidien and neuromuscular monitoring TOF-WatchTM SX Organon Dublin Ireland Subsequently anesthesia was induced with propofol 15-25 mgkg and remifentanil 1 mcgkg IV bolus for 30-60 seconds then 025 mcgkgmin and rocuronium 12 mgkg Anesthesia was maintained with O2Air fraction of inspired oxygen of 040 inspiratory fresh gas flow of 2 Lmin sevoflurane 1 minimum alveolar concentration and remifentanil IV infusion 01-025 mcgkgmin Radial arterial cannulation was also applied for arterial blood gas analysis and continuous blood pressure measurement A mechanical ventilator Draeger FabiusTM Plus anesthesia Workstation Draeger Medical Lübeck Germany was used at settings of tidal volume 7-8 mLkg inspiriumexprium expiratory ratio 12 and positive end-expiratory pressure of 5 cmH2O With these settings pre-insufflation Sp02 values were maintained at 96 while the respiratory rate was determined with end-tidal CO2 ETCO2 of 32-37 mmHg These ventilator settings were maintained throughout the operation
CO2 insufflation was performed using the closed Veress needle technique with electronic laparoflators in the patients who were placed in lateral semi-oblique 60 and some flexion jackknife positions before the surgery was started Intra-abdominal pressure was maintained at 8 mmHg in Group LS and at 14 mmHg in Group SP throughout the surgery
During the operation a neuromuscular blockade was achieved with rocuronium infusion 03-04 mgkghour with a post-tetanic count of zero At the end of the case extubation was provided by decurarizing the rocuronium with a combination of 002mgkg atropine and 004 mgkg neostigmine All patients were followed up with nasopharyngeal temperature monitoring and were actively warmed using a forced-air warming system to ensure normothermia throughout the surgery Patients were followed up in the recovery unit at the end of the surgery until their modified Aldrete score reached 9
Hemodynamics The data of mean arterial pressure MAP peak heart rate HR SpO2 and ETCO2 were recorded at baseline at 1 minute after induction and then every 5 minutes until the patient went to the recovery unit MAP and HR values were kept at 20 of preoperative values by changing the remifentanil infusion rate Hypotension MAP was defined as 60 mmHg and bradycardia HR as 45 beatsminute and these were treated with noradrenaline 4-8 mcg atropine 05 mg Patients who required noradrenaline or atropine more than twice were excluded from the study
A standard anesthesia protocol was used in both groups Patients did not receive any sedative premedication Upon entering the operating room they underwent electrocardiogram non-invasive blood pressure peripheral oxygen saturation SpO2 rSO2 INVOS TM 5100C oximeter Covidien and neuromuscular monitoring TOF-WatchTM SX Organon Dublin Ireland Subsequently anesthesia was induced with propofol 15-25 mgkg and remifentanil 1 mcgkg IV bolus for 30-60 seconds then 025 mcgkgmin and rocuronium 12 mgkg Anesthesia was maintained with O2Air fraction of inspired oxygen of 040 inspiratory fresh gas flow of 2 Lmin sevoflurane 1 minimum alveolar concentration and remifentanil IV infusion 01-025 mcgkgmin Radial arterial cannulation was also applied for arterial blood gas analysis and continuous blood pressure measurement A mechanical ventilator Draeger FabiusTM Plus anesthesia Workstation Draeger Medical Lübeck Germany was used at settings of tidal volume 7-8 mLkg inspiriumexprium expiratory ratio 12 and positive end-expiratory pressure of 5 cmH2O With these settings pre-insufflation Sp02 values were maintained at 96 while the respiratory rate was determined with end-tidal CO2 ETCO2 of 32-37 mmHg These ventilator settings were maintained throughout the operation
CO2 insufflation was performed using the closed Veress needle technique with electronic laparoflators in the patients who were placed in lateral semi-oblique 60 and some flexion jackknife positions before the surgery was started Intra-abdominal pressure was maintained at 8 mmHg in Group LS and at 14 mmHg in Group SP throughout the surgery
During the operation a neuromuscular blockade was achieved with rocuronium infusion 03-04 mgkghour with a post-tetanic count of zero At the end of the case extubation was provided by decurarizing the rocuronium with a combination of 002mgkg atropine and 004 mgkg neostigmine All patients were followed up with nasopharyngeal temperature monitoring and were actively warmed using a forced-air warming system to ensure normothermia throughout the surgery Patients were followed up in the recovery unit at the end of the surgery until their modified Aldrete score reached 9
Hemodynamics The data of mean arterial pressure MAP peak heart rate HR SpO2 and ETCO2 were recorded at baseline at 1 minute after induction and then every 5 minutes until the patient went to the recovery unit MAP and HR values were kept at 20 of preoperative values by changing the remifentanil infusion rate Hypotension MAP was defined as 60 mmHg and bradycardia HR as 45 beatsminute and these were treated with noradrenaline 4-8 mcg atropine 05 mg Patients who required noradrenaline or atropine more than twice were excluded from the study
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