Clinical trial NCT04671121: Pneumoperitoneum and Cerebral Oxygenation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Nephrectomy
Cerebral Oxygen Saturation
Keywords: Pneumoperitoneum
Spectroscopy
Near-infrared
Oximetry
Brain
Nephrectomy
Surgery
Laparoscopic
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were randomly classified into 2 groups. The patients given the low-pressure pneumoperitoneum (8 mmHg) treatment were called Group LP (n = 30), and the patients given the standard pressure treatment (14 mmHg) were called Group SP (n = 30). Each patient and the anesthesiologist responsible for that patient's anesthesia management were blinded to the group assignments.
Primary purpose: SUPPORTIVE_CARE

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 (1.5-2.5 mg/kg) and remifentanil (1 mcg/kg IV bolus for 30-60 seconds, then 0.25 mcg/kg/min), and rocuronium (1.2 mg/kg). Anesthesia was maintained with O2/Air (fraction of inspired oxygen of 0.40; inspiratory fresh gas flow of 2 L/min), sevoflurane (1 minimum alveolar concentration), and remifentanil IV infusion (0.1-0.25 mcg/kg/min). 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 mL/kg, inspirium/exprium expiratory ratio 1:2, 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 (0.3-0.4 mg/kg/hour) with a post-tetanic count of zero. At the end of the case, extubation was provided by decurarizing the rocuronium with a combination of 0.02mg/kg atropine and 0.04 mg/kg 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 beats/minute, and these were treated with noradrenaline 4-8 mcg, atropine 0.5 mg. Patients who required noradrenaline or atropine more than twice were excluded from the study.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for laparoscopic nephrectomy (simple, partial, or radical)
* The American Society of Anesthesiologists (ASA) physical status class I-III

Exclusion Criteria:

* Cerebrovascular diseases
* Neurological disorders
* Uncontrolled diabetes or hypertension
* Advanced organ failure
* Baseline peripheral oxygen saturation (SpO2) less than 96%
* Patients with hemoglobin \<9 g/dL

Primary outcomes:
measure: Regional cerebral oxygen saturation (rSO2)
timeFrame: The rSO2 value changes were recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
measure: Arterial Blood Gas (ABG) analysis-pH
timeFrame: The pH values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 minutes.
measure: Arterial blood gas analysis: partial pressure of oxygen (PO2)
timeFrame: The oxygen partial pressure values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 minutes.
measure: Arterial blood gas analysis: partial pressure of carbon dioxide (PCO2)
timeFrame: The carbon dioxide partial pressure values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 minutes.
measure: Arterial blood gas analysis: Hemoglobin (Hg) value
timeFrame: The hemoglobin values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 min.
Secondary outcomes:
measure: The mean arterial pressure (MAP) values
timeFrame: The mean arterial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
measure: The heart rate (HR) values
timeFrame: The heart rate was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
measure: Peripheral oxygen saturation (SPO2) values
timeFrame: The oxygen saturation was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
measure: Anesthesia time (min)
timeFrame: Anesthesia time was recorded during each operation.
measure: Surgical Time (min)
timeFrame: Surgical time was recorded during each operation.
measure: Pneumoperitoneum Time (min)
timeFrame: The pneumoperitoneum time was recorded during each operation.
measure: End-tidal carbon dioxide values (EtCO2) values
timeFrame: The end-tidal carbon dioxide partial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 160 min
measure: Lateral Semi-oblique Position Time (min)
timeFrame: The lateral semi-oblique position time was recorded during each operation.
measure: Recovery Time (min)
timeFrame: The recovery time was recorded from the end of the surgery to extubation.
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University
name: Cengiz Kaya
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gipson CL, Johnson GA, Fisher R, Stewart A, Giles G, Johnson JO, Tobias JD. Changes in cerebral oximetry during peritoneal insufflation for laparoscopic procedures. J Minim Access Surg. 2006 Jun;2(2):67-72. doi: 10.4103/0972-9941.26651.
citation: Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.
citation: de Waal EE, de Vries JW, Kruitwagen CL, Kalkman CJ. The effects of low-pressure carbon dioxide pneumoperitoneum on cerebral oxygenation and cerebral blood volume in children. Anesth Analg. 2002 Mar;94(3):500-5; table of contents. doi: 10.1097/00000539-200203000-00005.
citation: Tuna AT, Akkoyun I, Darcin S, Palabiyik O. Effects of carbon dioxide insufflation on regional cerebral oxygenation during laparoscopic surgery in children: a prospective study. Braz J Anesthesiol. 2016 May-Jun;66(3):249-53. doi: 10.1016/j.bjane.2014.10.004. Epub 2015 May 12.
citation: Pelizzo G, Bernardi L, Carlini V, Pasqua N, Mencherini S, Maggio G, De Silvestri A, Bianchi L, Calcaterra V. Laparoscopy in children and its impact on brain oxygenation during routine inguinal hernia repair. J Minim Access Surg. 2017 Jan-Mar;13(1):51-56. doi: 10.4103/0972-9941.181800.
citation: Oztan MO, Aydin G, Cigsar EB, Sutas Bozkurt P, Koyluoglu G. Effects of Carbon Dioxide Insufflation and Trendelenburg Position on Brain Oxygenation During Laparoscopy in Children. Surg Laparosc Endosc Percutan Tech. 2019 Apr;29(2):90-94. doi: 10.1097/SLE.0000000000000593.
citation: Park EY, Koo BN, Min KT, Nam SH. The effect of pneumoperitoneum in the steep Trendelenburg position on cerebral oxygenation. Acta Anaesthesiol Scand. 2009 Aug;53(7):895-9. doi: 10.1111/j.1399-6576.2009.01991.x. Epub 2009 May 6.
citation: Lee JR, Lee PB, Do SH, Jeon YT, Lee JM, Hwang JY, Han SH. The effect of gynaecological laparoscopic surgery on cerebral oxygenation. J Int Med Res. 2006 Sep-Oct;34(5):531-6. doi: 10.1177/147323000603400511.
citation: Nasrallah G, Souki FG. Perianesthetic Management of Laparoscopic Kidney Surgery. Curr Urol Rep. 2018 Jan 18;19(1):1. doi: 10.1007/s11934-018-0757-4.