Pneumoperitoneum and Cerebral Oxygenation

Cerebral Oxygen Saturation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671121
• Other study ID #: B.30.2.ODM.0.20.08/1725
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: December 2020
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Oxygen Saturation
• Laparoscopic Nephrectomy
• Pneumoperitoneum

Intervention

Procedure:
• Standart pressure pneumoperitoneum
CO2 insufflation pressure was kept at 14 mmHg throughout the surgery.
• Low pressure pneumoperitoneum
CO2 insufflation pressure was kept at 8 mmHg throughout the surgery.

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis Universitesi	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

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. — View 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. — View 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. — View 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. Review. — View Citation

Özdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warlé 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 — View 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.0 — View 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. — View 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. — View 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.2014.10.00 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional cerebral oxygen saturation (rSO2)	The rSO2 measurements were made using the near-infrared spectroscopy (NIRS) method. For this, prior to induction, the cerebral oximetry sensor was placed at least 2 cm above the eyebrows and 3 cm from the midline in accordance with the manufacturer's instructions. Measurements were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient went to the recovery unit. Baseline values were accepted as measurements in the last 30 seconds of preoxygenation for 3 minutes with 80% oxygen before induction. Cerebral desaturation was defined as a decrease in the rSO2 value of more than 25% from the baseline value (if the baseline value is <50, the decrease should be more than 20%), with this condition lasting =15 seconds.	The rSO2 value changes were recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
Primary	Arterial Blood Gas (ABG) analysis-pH	The pH value was measured 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.	The pH values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 minutes.
Primary	Arterial blood gas analysis: partial pressure of oxygen (PO2)	The PO2 value was measured 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.	The oxygen partial pressure values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 minutes.
Primary	Arterial blood gas analysis: partial pressure of carbon dioxide (PCO2)	The PCO2 value was measured 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.	The carbon dioxide partial pressure values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 minutes.
Primary	Arterial blood gas analysis: Hemoglobin (Hg) value	The Hg value was measured 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.	The hemoglobin values of the patients were recorded after anesthesia induction until 10 minutes after desufflation, up to 140 min.
Secondary	The mean arterial pressure (MAP) values	The data of the mean arterial pressure were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit.	The mean arterial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
Secondary	The heart rate (HR) values	The data of heart rate were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit.; The MAP and HR values were kept at ±20% of the preoperative values by changing the remifentanil infusion rate. Hypotension MAP was defined as <60 mmHg and bradycardia HR as 45 beats/minute, and were treated with noradrenaline 4-8 mcg and atropine 0.5 mg. Patients who required noradrenaline or atropine more than twice were excluded from the study.	The heart rate was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
Secondary	Peripheral oxygen saturation (SPO2) values	The SPO2 data were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit.	The oxygen saturation was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.
Secondary	Anesthesia time (min)	The duration of anesthesia was defined as the time the patient was under anesthesia.	Anesthesia time was recorded during each operation.
Secondary	Surgical Time (min)	Surgical time was defined as the time elapsed from the time the trocar insertion was completed until the surgery was completed and the trocars were removed.	Surgical time was recorded during each operation.
Secondary	Pneumoperitoneum Time (min)	This was defined as the time during which pneumoperitoneum was administered to the patient.	The pneumoperitoneum time was recorded during each operation.
Secondary	End-tidal carbon dioxide values (EtCO2) values	The data for EtCO2 were recorded at baseline, at 1 minute after induction, and then every 5 minutes until the patient was referred to the recovery unit.	The end-tidal carbon dioxide partial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 160 min
Secondary	Lateral Semi-oblique Position Time (min)	This was defined as the time the patient stayed in the lateral semi-oblique position.	The lateral semi-oblique position time was recorded during each operation.
Secondary	Recovery Time (min)	The recovery time was defined as the time from discontinuation of sevoflurane and remifentanil to extubation at the end of the surgical procedure.	The recovery time was recorded from the end of the surgery to extubation.