Pneumoperitoneum and Cerebral Oxygenation

NCT04671121 | Completed

• 1 other identifier: B.30.2.ODM.0.20.08/1725
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Nephrectomy; Cerebral Oxygen Saturation

Keywords

Pneumoperitoneum; Spectroscopy; Near-infrared; Oximetry; Brain; Nephrectomy; Surgery; Laparoscopic

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (9)

• The mean arterial pressure (MAP) values

  The mean arterial pressure was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.

• The heart rate (HR) values

  The heart rate was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.

• Peripheral oxygen saturation (SPO2) values

  The oxygen saturation was recorded from baseline until the patient was referred to the recovery unit, up to 160 minutes.

• Anesthesia time (min)

  Anesthesia time was recorded during each operation.

• Surgical Time (min)

  Surgical time was recorded during each operation.

Study Arms (2)

Grup LP (n = 31)

ACTIVE COMPARATOR

CO2 insufflation pressure was kept at 8 mmHg throughout the surgery.

Procedure: Low pressure pneumoperitoneum

Grup SP (n = 31)

ACTIVE COMPARATOR

CO2 insufflation pressure was kept at 14 mmHg throughout the surgery.

Procedure: Standart pressure pneumoperitoneum

Interventions

Standart pressure pneumoperitoneum PROCEDURE

CO2 insufflation pressure was kept at 14 mmHg throughout the surgery.

Grup SP (n = 31)

Low pressure pneumoperitoneum PROCEDURE

CO2 insufflation pressure was kept at 8 mmHg throughout the surgery.

Grup LP (n = 31)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis Universitesi

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (9)

• 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.

  PMID: 21170237 RESULT

• 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.

  PMID: 26275545 RESULT

• 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.

  PMID: 11867365 RESULT

• 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.

  PMID: 27108820 RESULT

• 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.

  PMID: 27251842 RESULT

• 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.

  PMID: 30395045 RESULT

• 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.

  PMID: 19426238 RESULT

• 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.

  PMID: 17133783 RESULT

• 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.

  PMID: 29349580 RESULT

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Cengiz Kaya

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients were randomly classified into 2 groups using opaque sealed envelopes. Randomization was performed using a computer-generated random number list, and a statement indicating the patient's group was placed in a closed envelope numbered according to the result. Each patient was asked to choose an envelope, and the patients were assigned to the study according to the group written in the envelope.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AssociateProfessor, MD

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: January 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: December 19, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)