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Completed

NCT Number: NCT05992636

Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy

Previous studies conducted on the hemodynamic effects of pneumoperitoneum pressures created by different insufflation flows are very limited in the literature. In a current literature review, there was no study found comparing the effects of hemodynamic changes created by low and high insufflation flows and pneumoperitoneum pressure on cerebral oxygenation. The purpose of the study was to contribute to the literature by investigating the effects of pneumoperitoneum pressures created by different flows on brain oxygenation.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karadeniz Technical University

Trabzon, 61080, Turkey (Türkiye)

About this study

After the approval of the Ethics Committee, a total of 69 (sixty-nine) patients who would undergo elective laparoscopic cholecystectomy were planned as ASA I-III, 18-65 years old, 34 (thirty-four) patients low insufflation flow (10 lt/min) and 35 (thirty-five) patients and high insufflation flow (40 lt/min) with pneumoperitoneum pressure.

The study will be conducted as a single-center observational study in Trabzon KTU Faculty of Medicine General Surgery Operating Room. Anesthesia always be performed by the same anesthesia team, and no intervention will be made regarding the choice of the method. The data obtained will be recorded by the anesthetists other than the team who constitute the study group, and the data obtained at the end of the surgery will be interpreted by the study team. The decision for laparoscopic cholecystectomy of the patients who will be included in the study will be made by the General Surgery doctor, and the patients who are scheduled to be operated on electively will be included in the study.

The patients will be taken to the operating room after their written consents are obtained and preoperative evaluations are made, and routine premedication will be applied to the patients who arrive at the operating room. The patients who will be included in the study will be monitored routinely in the general surgery room (i.e. electrocardiography (ECG), non-invasive blood pressure measurement, peripheral oxygen saturation, Bispectral Index (BIS), and additionally NIRS monitoring. No interference will be made regarding the groups in which patients who will undergo general anesthesia will be in the pneumoperitoneum group formed with low insufflation flow or high insufflation flow, only non-invasive cerebral oxygenation measurements will be made with NIRS monitor (INVOS™ 5100C Cerebral/Somatic Oximeter, SOMANETICS, COVIDIEN, Mansfield/ USA)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective laparoscopic cholecystectomy were planned,
  • ASA I-III,
  • 18-65 years old

Exclusion criteria

  • Cerebrovascular diseases and/or intracranial pathologies and/or related neurological events,
  • Uncontrolled diabetes
  • Uncontrolled hypertension
  • Coagulopathy,
  • Cirrhosis and/or peritonitis,
  • Asthma and/or respiratory diseases e.g. COPD,
  • Morbid obesity,
  • Patients with severe organ failure,
  • Emergency cases,
  • Cases converted to laparotomic cholecystectomy.

Treatment and study plan

pneumoperitoneum insufflation (flow) rate

Procedure

Patiens who initiate with low insufflation flow (10 lt/min)

Patiens who initiate with high insufflation flow (40 lt/min)

Primary outcomes

  1. the relationship between insufflation flow rate and cerebral desaturation (rSO2)

    Time frame: 8 months

    With this study, the results of hemodynamic effects on cerebral oxygenation caused by two different insufflation flows (10 lt/min and 40 lt/min) was evaluated by used to create iatrogenic pneumoperitoneum in laparoscopic cholecystectomy surgery with a non-invasive technique, Near Infrared Spectroscopy (NIRS).

    The primary outcome is the investigate to relationship between insufflation flow rate and cerebral desaturation ( which defined by 20% or more decrease in cerebral oxygen saturation compared to baseline value of the patient )

Secondary outcomes

  1. the relationship between insufflation flow rate and end-tidal carbon dioxide value variation (mmHg)

    Time frame: 8 months

    Relationship between insufflation flow rate and end-tidal carbon dioxide value variation of the patients according to basal and before-pnömoperitoneum end-tidal carbon dioxide levels (mmHg) was determined with capnographic measurements.

  2. the relationship between insufflation flow rate and heart rate value variation (beats per minute)

    Time frame: 8 months

    Relationship between insufflation flow rate and heart rate value variation of the patients according to basal and before-pnömoperitoneum heart rate levels was determined with pulse monitoring.

  3. the relationship between insufflation flow rate systolic, diastolic and mean arterial pressure values variation (mmHg)

    Time frame: 8 months

    Relationship between insufflation flow rate and systolic, diastolic and mean arterial pressure (mmHg) values variation of the patients according to basal and before-pnömoperitoneum systolic, diastolic and mean arterial pressure levels were determined with non-invasive blood pressure measurements.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

The Effects of Hemodynamic Changes on Cerebral Oxygenation Caused by Pneumoperitoneum With Different Insufflation Flows in Laparoscopic Cholecystectomy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 15, 2023
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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