Regional Cerebral Oxygen Saturation in Laparoscopic Surgery

Not Applicable

• Conditions: Cholecyctitis
• Interventions: Procedure: CO2 insufflation at intra-abdominal pressure 12 mmHg; Procedure: CO2 insufflation at intra-abdominal pressure 8 mmHg

• Registration Number: NCT02436954
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

While few studies have determined the optimal intra-abdominal CO2 insufflation pressure to achieve optimal surgical condition during LCs with deep-NMB and moderate-NMB in laparoscopic cholecystectomy (LC), previous studies suggested that the use of deep neuromuscular blockade (deep-NMB) can improve surgical condition and reduce the pressure for CO2 insufflation to achieve "optimal surgical space condition".

this difference in the pressure of intra-abdominal CO2 insufflation due to different strategies employing deep-NMB and moderate-NMB for LC may produce possible difference in patient's respiratory pattern and cerebral oxygenation. Although previous study (studies) showed that intra-abdominal CO2 insufflation (10-12 mmHg) decreases cerebral oxy-hemoglobin (HbO2) and total Hb measured by near-infrared spectroscopy (NIRS) during laparoscopic cholecystectomy (LC), few studies have speculated possible impact of different degree of NMB and intra-abdominal CO2 insufflation pressure on patient's cardiorespiratory profile and cerebral oxygenation, so far.

The present study determines and compares the changes CO2 absorption and cerebral oxygenation (cerebral perfusion) after applying CO2 insufflation with different intra-peritoneal pressure 8 vs 12 mmHg during deep-NMB.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-05-04
• Study First Posted: 2015-05-07
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-02
• Study Start: 2021-11
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• cholecystitis
• provision of written informed consent

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Exclusion Criteria

• COPD
• asthma
• low LV ejection fraction

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CO2 insufflation at intra-abdominal pressure 12 mmHg	CO2 insufflation at intra-abdominal pressure 12 mmHg	CO2 insufflation with intra-abdominal pressure 12 mmHg during deep-NMB
CO2 insufflation at intra-abdominal pressure 8 mmHg	CO2 insufflation at intra-abdominal pressure 8 mmHg	CO2 insufflation with intra-abdominal pressure 8 mmHg during deep-NMB

Primary Outcome Measures

Name	Time	Method
regional cerebral oxygen saturation 2	2 min	2 min after the initiation of pneumoperitonium
regional cerebral oxygen saturation 1	1 min	1 min after the initiation of pneumoperitonium
regional cerebral oxygen saturation 3	3 min	2 min after the initiation of pneumoperitonium

Secondary Outcome Measures

Name	Time	Method
repiratory rate	3 min
end-tidal carbon dioxide 2	2 min
end-tidal carbon dioxide 3	3 min
end-tidal carbon dioxide 1	1 min