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Regional Cerebral Oxygen Saturation in Laparoscopic Surgery

Impact of Neuromuscular Blockade on Cerebral Oxygen Saturation in Laparoscopic Surgery Employ Carbon Dioxide-pneumoperitoneum

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02436954
Enrollment
40
Registered
2015-05-07
Start date
2021-11-30
Completion date
2022-11-30
Last updated
2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecyctitis

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.

Interventions

PROCEDURECO2 insufflation at intra-abdominal pressure 8 mmHg

insufflation of CO2 gas into peritoneum for maintaining the pressure of 8 mmHg

PROCEDURECO2 insufflation at intra-abdominal pressure 12 mmHg

insufflation of CO2 gas into peritoneum for maintaining the pressure of 12 mmHg

Sponsors

Konkuk University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* cholecystitis * provision of written informed consent

Exclusion criteria

* COPD * asthma * low LV ejection fraction

Design outcomes

Primary

MeasureTime frameDescription
regional cerebral oxygen saturation 11 min1 min after the initiation of pneumoperitonium
regional cerebral oxygen saturation 22 min2 min after the initiation of pneumoperitonium
regional cerebral oxygen saturation 33 min2 min after the initiation of pneumoperitonium

Secondary

MeasureTime frame
end-tidal carbon dioxide 11 min
repiratory rate3 min
end-tidal carbon dioxide 22 min
end-tidal carbon dioxide 33 min

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026