Regional Cerebral Oxygen Saturation in Laparoscopic Surgery

Konkuk University Medical Center

Status: Unknown

Conditions: Cholecyctitis

Treatments: Procedure: CO2 insufflation at intra-abdominal pressure 8 mmHg; Procedure: CO2 insufflation at intra-abdominal pressure 12 mmHg

Study type: Interventional

Funder types: Other

Identifiers

NCT02436954

KUH1160084

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• cholecystitis
• provision of written informed consent

Exclusion criteria

• COPD
• asthma
• low LV ejection fraction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

CO2 insufflation at intra-abdominal pressure 8 mmHg

Placebo Comparator group

Description:

CO2 insufflation with intra-abdominal pressure 8 mmHg during deep-NMB

Treatment:

Procedure: CO2 insufflation at intra-abdominal pressure 8 mmHg

CO2 insufflation at intra-abdominal pressure 12 mmHg

Active Comparator group

Description:

CO2 insufflation with intra-abdominal pressure 12 mmHg during deep-NMB

Treatment:

Procedure: CO2 insufflation at intra-abdominal pressure 12 mmHg