Regional Cerebral Oxygen Saturation in Laparoscopic Surgery

NCT ID: NCT02436954

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2022-11-30

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.

Conditions

Cholecyctitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CO2 insufflation at intra-abdominal pressure 8 mmHg

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

Group Type: PLACEBO_COMPARATOR

CO2 insufflation at intra-abdominal pressure 8 mmHg

Intervention Type: PROCEDURE

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

CO2 insufflation at intra-abdominal pressure 12 mmHg

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

Group Type: ACTIVE_COMPARATOR

CO2 insufflation at intra-abdominal pressure 12 mmHg

Intervention Type: PROCEDURE

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

Interventions

CO2 insufflation at intra-abdominal pressure 8 mmHg

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

Intervention Type: PROCEDURE

CO2 insufflation at intra-abdominal pressure 12 mmHg

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• cholecystitis
• provision of written informed consent

Exclusion Criteria

• COPD
• asthma
• low LV ejection fraction

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Konkuk University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

KUH1160084

Identifier Type: -

Identifier Source: org_study_id