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

Regional Cerebral Oxygen Saturation in Laparoscopic Surgery

Sponsors

Lead sponsor: Konkuk University Medical Center

Source 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.

Overall Status Unknown status
Start Date June 2015
Completion Date December 2016
Primary Completion Date December 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
regional cerebral oxygen saturation 1 1 min
regional cerebral oxygen saturation 2 2 min
regional cerebral oxygen saturation 3 3 min
Secondary Outcome
Measure Time Frame
end-tidal carbon dioxide 1 1 min
end-tidal carbon dioxide 2 2 min
end-tidal carbon dioxide 3 3 min
repiratory rate 3 min
Enrollment 40
Condition
Intervention

Intervention type: Procedure

Intervention name: CO2 insufflation at intra-abdominal pressure 8 mmHg

Arm group label: CO2 insufflation at intra-abdominal pressure 8 mmHg

Intervention type: Procedure

Intervention name: CO2 insufflation at intra-abdominal pressure 12 mmHg

Arm group label: CO2 insufflation at intra-abdominal pressure 12 mmHg

Eligibility

Criteria:

Inclusion Criteria:

- cholecystitis

- provision of written informed consent

Exclusion Criteria:

- COPD

- asthma

- low LV ejection fraction

Gender: All

Minimum age: 19 Years

Maximum age: 60 Years

Healthy volunteers: No

Verification Date

June 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Konkuk University Medical Center

Investigator full name: Tae-Yop Kim, MD PhD

Investigator title: Professor of Anesthesiology

Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: CO2 insufflation at intra-abdominal pressure 8 mmHg

Arm group type: Placebo Comparator

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

Arm group label: CO2 insufflation at intra-abdominal pressure 12 mmHg

Arm group type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov