Regional Cerebral Oxygen Saturation in Laparoscopic Surgery

Sponsor

Konkuk University Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02436954

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholecyctitis	Procedure: CO2 insufflation at intra-abdominal pressure 8 mmHg Procedure: CO2 insufflation at intra-abdominal pressure 12 mmHg	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: CO2 insufflation at intra-abdominal pressure 8 mmHg CO2 insufflation with intra-abdominal pressure 8 mmHg during deep-NMB	Procedure: CO2 insufflation at intra-abdominal pressure 8 mmHg insufflation of CO2 gas into peritoneum for maintaining the pressure of 8 mmHg
Active Comparator: CO2 insufflation at intra-abdominal pressure 12 mmHg CO2 insufflation with intra-abdominal pressure 12 mmHg during deep-NMB	Procedure: CO2 insufflation at intra-abdominal pressure 12 mmHg insufflation of CO2 gas into peritoneum for maintaining the pressure of 12 mmHg

Arm

Intervention/Treatment

Placebo Comparator: CO2 insufflation at intra-abdominal pressure 8 mmHg

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

Procedure: CO2 insufflation at intra-abdominal pressure 8 mmHg

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

Active Comparator: CO2 insufflation at intra-abdominal pressure 12 mmHg

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

Procedure: CO2 insufflation at intra-abdominal pressure 12 mmHg

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

Outcome Measures

Primary Outcome Measures

regional cerebral oxygen saturation 1 [1 min]
1 min after the initiation of pneumoperitonium
regional cerebral oxygen saturation 2 [2 min]
2 min after the initiation of pneumoperitonium
regional cerebral oxygen saturation 3 [3 min]
2 min after the initiation of pneumoperitonium

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

cholecystitis
provision of written informed consent

Exclusion Criteria:

COPD
asthma
low LV ejection fraction

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Konkuk University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center

ClinicalTrials.gov Identifier:

NCT02436954

Other Study ID Numbers:

KUH1160084

First Posted:

May 7, 2015

Last Update Posted:

Sep 2, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 2, 2021