Regional Cerebral Oxygen Saturation in Laparoscopic Surgery

August 30, 2021 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • cholecystitis
  • provision of written informed consent

Exclusion Criteria:

  • COPD
  • asthma
  • low LV ejection fraction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
regional cerebral oxygen saturation 1
Time Frame: 1 min
1 min after the initiation of pneumoperitonium
1 min
regional cerebral oxygen saturation 2
Time Frame: 2 min
2 min after the initiation of pneumoperitonium
2 min
regional cerebral oxygen saturation 3
Time Frame: 3 min
2 min after the initiation of pneumoperitonium
3 min

Secondary Outcome Measures

Outcome Measure
Time Frame
end-tidal carbon dioxide 1
Time Frame: 1 min
1 min
end-tidal carbon dioxide 2
Time Frame: 2 min
2 min
end-tidal carbon dioxide 3
Time Frame: 3 min
3 min
repiratory rate
Time Frame: 3 min
3 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

March 18, 2015

First Submitted That Met QC Criteria

May 4, 2015

First Posted (Estimate)

May 7, 2015

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • KUH1160084

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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