CholecyctitisNCT02436954
Regional Cerebral Oxygen Saturation in Laparoscopic Surgery
A study testing CO2 insufflation at intra-abdominal pressure 8 mmHg and CO2 insufflation at intra-abdominal pressure 12 mmHg in people with Cholecyctitis, run by Konkuk University Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Cholecyctitis
- What is being tested?
- CO2 insufflation at intra-abdominal pressure 8 mmHg and CO2 insufflation at intra-abdominal pressure 12 mmHg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- cholecystitis
- provision of written informed consent
Who cannot join
- COPD
- asthma
- low LV ejection fraction
About this study
Official title: 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.
- Conditions
- Cholecyctitis
- Being tested
- CO2 insufflation at intra-abdominal pressure 8 mmHg, CO2 insufflation at intra-abdominal pressure 12 mmHg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 insufflation at intra-abdominal pressure 8 mmHgProcedure or surgery
insufflation of CO2 gas into peritoneum for maintaining the pressure of 8 mmHg
CO2 insufflation at intra-abdominal pressure 12 mmHgProcedure or surgery
insufflation of CO2 gas into peritoneum for maintaining the pressure of 12 mmHg
| Study group | Role | What they receive |
|---|---|---|
| CO2 insufflation at intra-abdominal pressure 8 mmHg | Placebo comparator | CO2 insufflation with intra-abdominal pressure 8 mmHg during deep-NMB Receives: Procedure: CO2 insufflation at intra-abdominal pressure 8 mmHg |
| CO2 insufflation at intra-abdominal pressure 12 mmHg | Active comparator | CO2 insufflation with intra-abdominal pressure 12 mmHg during deep-NMB Receives: Procedure: CO2 insufflation at intra-abdominal pressure 12 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
regional cerebral oxygen saturation 1
1 min after the initiation of pneumoperitonium
Measured: 1 min
regional cerebral oxygen saturation 2
2 min after the initiation of pneumoperitonium
Measured: 2 min
regional cerebral oxygen saturation 3
2 min after the initiation of pneumoperitonium
Measured: 3 min
Secondary outcomes (4)
end-tidal carbon dioxide 1
Measured: 1 min
end-tidal carbon dioxide 2
Measured: 2 min
end-tidal carbon dioxide 3
Measured: 3 min
repiratory rate
Measured: 3 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startNov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecyctitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436954
- Sponsor's protocol ID
- KUH1160084
- Status last verified
- Aug 2021
- First submitted
- 18 Mar 2015
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Neuromuscular Blockade on Cerebral Oxygen Saturation in Laparoscopic Surgery Employ Carbon Dioxide-pneumoperitoneum
- ClinicalTrials.gov ID
- NCT02436954
- Acronym / sponsor ID
- KUH1160084
- Conditions
- Cholecyctitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO2 insufflation at intra-abdominal pressure 8 mmHg | Placebo comparator | Procedure: CO2 insufflation at intra-abdominal pressure 8 mmHgCO2 insufflation with intra-abdominal pressure 8 mmHg during deep-NMB |
| CO2 insufflation at intra-abdominal pressure 12 mmHg | Active comparator | Procedure: CO2 insufflation at intra-abdominal pressure 12 mmHgCO2 insufflation with intra-abdominal pressure 12 mmHg during deep-NMB |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- cholecystitis
- provision of written informed consent
Key exclusion criteria (3 listed)
- COPD
- asthma
- low LV ejection fraction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 insufflation at intra-abdominal pressure 8 mmHginsufflation of CO2 gas into peritoneum for maintaining the pressure of 8 mmHg | Procedure or surgery | CO2 insufflation at intra-abdominal pressure 8 mmHg |
| CO2 insufflation at intra-abdominal pressure 12 mmHginsufflation of CO2 gas into peritoneum for maintaining the pressure of 12 mmHg | Procedure or surgery | CO2 insufflation at intra-abdominal pressure 12 mmHg |
Primary outcome
regional cerebral oxygen saturation 1
Time frame: 1 min
1 min after the initiation of pneumoperitonium
regional cerebral oxygen saturation 2
Time frame: 2 min
2 min after the initiation of pneumoperitonium
regional cerebral oxygen saturation 3
Time frame: 3 min
2 min after the initiation of pneumoperitonium
4 secondary outcomes
end-tidal carbon dioxide 1
Time frame: 1 min
end-tidal carbon dioxide 2
Time frame: 2 min
end-tidal carbon dioxide 3
Time frame: 3 min
repiratory rate
Time frame: 3 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 insufflation at intra-abdominal pressure 8 mmHg and CO2 insufflation at intra-abdominal pressure 12 mmHg in people with Cholecyctitis, run by Konkuk University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
regional cerebral oxygen saturation 1 (time frame: 1 min). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.