PneumoperitoneumrSO2pneumoNCT01826955
Effect of Pneumoperitoneum on Cognitive Function and Regional Cerebral Oxygen Saturation
An observational study of Pneumoperitoneum, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
The investigators hypothesized that the pneumoperitoneum with reverse Trendelenburg position could alter the rSO2 and early postoperative cognitive function. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Pneumoperitoneum
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Jul 2014
- How long will I take part?
- 5 Days
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who undergoing laparosopic or open gastrectomy patients who have respiratory and cardiovascular disorders were excluded
Who may be able to join
- ASA class I or II, aged 20 to 70 yrs
Who cannot join
- Patients with morbid obesity (body mass index > 30 kg/m2) or a history of cerebrovascular or respiratory disease were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pneumoperitoneum on Cognitive Function and Regional Cerebral Oxygen
The investigators hypothesized that the pneumoperitoneum with reverse Trendelenburg position could alter the rSO2 and early postoperative cognitive function.
Read the detailed description
Laparoscopic gastrectomy requires a reverse-Trendelenburg position and prolonged pneumoperitoneum and it could cause significant changes in cerebral homeostasis and lead to cognitive dysfunction. We compared changes in haemodynamic variables, regional cerebral oxygen saturation, and early postoperative cognitive function in patients undergoing laparoscopic gastrectomy in the reverse Trendelenburg position with those patients that underwent conventional open gastrectomy.
- Conditions
- Pneumoperitoneum
- Keywords
- pneumoperitoneum, cognitive function
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Open gastrectomy | patient who undergoing open gastrectomy | |
| laparoscopic gastrectomy | patient who undergoing laparoscopic gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMSE
5 days after operation MMSE (mini-mental status exam)was recorded
Measured: 5days after end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoperitoneumStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun Jeong Kwak, Gachon University Gil Medical Center
- Investigators
- Hyun Jeong Kwak, M.D., Study director, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826955
- Sponsor's protocol ID
- GIRBA2712-2012
- Acronym
- rSO2pneumo
- Status last verified
- Dec 2015
- First submitted
- 2 Feb 2013
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choi SH, Lee SJ, Jung YS, Shin YS, Jun DB, Hwang KH, Liu J, Kim KJ. Nitroglycerin- and nicardipine-induced hypotension does not affect cerebral oxygen saturation and postoperative cognitive function in patients undergoing orthognathic surgery. J Oral Maxillofac Surg. 2008 Oct;66(10):2104-9. doi: 10.1016/j.joms.2008.06.041.
PubMed 18848109
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pneumoperitoneum on Cognitive Function and Regional Cerebral Oxygen
- ClinicalTrials.gov ID
- NCT01826955
- Acronym / sponsor ID
- rSO2pneumo / GIRBA2712-2012
- Conditions
- Pneumoperitoneum
- Keywords
- pneumoperitoneum, cognitive function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 9 Apr 2013 (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.
The investigators hypothesized that the pneumoperitoneum with reverse Trendelenburg position could alter the rSO2 and early postoperative cognitive function.
Detailed description
Laparoscopic gastrectomy requires a reverse-Trendelenburg position and prolonged pneumoperitoneum and it could cause significant changes in cerebral homeostasis and lead to cognitive dysfunction. We compared changes in haemodynamic variables, regional cerebral oxygen saturation, and early postoperative cognitive function in patients undergoing laparoscopic gastrectomy in the reverse Trendelenburg position with those patients that underwent conventional open gastrectomy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open gastrectomy | – | –patient who undergoing open gastrectomy |
| laparoscopic gastrectomy | – | –patient who undergoing laparoscopic gastrectomy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who undergoing laparosopic or open gastrectomy patients who have respiratory and cardiovascular disorders were excluded
Key inclusion criteria (1 listed)
- ASA class I or II, aged 20 to 70 yrs
Key exclusion criteria (1 listed)
- Patients with morbid obesity (body mass index > 30 kg/m2) or a history of cerebrovascular or respiratory disease were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MMSE
Time frame: 5days after end of surgery
5 days after operation MMSE (mini-mental status exam)was recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Background: PubMed 18848109Choi SH, Lee SJ, Jung YS, Shin YS, Jun DB, Hwang KH, Liu J, Kim KJ. Nitroglycerin- and nicardipine-induced hypotension does not affect cerebral oxygen saturation and postoperative cognitive function in patients undergoing orthognathic surgery. J Oral Maxillofac Surg. 2008 Oct;66(10):2104-9. doi: 10.1016/j.joms.2008.06.041.
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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.
Hyun Jeong Kwak, M.D. study director
Gachon University Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumoperitoneum, run by Gachon University Gil Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MMSE (time frame: 5days after end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01826955, which also lists 1 linked publication.
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 24 Dec 2015.