Effect of Pneumoperitoneum on Cognitive Function and Regi... | NCT01826955

Studies
Effect of Pneumoperitoneum on Cognitive Function and Regional Cerebral Oxygen Saturation

NCT01826955

Sponsor

Gachon University Gil Medical Center

Status

Completed

Last Update Posted

Dec 24, 2015Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Pneumoperitoneum

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Feb 2, 2013

First Submission Date that Met QC Criteria

Apr 4, 2013

First Posted Date

Apr 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2015

Last Update Posted Date

Dec 24, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyun Jeong Kwak, Associate professor, Gachon University Gil Medical CenterPrincipal Investigator

Lead Sponsor

Gachon University Gil Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open gastrectomy		patient who undergoing open gastrectomy
laparoscopic gastrectomy		patient who undergoing laparoscopic gastrectomy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MMSE	5 days after operation MMSE (mini-mental status exam)was recorded	5days after end of surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA class I or II, aged 20 to 70 yrs

Exclusion Criteria:

Patients with morbid obesity (body mass index > 30 kg/m2) or a history of cerebrovascular or respiratory disease were excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patient who undergoing laparosopic or open gastrectomy patients who have respiratory and cardiovascular disorders were excluded

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hyun Jeong Kwak, M.D.	Gachon University Gil Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gachon University Gil Medical Center		Incheon			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18848109	Background	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.

ID	Term
D010532	Peritoneal Diseases
D004066	Digestive System Diseases