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Effect of Pneumoperitoneum on Cognitive Function and Regional Cerebral Oxygen Saturation

NCT ID: NCT01826955

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-07-31

Brief Summary

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The investigators hypothesized that the pneumoperitoneum with reverse Trendelenburg position could alter the rSO2 and early postoperative cognitive function.

Detailed Description

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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

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Pneumoperitoneum

Keywords

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pneumoperitoneum, cognitive function

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Open gastrectomy

patient who undergoing open gastrectomy

No interventions assigned to this group

laparoscopic gastrectomy

patient who undergoing laparoscopic gastrectomy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hyun Jeong Kwak

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyun Jeong Kwak, M.D.

Role: STUDY_DIRECTOR

Gachon University Gil Medical Center

Locations

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Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 18848109 (View on PubMed)

Other Identifiers

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GIRBA2712-2012

Identifier Type: -

Identifier Source: org_study_id