Effect of Pneumoperitoneum on Cognitive Function and Regional Cerebral Oxygen Saturation (rSO2pneumo)

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.

Study Overview

• Status: Completed
• Conditions: Pneumoperitoneum

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Open gastrectomy; patient who undergoing open gastrectomy
laparoscopic gastrectomy; patient who undergoing laparoscopic gastrectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gachon University Gil Medical Center
• Investigators: Study Director: Hyun Jeong Kwak, M.D., Gachon University Gil Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: February 2, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Estimate): December 24, 2015
• Last Update Submitted That Met QC Criteria: December 22, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: pneumoperitoneum, cognitive function
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: GIRBA2712-2012