Clinical Trials Logo
  1. Home
  2. Pneumoperitoneum
  3. NCT01826955
  4. Details
NCT01826955 Clinical Trial

Effect of Pneumoperitoneum on Cognitive Function and Regional Cerebral Oxygen Saturation

Pneumoperitoneum Clinical Trial

— rSO2pneumo  

Official title:
Effect of Pneumoperitoneum on Cognitive Function and Regional Cerebral Oxygen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01826955
Other study ID # GIRBA2712-2012
Secondary ID
Status Completed
Phase N/A
First received February 2, 2013
Last updated December 22, 2015
Start date April 2013
Est. completion date July 2014

Study information
Verified date December 2015
Source Gachon University Gil Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Gachon University Gil Medical Center Incheon

Sponsors (1)
Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary MMSE 5 days after operation MMSE (mini-mental status exam)was recorded 5days after end of surgery Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06075836 - AI Assisted Detection of Chest X-Rays
Completed NCT03608436 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery Phase 4
Completed NCT03572413 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis. Phase 4
Completed NCT04146090 - Low-pressure vs Standard-pressure in Laparoscopic Cholecystectomy N/A
Completed NCT02853591 - Comparison of Pneumoinsufflation Modes and Pressure Settings in Gynecology N/A
Completed NCT03576118 - Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy N/A
Completed NCT02079337 - Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery Phase 4
Completed NCT01512511 - Comparing Nitrous Oxide and Carbon Dioxide for Laparoscopic Cholecystectomy N/A
Not yet recruiting NCT06116383 - Evaluation of Renal Perfusion With NIRS in Laparoscopic Surgery
Withdrawn NCT03933254 - Intraocular Pressure and Optic Nerve Sheath Diameter Changes in Laparoscopic Cholecystectomies
Recruiting NCT03069586 - Effect Low Pressure Pneumoperitoneum and Pulmonary Recruitment on Postoperative Pain N/A
Recruiting NCT01867814 - Arterial and Plethysmographic Waveforms Variables as Predictors of Hemodynamic Response to Pneumoperitoneum N/A
Terminated NCT01854307 - The Influence of Pneumoperitoneum on Minimal Invasive Cardiac Output Measurements N/A
Recruiting NCT06447545 - Comparison Between Low Pressure Pneumoperitoneum With High Pressure Pneumoperitoneum in Post-operative Pain, Shoulder Tip Pain and Common Bile Duct Injuries in Patients Undergoing Laparoscopic Cholecystectomy N/A
Completed NCT05992636 - Different Insufflation Flows and Effects on Cerebral Oxygenation in Laparoscopic Cholecystectomy
Completed NCT03957837 - Optical Nerve Sheath Changes During Head Down Laparoscopy
Recruiting NCT06319053 - The Turbine-based Insufflator Safety and Feasibility Study N/A
Completed NCT04125173 - Effect of Lower Pneumoperitoneum Pressure During Laparoscopic and Robotic Hysterectomy N/A
Not yet recruiting NCT02690688 - Intra-abdominal Pressure and Dynamic Preload Variables N/A
Completed NCT05238506 - Lidocaine VS Hemodynamic, Metabolic and Hormonal Response Phase 4