Effect of Pneumoperitoneum on the Continuous and Non-invasive Hemoglobin Monitoring

Effect of Pneumoperitoneum on the Continuous and Non-invasive Hemoglobin Monitoring for Laparoscopic Gastrectomy: a Randomized Controlled Study

The primary purpose of this study is to investigate the effect of pneumoperitoneum on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy

Study Overview

• Status: Completed
• Conditions: Gastric Cancer
• Intervention / Treatment: Other: High end-tidal CO2; Other: Low CO2 group

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoum
    • Suwon, Seoum, Korea, Republic of
      • Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Laparoscopic gastrectomy under general anesthesia

Exclusion Criteria:

• atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High CO2 group; end tidal CO2 : 40-45 mmHg	Other: High end-tidal CO2; maintaining of end-tidal CO2 with the range of 40-45 mmHg
Placebo Comparator: Low CO2 group; end tidal CO2 : 30-35 mmHg	Other: Low CO2 group; maintaining of end-tidal CO2 with the range of 30-35 mmHg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference between SpHb value and SaHb value (SpHb - SaHb)	SpHb value is measured by co-oxymetry, and SaHb value is measured by blood sampling.	from the start of anesthesia to the end of anesthesia, an average 2 hours

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): May 13, 2019
• Study Completion (Actual): May 13, 2019

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 17, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: AJIRB-MED-OBS-17-339

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No