Modeling the Effect of EtCO2 on Cerebral Oxygenation

February 10, 2015 updated by: So Yeon Kim, Severance Hospital

Pharmacodynamic Modeling of the Effect of End-tidal Carbon Dioxide on Cerebral Oxygen Saturation in Beach Chair Position Under General Anesthesia

The aim of this study was to investigate the relationship between the end-tidal carbon dioxide (EtCO2) and cerebral oxygen saturation (rSO2) and to identify the covariates in the pharmacodynamic relationship between EtCO2 and rSO2.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Even though mild hypercapnia in the beach chair position (BCP) under general anesthesia was effective in reducing cerebral desaturation, there is no comprehensive data with regard to the dose-effect relationship of EtCO2 on rSO2 in the BCP under general anesthesia. Pharmacodynamic modeling can be useful in describing this relationship in which concurrent mean arterial pressure changes and disease state can be considered as covariates. Therefore, we investigated the relationship between the EtCO2 and rSO2 and identified the covariates in the pharmacodynamic relationship between EtCO2 and rSO2.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥19 years who were scheduled to elective arthroscopic shoulder surgery in BCP under general anesthesia

Exclusion Criteria:

  • Previous cerebrovascular disease, orthostatic hypotension, and the American Society of Anesthesiologists physical status IV or V

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Change of EtCO2
Changes of rSO2 after adjustment of EtCO2 between 27-45 mmHg
Other: EtCO2
Initial data collection during BCP was performed following three conditions were satisfied: after start of surgery; at least 15 min after BCP (for stabilization of MAP); after ventilation frequency was adjusted to produce EtCO2 of 27-29 mmHg with tidal volume of 8 ml/kg. Data was collected every 3 min after decreasing ventilation frequency by 1-2 breaths/min to increase EtCO2 until 42-45 mmHg. Once the value of EtCO2 42-45 mmHg was reached, ventilator frequency was increased in the same way to decrease EtCO2 until 27-29 mmHg. Fraction of inspired oxygen of 50% was maintained and end-tidal desflurane concentration was adjusted to achieve bispectral index values of 40-55 during data collection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The parameters of indirect response model
Time Frame: 60 min
fractional turnover rate (kout), baseline rSO2, baseline EtCO2, linear slope governing the relation between EtCO2 and rSO2
60 min
The factors that influence the model parameters
Time Frame: 60 min
mean blood pressure, end-tidal desflurane concentration, age, sex, hypertention, diabetes mellitus, weight
60 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Severance Hospital

Investigators

  • Principal Investigator: Dong Woo Han, MD, PhD, Severance hospital, Yonsei university college of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 6, 2014

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 4-2014-0688

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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