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Modeling the Effect of EtCO2 on Cerebral Oxygenation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02284763
Enrollment
55
Registered
2014-11-06
Start date
2014-10-31
Completion date
2015-01-31
Last updated
2015-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Surgery

Brief summary

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.

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.

Interventions

OTHEREtCO2

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.

Sponsors

Severance Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The parameters of indirect response model60 minfractional turnover rate (kout), baseline rSO2, baseline EtCO2, linear slope governing the relation between EtCO2 and rSO2
The factors that influence the model parameters60 minmean blood pressure, end-tidal desflurane concentration, age, sex, hypertention, diabetes mellitus, weight

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026