NCT06026033

Brief Summary

Desflurane is increasingly used in general anesthesia. Its pharmacokinetic properties are known and its distribution is easily modeled. Yet these models fail in practice. In order to increase accuracy, any model should include cardiac output, alveolar ventilation and alveolar dead space, all of which are either hard to measure or impractical, at least. A previous study performed by the same investigator showed that time to target endtidal concentration of sevoflurane is prolonged with increased cardiac output, but only if the patient has increased muscle mass. Although desflurane has lower muscle and fat solubility, our observations suggest a similar prolongation in case of increased muscle mass. The investigators aim to investigate if patient characteristics such as gender, age, height, weight, body type prolongs time to reach target endtidal desflurane concentration in low flow anesthesia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

March 31, 2023

Last Update Submit

December 18, 2023

Conditions

Keywords

Anesthetics, InhalationAnesthesia, GeneralDesflurane

Outcome Measures

Primary Outcomes (2)

  • Rate of rise in expiratory desflurane concentration

    Correlation between the time required for the endtidal expiratory desflurane concentration to reach 8% and patient characteristics

    intraoperative

  • Rate of rise in inspiratory desflurane concentration

    Correlation between the time required for the endtidal inspiratory desflurane concentration to reach 6% and patient characteristics

    intraoperative

Secondary Outcomes (2)

  • Correlation between occurrence of hypertension and patient characteristics

    intraoperative

  • Correlation between occurrence of tachycardia and patient characteristics

    intraoperative

Study Arms (1)

Patients scheduled for general anesthesia

Patients scheduled for elective general anesthesia will be included, if accepts and signs the informed consent. The inhalational anesthetic should be desflurane. No other inhalational agent should be used during the induction of anesthesia. The inspiratory and expiratory concentration of any inhalational agent should be zero before the induction of anesthesia.

Drug: Desflurane induction

Interventions

Following tracheal intubation, the fresh gas flow will be set to 1 liters/minute, desflurane vaporizer will be set to maximum.

Patients scheduled for general anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients, who are scheduled for elective general anesthesia. Maintenance of anesthesia with desflurane should be included in the routine anesthesia plan.

You may qualify if:

  • age \> 18 years
  • planned elective surgery
  • planned inhalational anesthesia
  • planned use of desflurane

You may not qualify if:

  • emergency surgery
  • use of other inhalational anesthetic agent (sevoflurane, isoflurane, nitrous oxide)
  • disclosed or recognized pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation

Rize, 53100, Turkey (Türkiye)

Location

Related Publications (3)

  • Weber J, Missbach C, Schmidt J, Wenzel C, Schumann S, Philip JH, Wirth S. Prediction of expiratory desflurane and sevoflurane concentrations in lung-healthy patients utilizing cardiac output and alveolar ventilation matched pharmacokinetic models: A comparative observational study. Medicine (Baltimore). 2021 Feb 12;100(6):e23570. doi: 10.1097/MD.0000000000023570.

  • Athiraman U, Ravishankar M, Jahagirdhar S. Performance of computer simulated inhalational anesthetic uptake model in comparison with real time isoflurane concentration. J Clin Monit Comput. 2016 Dec;30(6):791-796. doi: 10.1007/s10877-015-9776-6. Epub 2015 Sep 19.

  • Philip JH. Using screen-based simulation of inhaled anaesthetic delivery to improve patient care. Br J Anaesth. 2015 Dec;115 Suppl 2:ii89-94. doi: 10.1093/bja/aev370.

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Başar Erdivanlı, Assoc. Prof.

    Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation

    STUDY DIRECTOR
  • Alihan Madran, M.D.

    Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

March 31, 2023

First Posted

September 6, 2023

Study Start

February 1, 2022

Primary Completion

August 30, 2023

Study Completion

September 1, 2023

Last Updated

December 22, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations