Effects of the breathing response during reduced oxygen tension and simultaneous infusion of dexmedetomidine compared to propofol, two sedating agents.

Acute ventilatory response to hypoxia during sedation with dexmedetomidine compared to propofol in healthy volunteers.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005812-24-SE

Enrollment

Registered

2013-03-01

Start date

2013-05-02

Completion date

Unknown

Last updated

2014-10-27

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

Conditions

Healthy volunteers and the acute hypoxic ventilatory response during sedation with dexmedetomidine compared to propofol. MedDRA version: 14.1 Level: LLT Classification code 10068084 Term: Anesthesia procedure System Organ Class: 100000004865 MedDRA version: 14.1 Level: LLT Classification code 10062825 Term: Monitored anaesthesia care sedation System Organ Class: 100000004865

Interventions

Trade Name: Dexdor Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 113775-47-6 Other descriptive name: dexmedetomidine Concentration unit: µ

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy male volunteers 18-40 years of age. No allergy or medication. Non-smokers, non-tobacco user. Normal weight, that is BMI=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Those who do not fulfill the inclusion criteria. Snoring during sleep. A beard or anatomy that unables the breathing mask to fit tightly.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. Does dexmedetomidine affect the acute hypoxic ventilatory response in healthy volunteers? 2. Is the acute hypoxic ventilatory response in healthy volunteers less affected with dexmedetomidine than propofol at the same level of sedation?;Secondary Objective: 1. Does dexmedetomidine affect the acute hypercapnic ventilatory response in healthy volunteers? 2. Is the acute hypercapnic ventilatory response in healthy volunteers less affected dexmedetomidine than propofol at the same level of sedation? 3. Are there signs of an obstructed airway during sedation with dexmedetomidine or propofol? 4. How does the plasma concentration of dexmedetomidine and propofol correlate to the level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S) and Richmond Agitation Sedation Score (RASS)? 5. How does the level of sedation according to (OAA/S) correlate to (RASS) during dexmedetomidine and propofol infusion? 6. Does the level of sedation according to OAA/S and RASS correlate to BIS during sedation with dexmedetomidine and propofol?;Primary end point(s): Hypoxic ventilatory response. That is the change of minute ventilation (VE) divided by the change in saturation (SpO2).;Timepoint(s) of evaluation of this end point: When the second breathing test is done and the acute hypoxic ventilatory response has been measured during infusion of dexmedetomidine to achieve a moderate level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S).	—

Measure

Time frame

Main Objective: 1. Does dexmedetomidine affect the acute hypoxic ventilatory response in healthy volunteers? 2. Is the acute hypoxic ventilatory response in healthy volunteers less affected with dexmedetomidine than propofol at the same level of sedation?;Secondary Objective: 1. Does dexmedetomidine affect the acute hypercapnic ventilatory response in healthy volunteers? 2. Is the acute hypercapnic ventilatory response in healthy volunteers less affected dexmedetomidine than propofol at the same level of sedation? 3. Are there signs of an obstructed airway during sedation with dexmedetomidine or propofol? 4. How does the plasma concentration of dexmedetomidine and propofol correlate to the level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S) and Richmond Agitation Sedation Score (RASS)? 5. How does the level of sedation according to (OAA/S) correlate to (RASS) during dexmedetomidine and propofol infusion? 6. Does the level of sedation according to OAA/S and RASS correlate to BIS during sedation with dexmedetomidine and propofol?;Primary end point(s): Hypoxic ventilatory response. That is the change of minute ventilation (VE) divided by the change in saturation (SpO2).;Timepoint(s) of evaluation of this end point: When the second breathing test is done and the acute hypoxic ventilatory response has been measured during infusion of dexmedetomidine to achieve a moderate level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S).

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Secondary

Measure	Time frame
Secondary end point(s): Hypercapnic ventilatory respons. Respiratory rate. Tidal volume. Airway flow. Thoracic and abdominal impedance. Oxygen saturation. Level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S), Richmond Agitation Sedation Score (RASS) and bispectral index (BIS). Plasma concentration of dexmedetomidine and propofol.;Timepoint(s) of evaluation of this end point: When the second breathing test is done and the acute hypercapnic ventilatory response has been measured during infusion of dexmedetomidine to achieve a moderate level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S).	—

Measure

Time frame

Secondary end point(s): Hypercapnic ventilatory respons. Respiratory rate. Tidal volume. Airway flow. Thoracic and abdominal impedance. Oxygen saturation. Level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S), Richmond Agitation Sedation Score (RASS) and bispectral index (BIS). Plasma concentration of dexmedetomidine and propofol.;Timepoint(s) of evaluation of this end point: When the second breathing test is done and the acute hypercapnic ventilatory response has been measured during infusion of dexmedetomidine to achieve a moderate level of sedation according to Observer´s Assessment of Alertness/Sedation Scale (OAA/S).

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Countries

Sweden

Contacts

Public ContactClinical Research Unit

Karolinska University Hospital

460851772066

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026