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Completed

NCT Number: NCT04901871

Remimazolam Bolus for General Anesthesia

It is important to estimate the adequate dose of remimazolam intravenous bolus injection to induce the loss of consciousness. We will determine the ED50 and ED95 of remimazolam intravenous bolus on the loss of consciousness in patients undergoing general anesthesia.

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Key information

Conditions

Loss of Consciousness Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gangnam Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for general anesthesia

Exclusion criteria

  • Patients scheduled for liver surgery
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Liver disease
  • Kidney disease
  • Intolerance or hypersensitivity to benzodiazepine
  • Addiction
  • Glaucoma
  • Heart failure
  • Peripheral vascular disease
  • Obstuctive lung disease
  • Patients scheduled for regional anesthesia before general anesthesia
  • Pregnancy

Treatment and study plan

0.02 mg/kg, age<65

Drug

Remimazolam of 0.02 mg/kg will be infused in patients aged<65.

0.07 mg/kg, age<65

Drug

Remimazolam of 0.07 mg/kg will be infused in patients aged<65.

0.12 mg/kg, age<65

Drug

Remimazolam of 0.12 mg/kg will be infused in patients aged<65.

0.17 mg/kg, age<65

Drug

Remimazolam of 0.17 mg/kg will be infused in patients aged<65.

0.22 mg/kg, age<65

Drug

Remimazolam of 0.22 mg/kg will be infused in patients aged<65.

0.27 mg/kg, age<65

Drug

Remimazolam of 0.27 mg/kg will be infused in patients aged<65.

0.02 mg/kg, age≥65

Drug

Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.

0.07 mg/kg, age≥65

Drug

Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.

0.12 mg/kg, age≥65

Drug

Remimazolam of 0.12 mg/kg will be infused in patients aged≥65

0.17 mg/kg, age≥65

Drug

Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.

0.22 mg/kg, age≥65

Drug

Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.

0.27 mg/kg, age≥65

Drug

Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.

Primary outcomes

  1. Loss of consciousness within 5 minutes

    Time frame: At 5 minutes after infusion

    Loss of consciousness will be evaluated at 5 minutes after infusion.

Secondary outcomes

  1. Time to loss of consciousness

    Time frame: At 5 minutes after infusion (time to loss of consciousness)

    Time to loss of consciousness will be assessed at 5 minutes after infusion.

  2. blood pressure

    Time frame: At 5 minutes after infusion

    Blood pressure will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.

  3. heart rate

    Time frame: At 5 minutes after infusion

    Heart rate will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.

  4. sedline

    Time frame: At 5 minutes after infusion

    Sedline will be measured at 0, 1, 2, 3, 4, 5 minutes after infusion.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

ED50 and ED95 of Remimazolam Intravenous Bolus on the Loss of Consciousness in Patients Undergoing General Anesthesia

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 26, 2021
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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