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Completed

NCT Number: NCT05340335

ED90 of Remimazolam Loading Dose for Sedation in Patients Under Monitored Anesthetic Care

Currently used drugs for monitored general anesthesia include propofol, midazolam, and dexmedetomidine. Each drug has different advantages and disadvantages. Remimazolam causes a relatively small decrease in blood pressure, and it has no injection pain. In addition, remimazolam has a very short onset time, and even after the continuous infusion, the onset of remimazolam is fast, and even after continuous injection, the effect disappeared very quickly due to the short context-sensitive half time. nd through continuous infusion, the patient's depth of anesthesia can be maintained constant. In addition, the short duration of action and the ability to quickly reverse the effect of flumazenil suggest that remimazolam can be used effectively under general anesthesia as well as under general anesthesia. Remimazolam can be used as a continuous infusion for general anesthesia. However, it has also been reported to be used for sedation by continuous infusion or divided intravenous infusion. However, the effective infusion dose of remimazolam for supervised general anesthesia without mechanical ventilation has not been established.

In this study, the ED90 of the loading dose to induce loss of consciousness in patients when supervised general anesthesia is performed through continuous infusion of Remimazolam is to be obtained.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA PS 1-3
  • Patients who are scheduled to undergo upper/lower limb surgery under the monitored anesthetic care with remimazolam

Exclusion criteria

  • Patients who refuse to participate in this study
  • Patients with hypersensitivity to benzodiazepine or flumazenil
  • Patients with severe renal/hepatic disease
  • Patients with drug/alcohol abuse
  • Patients who take antidepressants, anticonvulsants, psychoactive drugs chronically
  • Patients with difficulty in communication
  • Patients with severe obstructive sleep apnea or other airway problems
  • Patients contraindicated to regional anesthesia
  • Patients judged to be inappropriate for this study

Treatment and study plan

Remimazolam

Drug

A beginning dose of remimazolam is 1mg/kg/hr. When sedation is not achieved in 10 minutes, the dose will be increased by 0.1mg/kg/hr in the next patient. When sedation is successful, the same dose will be used with the probability of 0.89, or the dose will be decreased by 0.1mg/kg/hr with the probability of 0.11 in the next patient. (maximal dose: 2mg/kg/hr)

Primary outcomes

  1. Whether sedation was successful

    Time frame: for 10 minutes from the initiation of the remimazolam administration

    MOAA/S score of 3 or less (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)

Secondary outcomes

  1. Total amount of remimazolam for sedation

    Time frame: From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes

    MOAA/S score of 3 or less

  2. Effect site concentration

    Time frame: From the initiation of the remimazolam administration to the time when MOAA/S score of 3 or less, assessed up to 10 minutes

    Calculated by a computerized program(Asanpump)

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Determination of the Effective Dose 90 of Remimazolam Loading Dose for Adequate Sedation in Patients Undergoing Orthopaedic Surgery Under Monitored Anesthetic Care

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Jul 21, 2022

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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