Not Yet RecruitingPhase 4ACTRN12623000133639

Continuous infusion of remimazolam for intraoperative sedation as a safe and effective option: a prospective clinical study.


Sponsor

Antonia Kustura, MD

Enrollment

50 participants

Start Date

Feb 20, 2023

Study Type

Interventional

Conditions

Summary

The purpose of the research is to determine the necessary range of continuous doses of remimazole for procedural sedation or sedation with regional anesthesia as an alternative to other, less hemodynamically and respiratory safe drugs that are currently used, propofol and midazolam. Research hypothesis: A continuous dose of remimazolam adjusted for the body weight and height of the patient is a sufficient and hemodynamically and respiratory safe alternative to currently used drugs in doses comparable to bolus doses.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria1

  • Adult patients between 18 and 80 years of age, ASA class I, II and III, scheduled for elective procedural sedation or sedation with regional anaesthesia.

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Interventions

Drug: remimazolam For patients undergoing elective procedural sedation or sedation with regional anaesthesia. Anticipated duration of the procedure is up to one hour. Bispectral Index (BIS) monitori

Drug: remimazolam For patients undergoing elective procedural sedation or sedation with regional anaesthesia. Anticipated duration of the procedure is up to one hour. Bispectral Index (BIS) monitoring using sensors which are placed on the forehead of participants is used to measure the participant's level of consciousness and with that to monitor the depth of anaesthesia. The examiner will use Modified Observer's Alertness/Sedation scale (MOAA/S) and Richmond Agitation-Sedation Scale (RASS) values to measure the agitation or sedation level of a participants. The examiner will measure MOAA/S and RASS values at the beginning of the procedure. Remimazolam will be started with the loading dose of 5mg intravenously over a 1-minute time period. After the loading dose, the continuous intravenous infusion of remimazolam will start, which will be titrated to maintain the target Bispectral Index (BIS) values of 60-80 during procedure, which indicates an adequate depth of sedation. During the entire procedure, BIS, MOAA/S and RASS values will be measured and recorded at 5-minute intervals, and depending on the obtained values, the remimazolam infusion rate will be corrected. At the end of the procedure, after stopping the administration of the drug, the time required from the end of the infusion to the complete recovery of consciousness will be measured.


Locations(1)

City of Zagreb, Croatia

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ACTRN12623000133639