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Relationship Between Remimazolam and Etomidate in Induction of General Anesthesia

ConditionsInduction AnesthesiaDrug Interactions
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSecond Hospital of Shanxi Medical University

About this trial

In modern anesthesia practice, anesthesiologists often need to choose a combination of multiple drugs according to the specific conditions and surgical needs of patients, which can not only achieve more fine anesthesia management, but also improve perioperative safety and patient comfort. In clinical practice, anesthesiologists will use etomidate combined with a small dose of remimazolam for anesthesia induction to obtain more stable hemodynamics, prevent intraoperative awareness, and relieve anxiety.However, what is the best dose ratio of etomidate combined with remimazolam, the current literature does not give clear indicators.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Both sexes

aged 18-60 yr

ASA physical status I-II

BIM: 18-28kg/m²

Disqualifiers

allergic to remimazolam and etomidate

in pregnancy or lactation

serious cardiovascular diseases, long-term alcoholism

used sedative drugs or opioids within 24 hours

Trial design

Design model

Sequential

Treatments tested in this trial

  • Etomidate

    Drug

    Group A was induced with etomidate, the initial dose was 0.120mg/kg, and the ratio of adjacent doses was 1:0.6

  • Remimazolam

    Drug

    Group B was induced with remimazolam, the initial dose was 0.20mg/kg, and the ratio of adjacent doses was 1:0.8

  • Remimazolam-etomidate

    Drug

    In group C, 0.25ED50 remimazolam +0.75ED50 etomidate was used as the initial measurement In group D, 0.5ED50 remimazolam +0.5ED50 etomidate was used as the initial measurement In group E, 0.75ED50 of remimazolam +0.25ED50 of etomidate was used as the initial measurement

Treatment groups

125 Participants
are divided into 5 treatment groups
Group A: Group A (remimazolam induction group)Experimental treatment 1 intervention
Group B: Group B (etomidate induction group)Experimental treatment 1 intervention
Group C: group C (0.25ED50 remimazolam +0.75ED50 etomidate)Experimental treatment 1 intervention
Group D: Group D (0.5ED50 remimazolam +0.5ED50 etomidate)Experimental treatment 1 intervention
Group E: Group E (0.75ED50 remimazolam +0.25 etomidate)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The ED50 value of etomidate in Group A

The sequential method was used to calculate the median effective dose of etomidate in group A. When the patient's BIS value was between 45 and 60, it was considered a positive response. For the next patient, the dose was reduced by one dose gradient; conversely, if it was a negative response, the dose was increased by one dose gradient. The observation was stopped when the first patient reached the positive-negative turning point, and the next patient with the positive-negative reaction was reached for the seventh turning point. The ED50 of each group was calculated using the probit model.

Time frame
one week
2

The ED50 value of Remimazolam in Group B

The sequential method was used to calculate the median effective dose of remimazolam in group B. A positive reaction was defined as a patient's BIS value ranging from 45 to 60. For the next patient, the dose was reduced by one dose gradient if it was a positive reaction, and increased by one dose gradient if it was a negative reaction. The observation was stopped when the next patient with the 7th positive-negative reaction point was reached. The ED50 of each group was calculated using the probit model.

Time frame
one week
3

Group C D E: etomidate ED50

The sequential method was adopted to calculate the median effective dose of etomidate for groups C, D, and E separately. A patient was considered to have a positive response if their BIS value was between 45 and 60. For the next patient, the dose was reduced by one dose gradient if it was a positive response, and increased by one dose gradient if it was a negative response. The observation was ended when the next patient with the 7th positive-negative response was reached. The ED50 of each group was calculated using the probit model.

Time frame
three weeks
4

Isoradiation pattern

The ED50 determined for groups A and B was plotted on the isoradiogram. The ED50 of etomidate and its 95% confidence interval were plotted on the horizontal axis, and the ED50 of remimazolam and its 95% confidence interval were plotted on the vertical axis. The two ED50 were connected to form an additive line, and the confidence interval was connected to form an additive line with 95% confidence interval. When the two drugs were used together, the effect intensity of the compound drugs fell on the additive line (or within the confidence interval), indicating that the two drugs had additive effect. On the left side of the addition line and confidence interval, it indicated that the two drugs had synergistic effect. If it falls on the right side, it is antagonistic.

Time frame
24 hours

Secondary outcomes

1

muscle tremor

Side effects of etomidate

Time frame
5 weeks
2

Bradycardia

The heart rate was less than 45 beats per minute

Time frame
5 weeks
3

hypotension

Blood pressure is lower than the baseline by 20%.

Time frame
5 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Hospital of Shanxi Medical University

Lead sponsor

Source ClinicalTrials.gov

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