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Research Article
Song Lyu
Second Affiliated Hospital of Hainan Medical University
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
This study was conducted to determine how remimazolam and propofol interact when given with sufentanil.
Methods
In this single-arm study, patients were assigned to one of five groups. The sample size was not determined in advance. When the median effective dose(ED50) and 95% confidence intervals were calculated, participants were stopped. The study included 159 patients who were scheduled for a gastrointestinal endoscopic examination and had an American Society of Anesthesiologists physical status of I/II. Patients were intravenously administered sufentanil (0.1 µg/kg), along with different doses of remimazolam and propofol depending on the group to which they were assigned. The endpoint for an effective response was the disappearance of the bilateral eyelash reflex. The up-and-down method was used to determine the ED50 within each treatment group. The ED50 deviations from the additive line were analyzed using isoradiometric analysis. The interaction coefficients were calculated by algebraic analysis. Interval estimation is used in statistical inference.
Results
In combination with sufentanil, the ED50 of remimazolam and propofol was determined to be 0.065 (0.057-0.074) mg/kg and 0.657 (0.590-0.724) mg/kg, respectively. After sufentanil administered, when 0.25, 0.5, and 0.75 ED50 remimazolam were given in combination with propofol, the interaction coefficients were 1.03,1.2and 1.08, respectively.
Conclusions
The dose of propofol with remimazolam may need to be reduced regardless of the additive or synergistic effect. There was a strong synergistic effect when the dose ratio of the two drugs was about 6:1 in mg/kg.
Trial registration:
The project was retrospectively registered on October 26, 2021 in Chinese clinical trial center with the registration number of ChiCTR2100052425.
Keywords
Drug synergism, Gastroscopy, Propofol, Remimazolam, Sufentanil
Figure 1
Figure 2
No competing interests reported.
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This preprint is under consideration at BMC Anesthesiology. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Song Lyu
Second Affiliated Hospital of Hainan Medical University
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 08 Nov, 2021
No community comments so far
Editor invited
On 02 Nov, 2021
Submission checks complete
On 02 Nov, 2021
First submitted
On 31 Oct, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Anesthesiology & Pain Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background
This study was conducted to determine how remimazolam and propofol interact when given with sufentanil.
Methods
In this single-arm study, patients were assigned to one of five groups. The sample size was not determined in advance. When the median effective dose(ED50) and 95% confidence intervals were calculated, participants were stopped. The study included 159 patients who were scheduled for a gastrointestinal endoscopic examination and had an American Society of Anesthesiologists physical status of I/II. Patients were intravenously administered sufentanil (0.1 µg/kg), along with different doses of remimazolam and propofol depending on the group to which they were assigned. The endpoint for an effective response was the disappearance of the bilateral eyelash reflex. The up-and-down method was used to determine the ED50 within each treatment group. The ED50 deviations from the additive line were analyzed using isoradiometric analysis. The interaction coefficients were calculated by algebraic analysis. Interval estimation is used in statistical inference.
Results
In combination with sufentanil, the ED50 of remimazolam and propofol was determined to be 0.065 (0.057-0.074) mg/kg and 0.657 (0.590-0.724) mg/kg, respectively. After sufentanil administered, when 0.25, 0.5, and 0.75 ED50 remimazolam were given in combination with propofol, the interaction coefficients were 1.03,1.2and 1.08, respectively.
Conclusions
The dose of propofol with remimazolam may need to be reduced regardless of the additive or synergistic effect. There was a strong synergistic effect when the dose ratio of the two drugs was about 6:1 in mg/kg.
Trial registration:
The project was retrospectively registered on October 26, 2021 in Chinese clinical trial center with the registration number of ChiCTR2100052425.
Figure 1
Figure 2
No competing interests reported.
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