Evaluation of the efficacy and safety of remazolam in tooth extraction surgery: A randomized,single-blind,multi-center clinical trial

Abstract

BACKGROUND:

Dental extraction or tooth extraction is a common clinical radical treatment surgery.

OBJECTIVE:

To explore the efficacy and safety of remimazolam in tooth extraction surgery in a randomized, single-blind, multi-center clinical trial.

METHOD:

Patients who underwent tooth extraction surgery at Jinan Stomatological Hospital from April 2022 to March 2023 were selected as the research subjects, and they were divided into a control group and an observation group using the random arrangement table method. The patients in the control group were anesthetized with midazolam, and the patients in the observation group were anesthetized with remimazolam. Collect the general demographic data of the patients, use the propensity score matching method (PSM) to balance the baseline data of the two groups, and use $t$ -test, chi-square test, and analysis of variance to compare the hemodynamics, anesthesia maintenance period indicators, and alertness/Sedation scores and occurrence of adverse reactions.

RESULT:

PSM matching was performed according to a 1:1 ratio, and 40 patients were included in the observation and control groups. There was no statistical significance in the baseline data of the two groups. Compared with T₀, the hemodynamic indexes of both groups of patients increased at T₁, T₂, T₃, T₄, and T₅ ( $P<$ 0.05), but the indexes at T₀ and T₂ were the same. The same ( $P>$ 0.05), and the indicators of the observation group at T₁, T₃, T₄, and T₅ were higher than those of the control group ( $P<$ 0.05); the administration time of the two groups of patients was the same ( $P>$ 0.05), but the observation group The recovery time and onset of effect were shorter than those in the control group ( $P<$ 0.05); at T₀, the clinical behavior scores of the two groups of patients were the same ( $P>$ 0.05), and at T₁, the scores of the observation group were lower than those of the control group ( $P<$ 0.05); at T₀ and T₁, the alertness/sedation scores of the patients in the observation group were lower than those in the control group, but at T₂, the scores of the patients in the observation group were higher than those in the control group ( $P<$ 0.05); the total clinical adverse reactions of the patients in the observation group were The incidence rate (5.00%) was lower than that of the control group (30.00%) ( $P<$ 0.05).

CONCLUSION:

The use of remimazolam during tooth extraction can stabilize the patient’s hemodynamics, shorten the recovery and onset time, stabilize the patient’s behavior, have an excellent soothing effect, have fewer adverse reactions, and be safer, so it is worthy of use.