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测定肥胖或非肥胖儿童和青少年单次推注右美托咪定达到充分镇静所需的 ED。

Determination of the ED of a single bolus dose of dexmedetomidine for adequate sedation in obese or nonobese children and adolescents.

机构信息

Department of Anaesthesiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.

Department of Anaesthesiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.

出版信息

Br J Anaesth. 2021 Mar;126(3):684-691. doi: 10.1016/j.bja.2020.11.037. Epub 2021 Jan 23.

DOI:10.1016/j.bja.2020.11.037
PMID:33495020
Abstract

BACKGROUND

With the increasing prevalence of children who are overweight and with obesity, anaesthesiologists must determine the optimal dosing of medications given the altered pharmacokinetics and pharmacodynamics in this population. We therefore determined the single dose of dexmedetomidine that provided sufficient sedation in 95% (ED) of children with and without obesity as measured by a minimum Ramsay sedation score (RSS) of 4.

METHODS

Forty children with obesity (BMI >95th percentile for age and gender) and 40 children with normal weight (BMI 25th-84th percentile), aged 3-17 yr, ASA physical status 1-2, undergoing elective surgery, were recruited. The biased coin design was used to determine the target dose. Positive responses were defined as achievement of adequate sedation (RSS ≥4). The initial dose for both groups was dexmedetomidine 0.3 μg kg i.v. infusion for 10 min. An increment or decrement of 0.1 μg kg was used depending on the responses. Isotonic regression and bootstrapping methods were used to determine the ED and 95% confidence intervals (CIs), respectively.

RESULTS

The ED of dexmedetomidine for adequate sedation in children with obesity was 0.75 μg kg with 95% CI of 0.638-0.780 μg kg, overlapping the CI of the ED estimate of 0.74 μg kg (95% CI: 0.598-0.779 μg kg) for their normal-weight peers.

CONCLUSIONS

The ED values of dexmedetomidine administered over 10 min were 0.75 and 0.74 μg kg in paediatric subjects with and without obesity, respectively, based on total body weight.

CLINICAL TRIAL REGISTRATION

ChiCTR1800014266.

摘要

背景

随着超重和肥胖儿童的日益增多,麻醉师必须根据该人群中改变的药代动力学和药效学来确定药物的最佳剂量。因此,我们确定了右美托咪定的单次剂量,该剂量可使 95%(ED)的肥胖和非肥胖儿童达到足够的镇静效果,最低 Ramsay 镇静评分(RSS)为 4。

方法

招募了 40 名肥胖儿童(BMI 大于年龄和性别第 95 百分位的肥胖儿童)和 40 名正常体重儿童(BMI 为 25 百分位至 84 百分位),年龄 3-17 岁,ASA 身体状况 1-2 级,接受择期手术。使用偏倚硬币设计确定目标剂量。阳性反应定义为达到足够的镇静(RSS≥4)。两组的初始剂量均为右美托咪定 0.3μg/kg 静脉输注 10 分钟。根据反应增加或减少 0.1μg/kg。使用等比回归和自举法分别确定 ED 和 95%置信区间(CI)。

结果

肥胖儿童达到足够镇静的右美托咪定 ED 为 0.75μg/kg,95%CI 为 0.638-0.780μg/kg,与正常体重儿童的 ED 估计值 0.74μg/kg(95%CI:0.598-0.779μg/kg)的 CI 重叠。

结论

根据总体重,肥胖和非肥胖儿科患者接受右美托咪定 10 分钟静脉输注的 ED 值分别为 0.75 和 0.74μg/kg。

临床试验注册

ChiCTR1800014266。

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