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临床试验/NCT04397393
NCT04397393终止不适用

Does Camel Milk Consumption Decrease The Efficacy Of Midazolam For Sedation: A Pilot Study

ART Fertility Clinics LLC1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
26
试验地点
1
主要终点
Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform the OPU

研究概览

简要总结

The primary aim is to verify if camel milk consumption has an impact on the amount of Midazolam needed to achieve a satisfactory level of sedation for oocyte retrieval, compared to patients never having consumed camel milk.

详细描述

A pilot study will be performed on patients undergoing oocyte retrieval (OPU) for the first time, and correlated to camel milk consumption versus never consumed camel milk, as well as age, BMI (body mass index), number of follicles at the time of OPU, number of previous OPUs in other clinics, previous vaginal delivery, past medical history positive for chemo therapy, alcohol consumption, use of prescribed or illicit drugs, or chronic pain medication.

The main objective is to analyse if the consumption of camel milk, the frequency, or lack thereof correlates with the amount of the sedative drug Midazolam needed to achieve an acceptable level of sedation in order to estimate the dosage needed in both patient groups more adequately, reducing either discomfort felt at a too low an initial dosage, as well as avoiding a deeper level of sedation than needed with subsequent prolonged stay in recovery and unpleasant feelings of dizziness and drowsiness, potentially requiring antagonizing Midazolam by the use of Flumazenil, and reducing overall costs and length of stay in recovery and bed occupancy and enhancing patient experience and satisfaction.

Would this study enable the Investigators to determine further effect of camel milk on other drugs used for various other purposes, and lead to a change in dose regimen?

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Arab origin
  • Female 18 -48 years of age
  • BMI < 37 kg/m2
  • All ovarian stimulation protocols

排除标准

  • Previous oocyte retrieval at our center
  • Post chemo therapy
  • Illicit drug use
  • Chronic pain medication
  • Medication which is known to increase the activity of liver enzymes
  • Any alcohol consumption
  • Previous vaginal delivery

研究组 & 干预措施

non-camel milk consumption

non-camel milk consumption over life time

干预措施: Midazolam (Drug)

camel milk consumption

camel milk consumption at least once during lifetime, with 2 subgroups of camel milk consumption: once, twice, three times; as well as regularly (daily, once per week, once per month, once per year).

干预措施: Midazolam (Drug)

结局指标

主要结局

Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform the OPU

时间窗: 1 day

Mean dosage of Midazolam for both groups (Camel milk consumption vs no camel milk consumption

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nils Engelmann

Anesthesia Consultant

ART Fertility Clinics LLC

研究点 (1)

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