Study of Respiratory Depression During Analgosedation Technique Combining Remifentanyl and Ketamine in TCI for Oocyte Retrieval
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- respiratory depression
研究概览
简要总结
This study evaluates the effect of the addition of ketamine to a conscious sedation protocol including remifentanil during oocyte retrieval. The investigators will have 2 groups with different target effect site concentrations, namely 150 ng/ml and 200 ng/ml.
详细描述
The actual protocol for conscious sedation during oocyte retrieval in at the Erasmus hospital (Brussels) consists of Remifentanil in TCI-mode, with premedication by Midazolam. However, episodes of bradypnaea with or without desaturation are still common.
The primary objective is to observe if with the addition of ketamine, it is possible to significantly reduce the dose of Remifentanil, in order to avoid episodes of respiratory depression caused by the opioid.
The secondary outcomes measured, will be the pain levels experienced by the patient, the sedation level, and the satisfaction of the patients after the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •patients having an oocyte retrieval
排除标准
- •BMI > 30
- •endometriosis
- •contraindications to ketamine
研究组 & 干预措施
ketamine 150 ng/ml
The first group will receive the classical premedication with 2 mg of Midazolam. A bolus dose of Ketamine will be given, then to be titrated in TCI mode with a target concentration of 150 ng/ml. Right after, the Remifentanil TCI will be started at a concentration of 1 ng/ml and the procedure can begin.
干预措施: Ketamine 150 ng/ml (Drug)
ketamine 150 ng/ml
The first group will receive the classical premedication with 2 mg of Midazolam. A bolus dose of Ketamine will be given, then to be titrated in TCI mode with a target concentration of 150 ng/ml. Right after, the Remifentanil TCI will be started at a concentration of 1 ng/ml and the procedure can begin.
干预措施: Remifentanil (Drug)
ketamine 150 ng/ml
The first group will receive the classical premedication with 2 mg of Midazolam. A bolus dose of Ketamine will be given, then to be titrated in TCI mode with a target concentration of 150 ng/ml. Right after, the Remifentanil TCI will be started at a concentration of 1 ng/ml and the procedure can begin.
干预措施: Oocyte retrieval (Procedure)
ketamine 200 ng/ml
The second group will be treated in the exact way as the first, with the exception that the target effect site concentration is aimed at 200 ng/ml.
干预措施: Remifentanil (Drug)
ketamine 200 ng/ml
The second group will be treated in the exact way as the first, with the exception that the target effect site concentration is aimed at 200 ng/ml.
干预措施: Oocyte retrieval (Procedure)
ketamine 200 ng/ml
The second group will be treated in the exact way as the first, with the exception that the target effect site concentration is aimed at 200 ng/ml.
干预措施: Ketamine 200 ng/ml (Drug)
结局指标
主要结局
respiratory depression
时间窗: through study completion, an average of 2 months
respiratory rate (number of inspiration per minute)
Respiratory depression
时间窗: through study completion, an average of 2 months
SpO2 (%)
次要结局
- pain(through study completion, an average of 2 months)
- Sedation level(through study completion, an average of 2 months)
- patient satisfaction(through study completion, an average of 2 months)
- sedation level(through study completion, an average of 2 months)
- Pain(through study completion, an average of 2 months)
- pregnancy rate(15 days after the oocyte retrieval)
- ketamine dosage(through study completion, an average of 2 months)
- Arterial pressure(through study completion, an average of 2 months)
- Heart rate(through study completion, an average of 2 months)
研究者
Luc Barvais
MD PhD
Erasme University Hospital