Effects of S-ketamine on Perioperative Opioid Consumption in a Standardized Analgesia Administration Strategy. A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- postoperative opioid consumption
研究概览
简要总结
This study is a triple-blind randomized controlled trial conducted at a tertiary care hospital in Brussels. It investigates whether a single dose of S-ketamine can reduce opioid (morphine) consumption in the first 24 hours after elective laparoscopic gynecological surgery in relatively healthy adult patients (ASA 1-2). The goal is to assess S-ketamine's effectiveness within a standardized postoperative pain management protocol.
详细描述
This research focuses on improving postoperative pain management by evaluating the potential opioid-sparing effect of S-ketamine. While S-ketamine is known for its analgesic properties, its impact when used as a single dose alongside standardized analgesia protocols had not been previously studied in this specific surgical setting.
To address this, the investigators designed a triple-blind randomized controlled trial, meaning that the patients, healthcare providers, and outcome assessors were all unaware of treatment allocation. This design minimizes bias and strengthens the reliability of the findings.
The study was conducted at a tertiary care academic hospital in Brussels (Erasme Hospital), ensuring a controlled clinical environment with standardized procedures.
A total of 53 adult patients were included. All participants were classified as ASA physical status 1 or 2, indicating they were either healthy or had only mild systemic disease. These patients were scheduled for elective laparoscopic gynecological surgery, a procedure typically associated with moderate postoperative pain.
The primary objective of the study was to evaluate whether administering a single dose of S-ketamine could reduce postoperative opioid consumption, specifically measured as the total amount of morphine used during the first 24 hours after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult patients American Society of Anesthesiologists (ASA) physical status classification I or II
- •Scheduled for elective laparoscopic gynecological surgery
排除标准
- •Body mass index (BMI) > 30 kg/m²
- •Known allergy to any drugs used in the study
- •Chronic pain patients or regular use of analgesics
- •Pregnant or breastfeeding patients
研究组 & 干预措施
Stdudy group
Once the intravenous line was secured, the study syringe was connected, and the contents (0.3 mg · kg-1 S-ketamine diluted in 50 ml of saline) were administered intravenously for one hour.
干预措施: Saline (0.9% NaCl) (Drug)
control group
Once the intravenous line was secured, the study syringe was connected, and the content (50 ml of saline) was administered intravenously for one hour.
干预措施: Saline (0.9% NaCl) (Drug)
Stdudy group
Once the intravenous line was secured, the study syringe was connected, and the contents (0.3 mg · kg-1 S-ketamine diluted in 50 ml of saline) were administered intravenously for one hour.
干预措施: Esketamine at low dose (Drug)
结局指标
主要结局
postoperative opioid consumption
时间窗: from the end of the surgery up to 24 hours after surgery
The primary outcome was postoperative opioid consumption, defined as morphine consumption in the first 24 hours after surgery
次要结局
- perioperative opioid consumption(from the induction of anesthesia until the end of the surgery)
- perioperative hypnotic consumption(from the induction of anesthesia until the end of the surgery)
- time of emergence from anesthesia(From cessation of anesthetic drug infusion until extubation, assessed at the end of surgery)
研究者
Ionut Tabolcea, MD
Principal Investigator
Erasme University Hospital