2026-526531-18-00招募中4 期
Perioperative Intravenous Metamizole in Laparoscopic Cholecystectomy: A rondomized, double blind, clinical trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Leuven
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- The primary endpoint is the opioid consumption in IV morphine milligram equivalents (MME) administered peroperatively and during the first 3 postoperative hours.
研究概览
简要总结
To determine whether the addition of intraoperative metamizole 1 g IV to a standard multimodal analgesic regimen (paracetamol and ibuprofen) reduces opioid consumption (IV MME), administered peroperatively and during the first three postoperative hours, compared with placebo, in patients undergoing elective laparoscopic cholecystectomy
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow-up
- 盲法
- Double (Investigator, Carer, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
- •Suitable for outpatient surgery (ASA 1-2 or 3).
- •Between 18 and 75 years of age
- •Elective Laparoscopic cholecystectomie in a day-surgery center
- •Dutch speaking
- •≥53 kg body weight
排除标准
- •Participant has a history of Allergy or Intolerance for medication used in general anesthesia.
- •History of hypersensitivity to pyrazolones/pyrazolidines or of analgesic-induced bronchospasm/anaphylactoid reaction (e.g. to salicylates, paracetamol, diclofenac, ibuprofen, indometacin or naproxen).
- •Acute intermittent hepatic porphyria
- •Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Pre-operative hypotension or haemodynamically unstable status
- •Participant has a history of Allergy or Intolerance for the IMP.
- •Participant has a history of chemotherapy within 2 years prior to screening.
- •History or active agranulocytosis or other hematological disorders.
- •History of or active gastric/duodenal ulceration or bleeding.
- •Use of chronic pain medication (including opioids, antidepressants, Long-term use of NSAIDs,…).
- •Body mass index (BMI) >35 kg/m².
- •Any other condition or state that, in the opinion of the investigator, may affect the patient’s safety or the integrity of the study.
- •If applicable: Female who is pregnant, breastfeeding, or intends to become pregnant, or is of childbearing potential and not using an adequate, highly effective contraceptive. Women of child bearing potential (WOCBP) should only be included after a confirmed menstrual period and urinary pregnancy test. Participants are considered not of childbearing potential if they are surgically sterile (i.e., they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal, defined as no menses for 12 months without an alternative medical cause.
研究组 & 干预措施
NOVALGINE I.M./I.V. 1000 mg/2 ml solution injectable
Test
干预措施: NOVALGINE I.M./I.V. 1000 mg/2 ml solution injectable (Drug)
MINI-PLASCO NACL B. BRAUN 0,9 %, oplossing voor injectie
Placebo
干预措施: MINI-PLASCO NACL B. BRAUN 0,9 %, oplossing voor injectie (Drug)
结局指标
主要结局
The primary endpoint is the opioid consumption in IV morphine milligram equivalents (MME) administered peroperatively and during the first 3 postoperative hours.
The primary endpoint is the opioid consumption in IV morphine milligram equivalents (MME) administered peroperatively and during the first 3 postoperative hours.
次要结局
- Aldrete score (evaluated every 15, during PACU stay)
- PADSS (every hour from admission to Day Care Unit until discharge from hospital)
- Time to be ready for discharge from hospital Day Care Unit
- Opioid consumption until discharge (IV morphine equivalents)
- Number of given doses of rescue analgesia on PACU
- Mean NRS hourly after PACU stay until discharge
- Time to first rescue analgesia in PACU
- Analgesic consumption (0-48h postoperative)
- QoR-15 POD1 and POD2
- Mean NRS (evaluated every 15 minutes until 60’ postoperative (+0’ +15’, +30’, +45’, +60’))
研究者
An Teunkens
Scientific
UZ Leuven
研究点 (2)
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