Comparison of Analgesic Effect and Prognosis of Butorphanol and Fentanyl in Patients With Mechanical Ventilation

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

ICU patients often in a strong stress environment. Various invasive procedures such as wound dressing change, sputum suction,Pull out the thoracic duct etc. At the same time, the diseases and environmental factors caused patients anxiety, pain, delirium and even a series of pathophysiological changes which harm life and safety. Fentanyl is an analgesic that acts on central μ receptors, clinical practice had found that fentanyl could exert analgesic effects, while it maybe affect patients' hemodynamics, breathing, and nervous system, which caused hypotension, bradycardia, respiratory depression, delirium and other adverse drug reactions. These reactions prolonged the mechanical ventilation time and duration time of patients in hospital, which impact the treatment effect and prognosis of patients. Butorphanol tartrate is a new type of opioid receptor agonist and antagonist, which can stimulate the κ receptor, and also certain stimulated and antagonised effects on the μ receptor. It can be used for analgesia and sedation in patients of ICU. Previous studies shown that butorphanol can inhibit the inflammatory response and effect myocardial protective. The analgesic effect of butorphanol were equivalent to fentanyl in patients of ICU, and the incidence of nausea and vomiting in participants with butorphanol less than fentanyl. Therefore, the investigators speculate that the analgesia of butorphanol in ICU patients may unexpected effects. However, butorphanol and fentanyl on the analgesic effect and prognosis of patients with mechanical ventilation in ICU are lacking currently, and the investigators no corresponding multi-center clinical study at home and abroad. The research compare to the analgesic effect of butorphanol and fentanyl in critically ill patients with mechanical ventilation. Effects of butorphanol and fentanyl on mechanical ventilation duration, sedation depth, duration time of patients in hospital, complications and mortality in patients with mechanical ventilation. To analyze the high-risk factors affecting the prognosis of patients with mechanical ventilation in ICU. Found more treatment measures for analgesia of patients with mechanical ventilation in ICU.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Hengrui Pharmaceutical Co., Ltd.
• Treatments: Analgesics; Butorphanol; Fentanyl; Propofol

Criteria

Inclusion Criteria:

1. aged >= 18 years, 18kg / m2 < BMI < 30 kg / m2;

2. patients with invasive mechanical ventilation (refer to the clinical application guide of mechanical ventilation [2006];

3. the expected ventilation time was >= 24h, and the ventilation time was < 48h;

4. sign the informed consent voluntarily and participate in the research. -

Exclusion Criteria:

1. known allergy to any study drug;

2. for chronic pain of grade 3 or above in the World Health Organization, strong opioids, such as morphine, are often used. Recently, opioids are used for analgesia through spinal cord catheter, epidural or any other regional block;

3. the American Society of anesthesiologists (ASA) classified the fifth grade patients (on the verge of death);

4. nerve injury or brain organic pathological changes;

5. participate in clinical research in the past 30 days;

6. pregnancy or lactation;

7. the researcher thinks it is not suitable to participate in the clinical trial.