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

NCT04315935 | Unknown Phase 4

• 1 other identifier: SINGCHN-BUT-IV-1902
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (3)

• Analgesic score,

  Analgesia score (CPOT \< 3 points)

  Maintain target analgesia score (CPOT<3) from 100% time to 80% time

• sedative score

  APACHE II score, SOFA score,

  Maintain target analgesia score (CPOT<3) from 100% time to 80% time

• Total dosage of butorphanol， fentanyl，propofol;

  The specific dosage of butorphanol, fentanyl and propofol,

  Maintain target analgesia score (CPOT<3) from 100% time to 80% time

Secondary Outcomes (1)

• Major indicators affecting the prognosis of patients in ICU

  From day 1 to day 30

Other Outcomes (1)

• Incidence of adverse reactions

  From day 1 to day 30

Study Arms (2)

butorphanol group

EXPERIMENTAL

Butorphanol (10-20 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation

Drug: Butorphanol and Propofol

fentanyl group

ACTIVE COMPARATOR

Fentanyl (0.7-10 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation

Drug: Fentanyl and Propofol

Interventions

Butorphanol and Propofol DRUG

The two groups were given propofol for sedation, BG for butorphanol for analgesia and FG for fentanyl for analgesia

butorphanol group

Fentanyl and Propofol DRUG

Fentanyl (0.7-10 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation

fentanyl group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged \>= 18 years, 18kg / m2 \< BMI \< 30 kg / m2;
• patients with invasive mechanical ventilation (refer to the clinical application guide of mechanical ventilation \[2006\];
• the expected ventilation time was \>= 24h, and the ventilation time was \< 48h;
• sign the informed consent voluntarily and participate in the research. -

You may not qualify if:

• known allergy to any study drug;
• 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;
• the American Society of anesthesiologists (ASA) classified the fifth grade patients (on the verge of death);
• nerve injury or brain organic pathological changes;
• participate in clinical research in the past 30 days;
• pregnancy or lactation;
• the researcher thinks it is not suitable to participate in the clinical trial.

Sponsors & Collaborators

• Jiangsu Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Hebei People's Hospital

Hebei, Hebei, China

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Butorphanol; Propofol; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Quansheng Q Du, doctor

  Hebei People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun J Ren, master

CONTACT

18205138967; renjun8967@163.com

Quansheng Q Du, doctor

CONTACT

13230163769; dqs888@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: March 20, 2020
• Study Start: December 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)