Effect of Different Sedation and Analgesia Strategies on Patients With Mechanical Ventilation

NCT05024799 | Unknown Phase 4

• 1 other identifier: QYFYKYLL931311920
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Most patients in ICU are treated with a combination of analgesics and sedatives in most cases. Due to the different mechanism of different sedative and analgesic drugs, different antagonistic or synergistic effects may occur when combined with drugs, resulting in different clinical effects, especially significant effects on ventilators for patients with assisted breathing. Therefore, this study hopes to compare the effects of different sedative and analgesic drug combinations on the duration of mechanical ventilation for patients with ventilators, so as to guide the clinical adoption of a more reasonable sedative and analgesic scheme.

Conditions

Respiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

• ventilator-free days at 28 days

  at 28 days

Study Arms (4)

F-P group

EXPERIMENTAL

the combination of fentanyl and propofol

Drug: Fentanyl, propofol

F-D group

EXPERIMENTAL

the combination of fentanyl and dexmedetomidine

Drug: fentanyl and dexmedetomindine

B-P group

EXPERIMENTAL

the combination of butorphanol and propofol

Drug: Butorphanol and propofol

B-D group

EXPERIMENTAL

the combination of butorphanol and dexmedetomidine

Drug: Butorphanol and dexmedetomindine

Interventions

Fentanyl, propofol DRUG

The patients in this group will be administered with fentanyl and propofol

F-P group

fentanyl and dexmedetomindine DRUG

The patients in this group will be administered with fentanyl and dexmedetomindine

F-D group

Butorphanol and propofol DRUG

The patients in this group will be administered with butorphanol and propofol

B-P group

Butorphanol and dexmedetomindine DRUG

The patients in this group will be administered with butorphanol and dexmedetomindine

B-D group

Eligibility Criteria

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

You may qualify if:

• Adults who are treated with sedation and analgesia for invasive mechanical ventilation

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Fentanyl; Propofol; Butorphanol

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Jinyan Xing, Dr

CONTACT

86-0532-82919386; xingjy@qdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 27, 2021
• Study Start: January 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 27, 2021

Record last verified: 2021-08