Back to resultsEffect of Different Sedation and Analgesia Strategies on Patients With Mechanical Ventilation
Primary Purpose
Respiratory Insufficiency
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fentanyl, propofol
fentanyl and dexmedetomindine
Butorphanol and propofol
Butorphanol and dexmedetomindine
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Adults who are treated with sedation and analgesia for invasive mechanical ventilation
Exclusion Criteria:
- they have baseline severe cognitive impairment; were pregnant or breast-feeding; were blind, deaf ; had second-degree or third-degree heart block or bradycardia requiring intervention; had an allergy to the experimental drugs; had an indication for benzodiazepines; were anticipated to have immediate discontinuation of mechanical ventilation; were expected to have neuromuscular blockade for more than 48 hours; were in a moribund state; or had received mechanical ventilation for more than 96 hours before meeting all inclusion criteria.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
F-P group
F-D group
B-P group
B-D group
Arm Description
the combination of fentanyl and propofol
the combination of fentanyl and dexmedetomidine
the combination of butorphanol and propofol
the combination of butorphanol and dexmedetomidine
Outcomes
Primary Outcome Measures
ventilator-free days at 28 days
Secondary Outcome Measures
Full Information
NCT ID
NCT05024799
First Posted
August 23, 2021
Last Updated
August 26, 2021
Sponsor
The Affiliated Hospital of Qingdao University
1. Study Identification
Unique Protocol Identification Number
NCT05024799
Brief Title
Effect of Different Sedation and Analgesia Strategies on Patients With Mechanical Ventilation
Official Title
Effect of Different Sedation and Analgesia Strategies on Patients With Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Hospital of Qingdao University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
F-P group
Arm Type
Experimental
Arm Description
the combination of fentanyl and propofol
Arm Title
F-D group
Arm Type
Experimental
Arm Description
the combination of fentanyl and dexmedetomidine
Arm Title
B-P group
Arm Type
Experimental
Arm Description
the combination of butorphanol and propofol
Arm Title
B-D group
Arm Type
Experimental
Arm Description
the combination of butorphanol and dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
Fentanyl, propofol
Intervention Description
The patients in this group will be administered with fentanyl and propofol
Intervention Type
Drug
Intervention Name(s)
fentanyl and dexmedetomindine
Intervention Description
The patients in this group will be administered with fentanyl and dexmedetomindine
Intervention Type
Drug
Intervention Name(s)
Butorphanol and propofol
Intervention Description
The patients in this group will be administered with butorphanol and propofol
Intervention Type
Drug
Intervention Name(s)
Butorphanol and dexmedetomindine
Intervention Description
The patients in this group will be administered with butorphanol and dexmedetomindine
Primary Outcome Measure Information:
Title
ventilator-free days at 28 days
Time Frame
at 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults who are treated with sedation and analgesia for invasive mechanical ventilation
Exclusion Criteria:
they have baseline severe cognitive impairment; were pregnant or breast-feeding; were blind, deaf ; had second-degree or third-degree heart block or bradycardia requiring intervention; had an allergy to the experimental drugs; had an indication for benzodiazepines; were anticipated to have immediate discontinuation of mechanical ventilation; were expected to have neuromuscular blockade for more than 48 hours; were in a moribund state; or had received mechanical ventilation for more than 96 hours before meeting all inclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinyan Xing, Dr
Phone
86-0532-82919386
Ext
82919386
Email
xingjy@qdu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Different Sedation and Analgesia Strategies on Patients With Mechanical Ventilation
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