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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Insufficiency
• Intervention / Treatment: Drug: Fentanyl, propofol; Drug: fentanyl and dexmedetomindine; Drug: Butorphanol and propofol; Drug: Butorphanol and dexmedetomindine

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jinyan Xing, Dr; Phone Number: 82919386 86-0532-82919386; Email: xingjy@qdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F-P group; the combination of fentanyl and propofol	Drug: Fentanyl, propofol; The patients in this group will be administered with fentanyl and propofol
Experimental: F-D group; the combination of fentanyl and dexmedetomidine	Drug: fentanyl and dexmedetomindine; The patients in this group will be administered with fentanyl and dexmedetomindine
Experimental: B-P group; the combination of butorphanol and propofol	Drug: Butorphanol and propofol; The patients in this group will be administered with butorphanol and propofol
Experimental: B-D group; the combination of butorphanol and dexmedetomidine	Drug: Butorphanol and dexmedetomindine; The patients in this group will be administered with butorphanol and dexmedetomindine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ventilator-free days at 28 days	at 28 days

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 26, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Narcotic Antagonists; Respiratory System Agents; Antitussive Agents; Fentanyl; Propofol; Butorphanol
• Other Study ID Numbers: QYFYKYLL931311920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No