analgesia
Conditions
Interventions
Experimental group:Initial dose: Fentanyl analog injection (6 ml)+6 µ g/kg/h infusion (infusion rate of 6 ml/h)
Continuous infusion: The dosage adjustment during administration is 1.5 µ g/kg/h (rate adjustment is 1.5 ml/h), and the adjustment frequency is once every 5 minutes.
control group:Initial dose: 1 µ g/kg push injection (6 ml)+1 µ g/kg/h infusion (infusion rate of 6 ml/h)
Continuous infusion: The dosage adjustment during administration is 0.25 µ g/kg/h (rate adjustment is 1.5 ml/h), and the adjustment frequency is once every 5 minutes.
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Male or female subjects aged between 18 and 80 years old, with a body mass index (BMI) within the range of 18.0-30.0 kg/m^2 (including the critical value); 2) The postoperative patient is expected to require mechanical ventilation for at least 12 hours after entering the ICU; 3) The patient or their family members have a full understanding of the purpose and significance of this trial, understand and comply with the requirements of this study, voluntarily participate in this clinical trial, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Those who are known or suspected to be allergic or contraindicated to various components of the experimental drugs involved in the research; 2) Patients who are unable to undergo RASS (evaluation method detailed in Appendix 1) assessment due to various reasons; 3) Individuals with a history of myasthenia gravis; 4) Individuals with a history of bronchial asthma; 5) Individuals with a history of abdominal compartment syndrome; 6) Severe liver function abnormalities [Child Pugh grading is C (10-15 points) (evaluation method detailed in Appendix 2)]; 7) Patients with hemodynamic instability (MAP= 65 mmHg); 8) Patients who require deep sedation (RASS=-4 or -5, evaluation method detailed in Appendix 1) or the use of neuromuscular blockade drugs; 9) Patients who have used monoamine oxidase inhibitors (see Appendix 3 for details) within the two weeks prior to enrollment; 10) Patients who require reoperation or tracheotomy during the study of drug therapy; 11) Individuals who have a history of drug abuse, drug use, severe alcohol abuse within 2 years prior to the start of the screening period, as well as those who have been regularly taking (continuously taking for more than 30 days) psychotropic drugs within 3 months prior to the screening period; 12) Pregnant or lactating women or those with family planning within 3 months (including male participants); 13) Participate as a participant in any clinical trial (including drug or device clinical trials) within one month prior to enrollment; 14) Other situations deemed unsuitable for inclusion by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain relief success rat; | — |
Secondary
| Measure | Time frame |
|---|---|
| During the study drug administration period, the proportion of time subjects were in CPOT <= 2 points and -2 points <= RASS <= 1 point;;The frequency of administration of the remedial sedative propofol medium/long-chain fat emulsion injection;;The proportion of subjects using the remedial sedative propofol medium/long-chain fat emulsion injection;;Dosage of sedatives propofol medium/long-chain fat emulsion injection;;Study the time from the start of drug administration to the departure from mechanical ventilation;;Offline success rate;Study the time from the start of drug administration to the time of discharge from the ICU;;The proportion of subjects leaving the ICU.; | — |
Countries
China
Contacts
Public ContactXiangdong Guan
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed