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

March 18, 2020 updated by: Jiangsu Hengrui Pharmaceutical Co., Ltd.

Comparison of Analgesic Effect and Prognosis of Butorphanol and Fentanyl in Patients With Mechanical Ventilation: a Prospective, Randomized, Multicenter Clinical Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For enrolled patients, the investigators required that inclusion criteria were informed consent signed.The exclusion criteria were described in detail in the CRF standard. The recruitment of patients into the group were conducted in each sub-center according to Inclusion criteria. After the inclusion of patients will registed relevant information according to the basic data table of patients, disease information table and baseline data table, and then randomly divide the patients into groups by special statistician (CRA/CRO).The relevant data in the clinical study were collected by specialized nurses or data recording team.The daily statistical results need to record and dated by statisticians in order to track the authenticity and reliability of the data. The statistician should communicate with the doctor in charge about the situation out the trial plan during the study. If there is any change in the test plan, it is necessary to mark the measures and reasons for the change in detail, and sign the signature and date of the statistician and the responsible doctor in the statistical table of the day. The recorded data of the study should be updated with electronic documents. Statistical recorder of data need to make weekly summary, summarize and submit the statistical data of last month at each sub-research center at the beginning of each month, then the lead hospital will summarize and analyze the data.As for the problems beyond the experimental schemes in the research process, each branch center needs to discuss with the lead center. Every three months, progress meetings will be held to discuss various problems in clinical research and to unify standards for related problems to ensure the smooth progress of clinical research and the true reliability of experimental results. SAS 9.4 software was used for statistical analysis. The analysis content included subject distribution description, baseline index balance analysis, efficacy analysis and safety analysis.The significance level of the statistical test was α=0.05. In the safety analysis, the incidence of adverse events and adverse reactions was calculated and the specific conditions of all subjects with adverse events were listed. The list of vital signs and normal abnormalities in laboratory examination before and after medication was described, and the specific conditions of subjects with abnormal conditions before and after treatment and abnormal conditions before and after treatment were listed in detail.After completing the statistical analysis, the statistical analyst should record the data and submit it to the main researcher of the experiment to fill with the general analysis report. All cases, whether observation or shedding, should be completed in accordance with the requirements of "case report form". The case report form were copied three copies with without carbon copy. After the completion of data entry, the sponsor (the first copy), the unit in charge of the clinical research (the second copy) and the clinical research unit (the third copy) shall file it respectively.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
355

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Quansheng Q Du, doctor
  • Phone Number: 13230163769 13230163769
  • Email: dqs888@126.com

Study Locations

  • China
    • Hebei
      • Hebei, Hebei, China
        • Recruiting
        • Hebei People's Hospital
        • Contact:
          • Quansheng Q Du, doctor
          • Phone Number: 13230163769 +86 13230163769
          • Email: dqs888@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. known allergy to any study drug;
  2. 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;
  3. the American Society of anesthesiologists (ASA) classified the fifth grade patients (on the verge of death);
  4. nerve injury or brain organic pathological changes;
  5. participate in clinical research in the past 30 days;
  6. pregnancy or lactation;
  7. the researcher thinks it is not suitable to participate in the clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: butorphanol group
Butorphanol (10-20 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation
Drug: Butorphanol and Propofol
The two groups were given propofol for sedation, BG for butorphanol for analgesia and FG for fentanyl for analgesia
ACTIVE_COMPARATOR: fentanyl group
Fentanyl (0.7-10 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation
Drug: Fentanyl and Propofol
Fentanyl (0.7-10 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analgesic score,
Time Frame: Maintain target analgesia score (CPOT<3) from 100% time to 80% time
Analgesia score (CPOT < 3 points)
Maintain target analgesia score (CPOT<3) from 100% time to 80% time
sedative score
Time Frame: Maintain target analgesia score (CPOT<3) from 100% time to 80% time
APACHE II score, SOFA score,
Maintain target analgesia score (CPOT<3) from 100% time to 80% time
Total dosage of butorphanol， fentanyl，propofol;
Time Frame: Maintain target analgesia score (CPOT<3) from 100% time to 80% time
The specific dosage of butorphanol, fentanyl and propofol,
Maintain target analgesia score (CPOT<3) from 100% time to 80% time

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major indicators affecting the prognosis of patients in ICU
Time Frame: From day 1 to day 30
pulling time, ICU stay time, invasive mechanical ventilation time, length of stay, 30 day mortality
From day 1 to day 30

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse reactions
Time Frame: From day 1 to day 30
The percentages of delirium, respiratory depression, hypotension, tachycardia, pneumonia, intestinal obstruction, renal failure, wound infection, and nausea/vomiting were recorded in different groups,
From day 1 to day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Hengrui Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Quansheng Q Du, doctor, Hebei People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SINGCHN-BUT-IV-1902

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The clinical study data of this project were owned by the participating research center. For other researchers who need data, the results of the study can be understood through the literature published later.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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