Efficacy and Safety of Remifentanil for Mechanically Ventilated Patients in ICU
NCT ID: NCT05003570
Last Updated: 2022-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
138 participants
INTERVENTIONAL
2021-06-10
2022-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Remifentanil
Remifentanil analgesia combined with propofol sedation. Treatment was started in patients with an CPOT score of 2 or greater after completion of baseline assessments. All patients received an initial infusion of blinded opioid (placebo bolus dose(6ml) + 6ug/kg per hour infusion at 6 ml/hour). Optimal analgesia (CPOT score ≤2) was then targeted by titrating the infusion in 1.5 ml/hour increments (placebo bolus dose + 1.5ug/kg per hour rate increase).
Remifentanil
Dosage forms and strengths: 3 mL Vial/1 mg lyophilized powder. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd
Fentanyl
Fentanyl analgesia combined with propofol sedation. Treatment was started in patients with an CPOT score of 2 or greater after completion of baseline assessments. All patients received an initial infusion of blinded opioid (1ug/kg bolus(6ml) + 1ug/kg per hour infusion at 6ml/hour). Optimal analgesia (CPOT score ≤2) was then targeted by titrating the infusion in 1.5 ml/hour increments (1ug/kg bolus dose + 0.25ug/kg per hour rate increase).
Fentanyl
Dosage forms and strengths: 50 mcg/mL Fentanyl base/10 mL ampules. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd
Interventions
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Remifentanil
Dosage forms and strengths: 3 mL Vial/1 mg lyophilized powder. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd
Fentanyl
Dosage forms and strengths: 50 mcg/mL Fentanyl base/10 mL ampules. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expected to continue mechanical ventilation for more than 12 hours
* Informed consent/assent was obtained from all patients or their representatives
Exclusion Criteria
* Patients who are known or suspected to be allergic to the study drug
* Patients whose expected survival time is less than 48h
* Patients receiving deep sedation (RASS≥-4)
* Patients using neuromuscular blocking agent
* Patients who cannot be assessed by RASS
* Patients with myasthenia gravis
* patients with bronchial asthma
* patients with abdominal compartment syndrome
* Patients who need surgery or tracheotomy during the study drug treatment period
* Women during pregnancy and lactation
* Patients who have used short-acting non-steroidal anti-inflammatory drugs within 6 hours
* Patients who have used long-acting non-steroidal anti-inflammatory drugs within 12 hours
* Patients with a history of chronic pain for more than 3 months or who are receiving regular analgesia for more than 3 months
* Patients who have used monoamine oxidase inhibitors within two weeks
* Patients who participate in any clinical trials as subjects within 1 month
* Patients with a history of drug abuse, drug abuse, alcohol abuse\* and long-term use of psychotropic drugs within 2 years Alcoholism: Drinking more than 14 times/week (1 time=150ml wine or 360ml beer or 45ml spirits)
18 Years
80 Years
ALL
No
Sponsors
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Southeast University, China
OTHER
Responsible Party
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Ling Liu
professor
Principal Investigators
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Yang Yi, MD
Role: STUDY_CHAIR
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Qingyuan People's Hospital
Qingyuan, Guangdong, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Enshi, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Zhong-Da Hospital, Southeast University
Nanjing, Jiangsu, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Pan Aijun, MD
Role: primary
Zhou Jianxin, MD
Role: primary
Zhou Fachun, MD
Role: primary
Yang Jingwen, MD
Role: primary
Shen Feng, MD
Role: primary
Chen Tao, MD
Role: primary
Hu Zhenjie, MD
Role: primary
Sun Tongwen, MD
Role: primary
Qin Bingyu, MD
Role: primary
Li Dezhong, MD
Role: primary
Gong Xun, MD
Role: primary
Yang Mingshi, MD
Role: primary
Zhang Lina, MD
Role: primary
Zheng Rui qiang, MD
Role: primary
Sun Renhua, MD
Role: primary
Pan Jingye, MD
Role: primary
Other Identifiers
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ZDRF
Identifier Type: -
Identifier Source: org_study_id
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