AnalgesiaPhase 3NCT05641909
Efficacy and Safety of Remifentanil for Mechanically Ventilated Patients in Intensive Care Unit
A Phase 3 study testing Remifentanil and Fentanyl in people with Analgesia, run by Southeast University, China at 18 sites in China.
Trial summary
Remifentanil has been approved by the FDA for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Remifentanil and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 18 sitesChina
- Study dates
- 1 Aug 2021to 31 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intubated in the past 24 hours with invasive mechanical ventilation
- Expected to continue mechanical ventilation for more than 48 hours
- Informed consent/assent was obtained from all patients or their representatives
Who cannot join
- Patients with a history of allergy to opioids, benzodiazepines, propofol, or alcohol/drug abuse were excluded from the study
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites, 18 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Zhou Jianxin, MD, +8613801183875
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Yang Mingshi, MD, +8613973139006
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Zhang Lina, MD, +8615874875763
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 404100
Zhou Fachun, MD, +8618502388799
- Recruiting
Enshi Tujia and Miao Autonomous Prefecture Central Hospital
Enshi, Hubei, 445000
Li Dezhong, MD, +8615342885588
- Recruiting
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Shen Feng, MD, +8613511999117
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000
Sun Renhua, MD, +8613505710366
- Recruiting
Anhui Provincial People's Hospital
Hefei, Anhui, 230000
Pan Aijun, MD, +8613866668786
- Recruiting
Nanjing Zhong-Da Hospital, Southeast University
Nanjing, 210009
Liu Ling, MD, +86-25-83262550, liulingdoctor@gmail.com
Yang Yi, MD, +86-25-83262552, yiyiyang2004@163.com
- Recruiting
Qingyuan People's Hospital
Qingyuan, Guangdong, 511500
Yang Jingwen, MD, +8613542498765
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Hu Zhenjie, MD, +8613933856908
- Recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 30000
Wang Yongqiang, MD, +8613302048899
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Peng Zhiyong, MD, +8618672396028
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710000
Shi Qindong, MD, +8618991232391
- Recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000
Zheng Rui qiang, MD, +8613952721411
- Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Sun Tongwen, MD, +8613838516916
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Qin Bingyu, MD, +8613633810677
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Chen Tao, MD, +8615329112288
About this study
Official title: Efficacy and Safety of Remifentanil for Mechanically Ventilated Patients in Intensive Care: Multicenter, Random, Double-blind, Parallel, Positive Control Clinical Trials
Remifentanil has been approved by the FDA for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. However, National Medical Products Administration(NMPA) did not approve this indication. Therefore, the purpose of this study is to confirm the efficacy and safety of remifentanil in the analgesic therapy of critical ill patients in China.
Read the detailed description
The study was conducted in accordance with good clinical practice and with the guidelines set out in the Declaration of Helsinki. After approval from local and national ethics committees, patients from 18 centres in China were recruited. All patients were randomized, in a double-blind manner, to receive either a remifentanil-propofol regimen or a fentanyl-propofol regimen for analgesia and sedation in the ICU. The aim of the study was to achieve optimal sedation and patient comfort by maintaining an optimal Critical Care Pain Observation Tool (CPOT) score of 2, without clinically significant pain, until the start of the extubation process or for 72 hours, whichever occurred first. CPOT scoring criteria: Facial expressions(Relaxed, neutral=0; Tense=1; Grimacing=2); Body movements(Absence of movements or normal position=0; Protection=1; Restlessness/Agitation=2); Muscle tension(Relaxed=0; Tense, rigid=1; Very tense or rigid=2); Compliance with the ventilator or Vocalization(Tolerating ventilator or movement/Talking in normal tone or no sound=0; Coughing but tolerating/Sighing, moaning=1; Fighting ventilator/Crying out, sobbing=2).
- Conditions
- Analgesia
- Being tested
- Remifentanil, Fentanyl
- Keywords
- analgesia, analgesia based sedation, critical care, fentanyl, propofol, remifentanil, sedation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Remifentanil Hydrochloride for Injection
Remifentanil
FentanylDrug
Also called Fentanyl Citrate Injection
Dosage forms and strengths: 50 mcg/mL Fentanyl base/10 mL ampules. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Experimental | 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). Only when the opioid infusion rate had reached the 'propofol trigger dose' (12ml/h; 12ug/ kg per hour) was propofol to be administered as an initial bolus dose of up to 0.5 mg/kg and an infusion of 0.5mg/kg per hour, and titrated in 25% increments (0.25mg/kg bolus dose + 0.125mg/kg per hour rate increase to treat agitation. Receives: Drug: Remifentanil |
| Fentanyl | Active comparator | 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). Only when the opioid infusion rate had reached the 'propofol trigger dose' (12ml/h; 2ug/kg per hour) was propofol to be administered as an initial bolus dose of up to 0.5 mg/kg and an infusion of 0.5mg/kg per hour, and titrated in 25% increments (0.25mg/kg bolus dose + 0.125mg/kg per hour rate increase to treat agitation. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesia success rate(the proportion of subjects with successful analgesia to the number of subjects in each group)
Analgesia success is defined as: 1. No salvage analgesics were used during the administration of the study drug; 2 During the administration of the study drug, the time for the analgesia score of subjects to reach the standard (CPOT score ≤ 2) was greater than 70%. CPOT scoring criteria: Facial expressions(Relaxed, neutral=0; Tense=1; Grimacing=2); Body movements(Absence of movements or normal position=0; Protection=1; Restlessness/ Agitation=2); Muscle tension(Relaxed=0; Tense, rigid=1; Very tense or rigid=2); Compliance with the ventilator or Vocalization(Tolerating ventilator or movement/Talking in normal tone or no sound=0; Coughing but tolerating/Sighing, moaning=1; Fighting ventilator/Crying out, sobbing=2).
Measured: From study drug administration to actual extubation , up to 72 hours
Secondary outcomes (17)
During the study drug administration period, the subjects are in the proportion of optimal time(CPOT score≤2)
CPOT scoring criteria: Facial expressions(Relaxed, neutral=0; Tense=1; Grimacing=2); Body movements(Absence of movements or normal position=0; Protection=1; Restlessness/Agitation=2); Muscle tension(Relaxed=0; Tense, rigid=1; Very tense or rigid=2); Compliance with the ventilator or Vocalization(Tolerating ventilator or movement/Talking in normal tone or no sound=0; Coughing but tolerating/Sighing, moaning=1; Fighting ventilator/Crying out, sobbing=2).
Measured: From study drug administration to actual extubation , up to 72 hours
The number of times the remedial sedative drug propofol was used
Use the total times of propofol
Measured: From study drug administration to actual extubation , up to 72 hours
The proportion of subjects using the salvage sedative drug propofol
The proportion of subjects who using the salvage sedative drug propofol to the total subjects.
Measured: From study drug administration to actual extubation , up to 72 hours
The dosage of the remedial sedative drug propofol
Use the total dose of propofol
Measured: From study drug administration to actual extubation , up to 72 hours
Wearing time from mechanical ventilation
Wearing time criteria: The primary disease is improved, and there is no new disease; no use of vasopressors or continuous application of sedative drugs; cough reflex during sputum suction; PEEP≤5cmH2O; PaO2/FiO2≥200mmHg; Minute ventilation less than 15L/min; 2-minute spontaneous breathing test and passed.
Measured: From study drug administration to wearing from mechanical ventilation, up to 72 hours
Extubation time
The start of the extubation process until actual extubation
Measured: From the start of the extubation process until actual extubation , up to 72 hours
The success rate of wearing mechanical ventilator
The proportion of subjects who successfully wearing from mechanical ventilator to the total subjects.
Measured: From study drug administration to actual extubation , up to 72 hours
Duration of study drug use in ICU
The time from the start of the study drug administration to the time discharge ICU.
Measured: Through study completion, an average of 1 month
The proportion of subjects discharging the ICU
The proportion of subjects who discharge ICU to the total subjects.
Measured: Through study completion, an average of 1 month
ICU mortality
The proportion of subjects who died during ICU admission to the total subjects.
Measured: Through study completion, an average of 1 month
Hospital mortality
The proportion of subjects who died during hospital admission to the total subjects.
Measured: Through study completion, an average of 1 month
Length of ICU stay
The number of days the subject stayed in the ICU.
Measured: Through study completion, an average of 1 month
Length of hospital stay
The number of days the subject stayed in the hospital.
Measured: Through study completion, an average of 1 month
The incidence of study drug-related Lower blood pressure
Lower blood pressure: mean arterial pressure (MAP) drops more than 25% from the baseline level or requires additional vasopressors.
Measured: From study drug administration to actual extubation , up to 72 hours
The incidence of study drug-related slow heart rate
Slow heart rate: heart rate less than 40bpm for less than 1 minute or heart rate less than 60 bpm for more than 1 minute.
Measured: From study drug administration to actual extubation , up to 72 hours
The incidence of study drug-related respiratory depression
Respiratory depression: respiratory rate less than 10 bpm or oxygen saturation by pulse oximetry less than 90%
Measured: From study drug administration to actual extubation , up to 72 hours
Analysis of the cost-effectiveness between remifentanil and fentanyl
Analyze the best analgesic plan based on the results of the best analgesic effect
Measured: From study drug administration to actual extubation , up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Aug 2021
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songqiao Liu, Southeast University, China
- Investigators
- Yang Yi, MD, Study chair, Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641909
- Sponsor's protocol ID
- ZDRFF
- Status last verified
- Nov 2022
- First submitted
- 29 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Remifentanil for Mechanically Ventilated Patients in Intensive Care: Multicenter, Random, Double-blind, Parallel, Positive Control Clinical Trials
- ClinicalTrials.gov ID
- NCT05641909
- Acronym / sponsor ID
- ZDRFF
- Conditions
- Analgesia
- Keywords
- analgesia, analgesia based sedation, critical care, fentanyl, propofol, remifentanil, sedation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Remifentanil has been approved by the FDA for continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. However, National Medical Products Administration(NMPA) did not approve this indication. Therefore, the purpose of this study is to confirm the efficacy and safety of remifentanil in the analgesic therapy of critical ill patients in China.
Detailed description
The study was conducted in accordance with good clinical practice and with the guidelines set out in the Declaration of Helsinki. After approval from local and national ethics committees, patients from 18 centres in China were recruited. All patients were randomized, in a double-blind manner, to receive either a remifentanil-propofol regimen or a fentanyl-propofol regimen for analgesia and sedation in the ICU. The aim of the study was to achieve optimal sedation and patient comfort by maintaining an optimal Critical Care Pain Observation Tool (CPOT) score of 2, without clinically significant pain, until the start of the extubation process or for 72 hours, whichever occurred first. CPOT scoring criteria: Facial expressions(Relaxed, neutral=0; Tense=1; Grimacing=2); Body movements(Absence of movements or normal position=0; Protection=1; Restlessness/Agitation=2); Muscle tension(Relaxed=0; Tense, rigid=1; Very tense or rigid=2); Compliance with the ventilator or Vocalization(Tolerating ventilator or movement/Talking in normal tone or no sound=0; Coughing but tolerating/Sighing, moaning=1; Fighting ventilator/Crying out, sobbing=2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Experimental | Drug: RemifentanilRemifentanil 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). Only when the opioid infusion rate had reached the 'propofol trigger dose' (12ml/h; 12ug/ kg per hour) was propofol to be administered as an initial bolus dose of up to 0.5 mg/kg and an infusion of 0.5mg/kg per hour, and titrated in 25% increments (0.25mg/kg bolus dose + 0.125mg/kg per hour rate increase to treat agitation. |
| Fentanyl | Active comparator | Drug: FentanylFentanyl 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). Only when the opioid infusion rate had reached the 'propofol trigger dose' (12ml/h; 2ug/kg per hour) was propofol to be administered as an initial bolus dose of up to 0.5 mg/kg and an infusion of 0.5mg/kg per hour, and titrated in 25% increments (0.25mg/kg bolus dose + 0.125mg/kg per hour rate increase to treat agitation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Intubated in the past 24 hours with invasive mechanical ventilation
- Expected to continue mechanical ventilation for more than 48 hours
- Informed consent/assent was obtained from all patients or their representatives
Key exclusion criteria (17 listed)
- Patients with a history of allergy to opioids, benzodiazepines, propofol, or alcohol/drug abuse were excluded from the study
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilAlso: Remifentanil Hydrochloride for InjectionRemifentanil | Drug | Remifentanil |
| FentanylAlso: Fentanyl Citrate InjectionDosage forms and strengths: 50 mcg/mL Fentanyl base/10 mL ampules. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd | Drug | Fentanyl |
Primary outcome
analgesia success rate(the proportion of subjects with successful analgesia to the number of subjects in each group)
Time frame: From study drug administration to actual extubation , up to 72 hours
Analgesia success is defined as: 1. No salvage analgesics were used during the administration of the study drug; 2 During the administration of the study drug, the time for the analgesia score of subjects to reach the standard (CPOT score ≤ 2) was greater than 70%. CPOT scoring criteria: Facial expressions(Relaxed, neutral=0; Tense=1; Grimacing=2); Body movements(Absence of movements or normal position=0; Protection=1; Restlessness/ Agitation=2); Muscle tension(Relaxed=0; Tense, rigid=1; Very tense or rigid=2); Compliance with the ventilator or Vocalization(Tolerating ventilator or movement/Talking in normal tone or no sound=0; Coughing but tolerating/Sighing, moaning=1; Fighting ventilator/Crying out, sobbing=2).
17 secondary outcomes
During the study drug administration period, the subjects are in the proportion of optimal time(CPOT score≤2)
Time frame: From study drug administration to actual extubation , up to 72 hours
The number of times the remedial sedative drug propofol was used
Time frame: From study drug administration to actual extubation , up to 72 hours
The proportion of subjects using the salvage sedative drug propofol
Time frame: From study drug administration to actual extubation , up to 72 hours
The dosage of the remedial sedative drug propofol
Time frame: From study drug administration to actual extubation , up to 72 hours
Wearing time from mechanical ventilation
Time frame: From study drug administration to wearing from mechanical ventilation, up to 72 hours
Extubation time
Time frame: From the start of the extubation process until actual extubation , up to 72 hours
The success rate of wearing mechanical ventilator
Time frame: From study drug administration to actual extubation , up to 72 hours
Duration of study drug use in ICU
Time frame: Through study completion, an average of 1 month
The proportion of subjects discharging the ICU
Time frame: Through study completion, an average of 1 month
ICU mortality
Time frame: Through study completion, an average of 1 month
Hospital mortality
Time frame: Through study completion, an average of 1 month
Length of ICU stay
Time frame: Through study completion, an average of 1 month
Length of hospital stay
Time frame: Through study completion, an average of 1 month
The incidence of study drug-related Lower blood pressure
Time frame: From study drug administration to actual extubation , up to 72 hours
The incidence of study drug-related slow heart rate
Time frame: From study drug administration to actual extubation , up to 72 hours
The incidence of study drug-related respiratory depression
Time frame: From study drug administration to actual extubation , up to 72 hours
Analysis of the cost-effectiveness between remifentanil and fentanyl
Time frame: From study drug administration to actual extubation , up to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Yi, MD study chair
Department of Critical Care Medicine, Zhongda Hospital, School of Medicine, Southeast University
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remifentanil and Fentanyl in people with Analgesia, run by Southeast University, China at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonqiao Liu, MD (+86-25-83262552, liusongqiao@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesia success rate(the proportion of subjects with successful analgesia to the number of subjects in each group) (time frame: From study drug administration to actual extubation , up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.