Critical IllnessPhase 4NCT02635802
the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation
A Phase 4 study testing Remifentanil, Lidocaine and Remifentanil+Lidocaine in people with Critical Illness, run by The First Affiliated Hospital of Zhengzhou University.
Trial summary
Remifentanil is one kind of opiates with strong analgesic effect,which has the rapid onset and short lasting duration. Remifentanil usually is used to help reducing the pain of patients with mechanical ventilation in ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Remifentanil, Lidocaine and Remifentanil+Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Sep 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- critically ill patients need endotracheal intubation
- tracheotomy
- central venous puncture
- pleural puncture
- abdominal puncture
- lumbar puncture
Show all 9Show fewer
- bone marrow puncture
- fiber bronchoscopic examination
- other small short-time operations
Who cannot join
- patients allergic to opioids
- in pregnancy or in feeding
- with myasthenia gravis
- with hypovolemia,
- take monoamine oxidase inhibitor(MAOI) in 14days
- in coma and GCS<8
- with bradycardia or hypotension
About this study
Remifentanil is one kind of opiates with strong analgesic effect,which has the rapid onset and short lasting duration. Remifentanil usually is used to help reducing the pain of patients with mechanical ventilation in ICU. Maybe it can also be used to ease the pain in ICU small short time operation.The purpose of this study is to determine (1) whether remifentanil is effective in small short time operations in ICU or not, (2) the save range of remifentanil in small short time operations in ICU, (3) and the adverse reaction that happens in these operations.
- Conditions
- Critical Illness
- Being tested
- Remifentanil, Lidocaine, Remifentanil+Lidocaine, Midazolam
- Keywords
- remifentanil, analgesia, intensive care units
- Medical subject headings
- Critical Illness, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
a loading dose 1.0-2.0μg/kg remifentanil,intravenous injection slowly,time >1min,then 5μg/kg·h pumping if the operation can not be done in 5 minutes.
Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after the loading.We should maintain the CPOT≤2 and RASS 0～2,if it is not up to the standard,increasing the pumping rate 0.5 μg/kg·h every 2-5min.
LidocaineDrug
lidocaine 100-400mg,local anesthesia.Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after local anesthesia.We should maintain the CPOT≤2 and RASS 0～2.
Remifentanil+LidocaineDrug
a loading dose 1.0-2.0μg/kg remifentanil,intravenous injection slowly,time >1min,then 5μg/kg·h remifentanil pumping immediately if the operation can not be done in 5 minutes.then local anesthesia with lidocaine 100-400mg.Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after anesthesia.We should maintain the CPOT≤2 and RASS 0～2,if it is not up to the standard,increasing the pumping rate 0.5μg/kg·h every 2-5min.
MidazolamDrug
midazolam is an adjuvant drug.we should maintain the CPOT≤2 and RASS 0～2,if lidocaine is already used up to 400mg or the pumping rate of remifentanil is already 7.5μg/kg·h,then we should use midazolam 3mg, intravenous injection slowly.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Experimental | injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished. Receives: Drug: Remifentanil; Drug: Midazolam |
| Lidocaine | Experimental | injection form concentration 10mg/ml loading dose 100-400mg local anesthesia Receives: Drug: Lidocaine; Drug: Midazolam |
| Remifentanil+Lidocaine | Experimental | injection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished
+ injection form concentration 10mg/ml loading dose 100-400mg local anesthesia Receives: Drug: Remifentanil+Lidocaine; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital signs change
heart rate, respiration rate
Measured: baseline, intraoperative and 10mins after operation
vital signs change
respiration rate
Measured: baseline, intraoperative and 10mins after operation
vital signs change
blood oxygen saturation of artery blood of finger(SpO2)
Measured: baseline, intraoperative and 10mins after operation
vital signs change
mean blood pressure
Measured: baseline, intraoperative and 10mins after operation
vital signs change
Critical-Care Observation Tool(CPOT)
Measured: baseline, intraoperative and 10mins after operation
vital signs change
Richmond Agitation-Sedation Scale(RASS)
Measured: baseline, intraoperative and 10mins after operation
Secondary outcomes (1)
number of adverse reaction
respiratory depression,skeletal muscle stiffness,nausea vomting and dizziness,hypertension,allergy,bradycardia etc.
Measured: baseline,intraoperative,10mins after operation,30mins after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Responsible party
- Principal investigator, Rongqi Sun, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635802
- Sponsor's protocol ID
- zdyfysicu-1
- Status last verified
- Dec 2015
- First submitted
- 6 Dec 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Evane TN, Park GR. Remifentanil in the critically ill. Anaesthesia. 1997 Aug;52(8):800-1. No abstract available.
PubMed 9291773Soltesz S, Biedler A, Silomon M, Schopflin I, Molter GP. Recovery after remifentanil and sufentanil for analgesia and sedation of mechanically ventilated patients after trauma or major surgery. Br J Anaesth. 2001 Jun;86(6):763-8. doi: 10.1093/bja/86.6.763.
PubMed 11573581Wilhelm W, Dorscheid E, Schlaich N, Niederprum P, Deller D. [The use of remifentanil in critically ill patients. Clinical findings and early experience]. Anaesthesist. 1999 Sep;48(9):625-9. doi: 10.1007/s001010050762. German.
PubMed 10525595Wilhelm W, Kreuer S. The place for short-acting opioids: special emphasis on remifentanil. Crit Care. 2008;12 Suppl 3(Suppl 3):S5. doi: 10.1186/cc6152. Epub 2008 May 14.
PubMed 18495056Casey E, Lane A, Kuriakose D, McGeary S, Hayes N, Phelan D, Buggy D. Bolus remifentanil for chest drain removal in ICU: a randomized double-blind comparison of three modes of analgesia in post-cardiac surgical patients. Intensive Care Med. 2010 Aug;36(8):1380-5. doi: 10.1007/s00134-010-1836-2. Epub 2010 Mar 18.
PubMed 20237760Chalumeau-Lemoine L, Stoclin A, Billard V, Laplanche A, Raynard B, Blot F. Flexible fiberoptic bronchoscopy and remifentanil target-controlled infusion in ICU: a preliminary study. Intensive Care Med. 2013 Jan;39(1):53-8. doi: 10.1007/s00134-012-2697-7. Epub 2012 Sep 28.
PubMed 23052952Al MJ, Hakkaart L, Tan SS, Bakker J. Cost-consequence analysis of remifentanil-based analgo-sedation vs. conventional analgesia and sedation for patients on mechanical ventilation in the Netherlands. Crit Care. 2010;14(6):R195. doi: 10.1186/cc9313. Epub 2010 Nov 1.
PubMed 21040558Futier E, Chanques G, Cayot Constantin S, Vernis L, Barres A, Guerin R, Chartier C, Perbet S, Petit A, Jabaudon M, Bazin JE, Constantin JM. Influence of opioid choice on mechanical ventilation duration and ICU length of stay. Minerva Anestesiol. 2012 Jan;78(1):46-53. Epub 2011 Nov 5.
PubMed 21971434Battershill AJ, Keating GM. Remifentanil : a review of its analgesic and sedative use in the intensive care unit. Drugs. 2006;66(3):365-85. doi: 10.2165/00003495-200666030-00013.
PubMed 16526829Karabinis A, Mandragos K, Stergiopoulos S, Komnos A, Soukup J, Speelberg B, Kirkham AJ. Safety and efficacy of analgesia-based sedation with remifentanil versus standard hypnotic-based regimens in intensive care unit patients with brain injuries: a randomised, controlled trial [ISRCTN50308308]. Crit Care. 2004 Aug;8(4):R268-80. doi: 10.1186/cc2896. Epub 2004 Jun 28.
PubMed 15312228
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation
- ClinicalTrials.gov ID
- NCT02635802
- Acronym / sponsor ID
- zdyfysicu-1
- Conditions
- Critical Illness
- Keywords
- remifentanil, analgesia, intensive care units
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Yichang Humanwell Pharmaceutical Co., Ltd., China
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 21 Dec 2015 (estimated)
- 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 is one kind of opiates with strong analgesic effect,which has the rapid onset and short lasting duration. Remifentanil usually is used to help reducing the pain of patients with mechanical ventilation in ICU. Maybe it can also be used to ease the pain in ICU small short time operation.The purpose of this study is to determine (1) whether remifentanil is effective in small short time operations in ICU or not, (2) the save range of remifentanil in small short time operations in ICU, (3) and the adverse reaction that happens in these operations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Experimental | Drug: Remifentanil, Drug: Midazolaminjection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished. |
| Lidocaine | Experimental | Drug: Lidocaine, Drug: Midazolaminjection form concentration 10mg/ml loading dose 100-400mg local anesthesia |
| Remifentanil+Lidocaine | Experimental | Drug: Remifentanil+Lidocaine, Drug: Midazolaminjection form concentration 20μg/ml loading dose 1.0-2.0μg/kg intravenous injection slowly,time >1min,then 5μg/kg·h pumping until the operation is finished + injection form concentration 10mg/ml loading dose 100-400mg local anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- critically ill patients need endotracheal intubation
- tracheotomy
- central venous puncture
- pleural puncture
- abdominal puncture
Key exclusion criteria (7 listed)
- patients allergic to opioids
- in pregnancy or in feeding
- with myasthenia gravis
- with hypovolemia,
- take monoamine oxidase inhibitor(MAOI) in 14days
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 |
|---|---|---|
| Remifentanila loading dose 1.0-2.0μg/kg remifentanil,intravenous injection slowly,time >1min,then 5μg/kg·h pumping if the operation can not be done in 5 minutes. Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after the loading.We should maintain the CPOT≤2 and RASS 0～2,if it is not up to the standard,increasing the pumping rate 0.5 μg/kg·h every 2-5min. | Drug | Remifentanil |
| Lidocainelidocaine 100-400mg,local anesthesia.Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after local anesthesia.We should maintain the CPOT≤2 and RASS 0～2. | Drug | Lidocaine |
| Remifentanil+Lidocainea loading dose 1.0-2.0μg/kg remifentanil,intravenous injection slowly,time >1min,then 5μg/kg·h remifentanil pumping immediately if the operation can not be done in 5 minutes.then local anesthesia with lidocaine 100-400mg.Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after anesthesia.We should maintain the CPOT≤2 and RASS 0～2,if it is not up to the standard,increasing the pumping rate 0.5μg/kg·h every 2-5min. | Drug | Remifentanil+Lidocaine |
| Midazolammidazolam is an adjuvant drug.we should maintain the CPOT≤2 and RASS 0～2,if lidocaine is already used up to 400mg or the pumping rate of remifentanil is already 7.5μg/kg·h,then we should use midazolam 3mg, intravenous injection slowly. | Drug | Lidocaine, Remifentanil, Remifentanil+Lidocaine |
Primary outcome
vital signs change
Time frame: baseline, intraoperative and 10mins after operation
heart rate, respiration rate
vital signs change
Time frame: baseline, intraoperative and 10mins after operation
respiration rate
vital signs change
Time frame: baseline, intraoperative and 10mins after operation
blood oxygen saturation of artery blood of finger(SpO2)
vital signs change
Time frame: baseline, intraoperative and 10mins after operation
mean blood pressure
vital signs change
Time frame: baseline, intraoperative and 10mins after operation
Critical-Care Observation Tool(CPOT)
vital signs change
Time frame: baseline, intraoperative and 10mins after operation
Richmond Agitation-Sedation Scale(RASS)
1 secondary outcome
number of adverse reaction
Time frame: baseline,intraoperative,10mins after operation,30mins after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Results publication: PubMed 9291773Evane TN, Park GR. Remifentanil in the critically ill. Anaesthesia. 1997 Aug;52(8):800-1. No abstract available.
- Results publication: PubMed 11573581Soltesz S, Biedler A, Silomon M, Schopflin I, Molter GP. Recovery after remifentanil and sufentanil for analgesia and sedation of mechanically ventilated patients after trauma or major surgery. Br J Anaesth. 2001 Jun;86(6):763-8. doi: 10.1093/bja/86.6.763.
- Results publication: PubMed 10525595Wilhelm W, Dorscheid E, Schlaich N, Niederprum P, Deller D. [The use of remifentanil in critically ill patients. Clinical findings and early experience]. Anaesthesist. 1999 Sep;48(9):625-9. doi: 10.1007/s001010050762. German.
- Results publication: PubMed 18495056Wilhelm W, Kreuer S. The place for short-acting opioids: special emphasis on remifentanil. Crit Care. 2008;12 Suppl 3(Suppl 3):S5. doi: 10.1186/cc6152. Epub 2008 May 14.
- Results publication: PubMed 20237760Casey E, Lane A, Kuriakose D, McGeary S, Hayes N, Phelan D, Buggy D. Bolus remifentanil for chest drain removal in ICU: a randomized double-blind comparison of three modes of analgesia in post-cardiac surgical patients. Intensive Care Med. 2010 Aug;36(8):1380-5. doi: 10.1007/s00134-010-1836-2. Epub 2010 Mar 18.
- Results publication: PubMed 23052952Chalumeau-Lemoine L, Stoclin A, Billard V, Laplanche A, Raynard B, Blot F. Flexible fiberoptic bronchoscopy and remifentanil target-controlled infusion in ICU: a preliminary study. Intensive Care Med. 2013 Jan;39(1):53-8. doi: 10.1007/s00134-012-2697-7. Epub 2012 Sep 28.
- Results publication: PubMed 21040558Al MJ, Hakkaart L, Tan SS, Bakker J. Cost-consequence analysis of remifentanil-based analgo-sedation vs. conventional analgesia and sedation for patients on mechanical ventilation in the Netherlands. Crit Care. 2010;14(6):R195. doi: 10.1186/cc9313. Epub 2010 Nov 1.
- Results publication: PubMed 21971434Futier E, Chanques G, Cayot Constantin S, Vernis L, Barres A, Guerin R, Chartier C, Perbet S, Petit A, Jabaudon M, Bazin JE, Constantin JM. Influence of opioid choice on mechanical ventilation duration and ICU length of stay. Minerva Anestesiol. 2012 Jan;78(1):46-53. Epub 2011 Nov 5.
- Results publication: PubMed 16526829Battershill AJ, Keating GM. Remifentanil : a review of its analgesic and sedative use in the intensive care unit. Drugs. 2006;66(3):365-85. doi: 10.2165/00003495-200666030-00013.
- Results publication: PubMed 15312228Karabinis A, Mandragos K, Stergiopoulos S, Komnos A, Soukup J, Speelberg B, Kirkham AJ. Safety and efficacy of analgesia-based sedation with remifentanil versus standard hypnotic-based regimens in intensive care unit patients with brain injuries: a randomised, controlled trial [ISRCTN50308308]. Crit Care. 2004 Aug;8(4):R268-80. doi: 10.1186/cc2896. Epub 2004 Jun 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil, Lidocaine and Remifentanil+Lidocaine in people with Critical Illness, run by The First Affiliated Hospital of Zhengzhou University.
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 9 inclusion and 7 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 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vital signs change (time frame: baseline, intraoperative and 10mins after operation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02635802, which also lists 10 linked publications.
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 21 Dec 2015.