RestlessnessPhase 4NCT01517932
Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia
A Phase 4 study testing dexmedetomidine in people with Restlessness and Pain, run by Fang Luo.
Trial summary
Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Restlessness, Pain
- What is being tested?
- dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Dec 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
- undergoing selective thoracotomy
- weight between 45 and 75kg
- operation time 2-4 hours
Who cannot join
- history of neurologic disease
- history of chronic analgesics intake
- history of allergic reactions to the experimental durgs
- history of renal insufficiency
- history of hepatic dysfunction
- history of coagulation disorders
- women in lactation
- participating in other studies
About this study
Official title: Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period
Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression.
In this prospective, randomized, double-blind, placebo-controlled study，we gave dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of dexmedetomidine on stress response and postoperative analgesia in patients undergoing thoracotomy during anesthesia recovery period.
Read the detailed description
Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery
- Conditions
- Restlessness, Pain
- Being tested
- dexmedetomidine, saline placebo
- Medical subject headings
- Psychomotor Agitation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidineDrug
In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.
Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.
Patients in this arm received dexmedetomidine 0.2μg/kg i.v. during 10 minutes 1 hour before the end of surgery
saline placeboDrug
In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.
Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.
Patients in this arm received saline placebo of the same volume i.v. during 10 minutes 1 hour before the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Group-DEX | Experimental | Patients in this arm received dexmedetomidine 0.2 microgram per kg i.v. during 10 minutes 1 hour before the end of surgery Receives: Drug: dexmedetomidine |
| Group-PLB | Placebo comparator | Patients in this arm received saline placebo 0.05 ml per kilogram i.v. during 10 minutes 1 hour before the end of surgery Receives: Drug: saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence agitation
Emergence agitation was assessed by the highest restlessness score（RS）during 0-3 postoperative hours
Measured: during 0-3 postoperative hours
Secondary outcomes (6)
Postoperative pain at rest
The patients were instructed to give the number that represented the pain level at rest by using visual analogue scale（VAS）and prince-henry score
Measured: At 1,3 postoperative hours
dosage Dosage of analgesics
Measured: during 3 postoperative hours
Recovery time
Measured: At the moment of the eyes opend when calling the names
Postoperative sedation
It was assessed by Ramsay Sedation Score(RSS)
Measured: at 0,1,3 postoperative hours
Extubation time
Measured: at the moment of extubation
Breathing recovery time
Measured: when autonomous respiration recovered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RestlessnessStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fang Luo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fang Luo, Huazhong University of Science and Technology
- Investigators
- Fang Luo, MD.PhD, Study director, Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517932
- Sponsor's protocol ID
- TJMU-A-201106
- Status last verified
- Mar 2013
- First submitted
- 22 Jan 2012
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Stress Response and Postoperative Analgesia in Patients Undergoing Thoracotomy During Anesthesia Recovery Period
- ClinicalTrials.gov ID
- NCT01517932
- Acronym / sponsor ID
- TJMU-A-201106
- Conditions
- Restlessness, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fang LuoUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Jan 2012 (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.
Dexmedetomidine is a highly selective α2 adrenoreceptor agonist approved by the US FDA for short-term postoperative sedation and analgesia.It can also reduce the stress response without respiratory depression.
In this prospective, randomized, double-blind, placebo-controlled study，we gave dexmedetomidine or saline placebo 1h before operations were over and assessed the effects of dexmedetomidine on stress response and postoperative analgesia in patients undergoing thoracotomy during anesthesia recovery period.
Detailed description
Dexmedetomidine can significantly reduce the emergence agitation and postoperative pain in patients who received chest surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-DEX | Experimental | Drug: dexmedetomidinePatients in this arm received dexmedetomidine 0.2 microgram per kg i.v. during 10 minutes 1 hour before the end of surgery |
| Group-PLB | Placebo comparator | Drug: saline placeboPatients in this arm received saline placebo 0.05 ml per kilogram i.v. during 10 minutes 1 hour before the end of surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anaesthesiologists Physical Status (ASA-PS) I or II
- undergoing selective thoracotomy
- weight between 45 and 75kg
- operation time 2-4 hours
Key exclusion criteria (8 listed)
- history of neurologic disease
- history of chronic analgesics intake
- history of allergic reactions to the experimental durgs
- history of renal insufficiency
- history of hepatic dysfunction
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 |
|---|---|---|
| dexmedetomidineIn this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction. Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46. Patients in this arm received dexmedetomidine 0.2μg/kg i.v. during 10 minutes 1 hour before the end of surgery | Drug | Group-DEX |
| saline placeboIn this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction. Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46. Patients in this arm received saline placebo of the same volume i.v. during 10 minutes 1 hour before the end of surgery | Drug | Group-PLB |
Primary outcome
Emergence agitation
Time frame: during 0-3 postoperative hours
Emergence agitation was assessed by the highest restlessness score（RS）during 0-3 postoperative hours
6 secondary outcomes
Postoperative pain at rest
Time frame: At 1,3 postoperative hours
dosage Dosage of analgesics
Time frame: during 3 postoperative hours
Recovery time
Time frame: At the moment of the eyes opend when calling the names
Postoperative sedation
Time frame: at 0,1,3 postoperative hours
Extubation time
Time frame: at the moment of extubation
Breathing recovery time
Time frame: when autonomous respiration recovered
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
Related trials for Restlessness
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 2/3
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Agitation Associated With Alzheimer's Disease Dementia
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
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.
Fang Luo, MD.PhD study director
Department of Anaesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan 430030, China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine in people with Restlessness and Pain, run by Fang Luo.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 20 Mar 2013. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Emergence agitation (time frame: during 0-3 postoperative 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 20 Mar 2013.