Patient-Controlled AnalgesiaPhase 4NCT03014713
Effect of Dexmedetomidine for Postoperative Intravenous Patient Controlled Analgesia
A Phase 4 study testing Dezocine, Flubiprofen and Dexmedetomidine in people with Patient-Controlled Analgesia, run by Weifeng Tu at 1 site in China.
Trial summary
The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, combined with dezocine and flubiprofen, used in intravenous Patient-Controlled Analgesia (PCA) after open colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patient-Controlled Analgesia
- What is being tested?
- Dezocine, Flubiprofen and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2017
- 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 Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing open colorectal surgery
- Written informed consent from the patient or the relatives of the participating patient.
- BMI:18～30kg/m2
Who cannot join
- Mental illness or cannot communicate.;
- A second operation during the study;
- Slow-type arrhythmias or hypotension;
- Lung infection or sleep apnea syndrome;
- Renal failure;
- Alcohol or drug abuse;
- Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug;
- Long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010
Weifeng Tu, +8613922116606, wftuyx02@163.com
Chuangbo Xie, +8615521118558, xiechuangbo@126.com
About this study
Official title: Effect of Dexmedetomidine Combined With Dezocine and Flubiprofen for Postoperative Intravenous Patient Controlled Analgesia After Colorectal Surgery
The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, combined with dezocine and flubiprofen, used in intravenous Patient-Controlled Analgesia (PCA) after open colorectal surgery.
Read the detailed description
Dexmedetomidine is a selective alpha-2 adrenoceptor agonist, which has been demonstrated to have anaesthetic, sedative and analgesic-sparing effects. Besides, Dexmedetomidine has been reported to cause sedative effects and reduce opioid requirements in the perioperative period. Many studies had been conducted to reduce the side effect of opioid analgesic. The current trend of reducing opioid analgesic side effect is direct combination of other drugs in PCA. The advantages of this method are convenient in clinical use and preventive for side effects.
In this study, 50 patients who is undergoing elective colorectal surgery will be randomly allocated into two groups (Control group and Dexmedetomidine group). Patients in both groups will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery unit (PACU) after surgery.
The PCA protocol of Control group is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min. The PCA protocol of Dexmedetomidine group is dezocine 0.6mg/kg, flubiprofen 3mg/k and dexmedetomidine 6μg/kg diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min.
- Conditions
- Patient-Controlled Analgesia
- Being tested
- Dezocine, Flubiprofen, Dexmedetomidine
- Keywords
- Dexmedetomidine, Dezocine, Flubiprofen, Analgesia, Colorectal Surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DezocineDrug
Dezocine 0.01mg/kg/h intravenous administration during the first two days after surgery.
FlubiprofenDrug
Flubiprofen 0.5mg/kg/h intravenous administration during the first two days after surgery.
DexmedetomidineDrug
Dexmedetomidine 0.1μg/kg/h intravenous administration during the first two days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h. Receives: Drug: Dezocine; Drug: Flubiprofen |
| Dexmedetomidine Group | Experimental | Patients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h,dexmedetomidine 0.1μg/kg/h. Receives: Drug: Dezocine; Drug: Flubiprofen; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dezocine consumption by patient-controlled analgesia
The total consumption of dezocine during 24 hours after surgery are recorded.
Measured: At 24 hours after surgery
Change in pain score
Pain scores at rest and movement are evaluated with a numeric rating scale (NRS).
Measured: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
Secondary outcomes (2)
Change in ramsay sedation score
Measure sedation level by using ramsay sedation score
Measured: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
The incidence rates of postoperative nausea and vomiting (PONV)
Measure whether nausea and vomiting exist and the level of severity.
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patient-Controlled 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weifeng Tu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Weifeng Tu, Guangzhou General Hospital of Guangzhou Military Command
- Investigators
- Weifeng Tu, PhD, Principal investigator, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014713
- Sponsor's protocol ID
- Dexmedetomidine PCA
- Status last verified
- Jan 2017
- First submitted
- 3 Jan 2017
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bellon M, Le Bot A, Michelet D, Hilly J, Maesani M, Brasher C, Dahmani S. Efficacy of Intraoperative Dexmedetomidine Compared with Placebo for Postoperative Pain Management: A Meta-Analysis of Published Studies. Pain Ther. 2016 Jun;5(1):63-80. doi: 10.1007/s40122-016-0045-2. Epub 2016 Feb 10.
PubMed 26861737Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Hysterectomy: a Double-Blind, Randomized Clinical Trial. Sci Rep. 2016 Feb 23;6:21514. doi: 10.1038/srep21514.
PubMed 26903197Jessen Lundorf L, Korvenius Nedergaard H, Moller AM. Perioperative dexmedetomidine for acute pain after abdominal surgery in adults. Cochrane Database Syst Rev. 2016 Feb 18;2(2):CD010358. doi: 10.1002/14651858.CD010358.pub2.
PubMed 26889627
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine Combined With Dezocine and Flubiprofen for Postoperative Intravenous Patient Controlled Analgesia After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03014713
- Acronym / sponsor ID
- Dexmedetomidine PCA
- Conditions
- Patient-Controlled Analgesia
- Keywords
- Dexmedetomidine, Dezocine, Flubiprofen, Analgesia, Colorectal Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Weifeng TuUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 9 Jan 2017 (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.
The purpose of this study is to explore the effectiveness of dexmedetomidine as an adjunctive analgesic, combined with dezocine and flubiprofen, used in intravenous Patient-Controlled Analgesia (PCA) after open colorectal surgery.
Detailed description
Dexmedetomidine is a selective alpha-2 adrenoceptor agonist, which has been demonstrated to have anaesthetic, sedative and analgesic-sparing effects. Besides, Dexmedetomidine has been reported to cause sedative effects and reduce opioid requirements in the perioperative period. Many studies had been conducted to reduce the side effect of opioid analgesic. The current trend of reducing opioid analgesic side effect is direct combination of other drugs in PCA. The advantages of this method are convenient in clinical use and preventive for side effects.
In this study, 50 patients who is undergoing elective colorectal surgery will be randomly allocated into two groups (Control group and Dexmedetomidine group). Patients in both groups will be given a patient-controlled analgesia (PCA) pump in post anesthetic recovery unit (PACU) after surgery.
The PCA protocol of Control group is dezocine 0.6mg/kg, flubiprofen 3mg/kg, diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min. The PCA protocol of Dexmedetomidine group is dezocine 0.6mg/kg, flubiprofen 3mg/k and dexmedetomidine 6μg/kg diluted into 120ml and administer at a background infusion of 2ml/h, and a bolus of 2ml, with a lock-out of 15min.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: Dezocine, Drug: FlubiprofenPatients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h. |
| Dexmedetomidine Group | Experimental | Drug: Dezocine, Drug: Flubiprofen, Drug: DexmedetomidinePatients in this group receive intravenous Patient-Controlled Analgesia(PCA) pump after surgery.The intravenous PCA protocol is dezocine 0.01mg/kg/h,flubiprofen 0.05mg/kg/h,dexmedetomidine 0.1μg/kg/h. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing open colorectal surgery
- Written informed consent from the patient or the relatives of the participating patient.
- BMI:18～30kg/m2
Key exclusion criteria (8 listed)
- Mental illness or cannot communicate.;
- A second operation during the study;
- Slow-type arrhythmias or hypotension;
- Lung infection or sleep apnea syndrome;
- Renal failure;
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 |
|---|---|---|
| DezocineDezocine 0.01mg/kg/h intravenous administration during the first two days after surgery. | Drug | Control Group, Dexmedetomidine Group |
| FlubiprofenFlubiprofen 0.5mg/kg/h intravenous administration during the first two days after surgery. | Drug | Control Group, Dexmedetomidine Group |
| DexmedetomidineDexmedetomidine 0.1μg/kg/h intravenous administration during the first two days after surgery. | Drug | Dexmedetomidine Group |
Primary outcome
Dezocine consumption by patient-controlled analgesia
Time frame: At 24 hours after surgery
The total consumption of dezocine during 24 hours after surgery are recorded.
Change in pain score
Time frame: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
Pain scores at rest and movement are evaluated with a numeric rating scale (NRS).
2 secondary outcomes
Change in ramsay sedation score
Time frame: At 0, 2, 4, 8, 24, 48 and 72 hours after surgery
The incidence rates of postoperative nausea and vomiting (PONV)
Time frame: At 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Background: PubMed 26861737Bellon M, Le Bot A, Michelet D, Hilly J, Maesani M, Brasher C, Dahmani S. Efficacy of Intraoperative Dexmedetomidine Compared with Placebo for Postoperative Pain Management: A Meta-Analysis of Published Studies. Pain Ther. 2016 Jun;5(1):63-80. doi: 10.1007/s40122-016-0045-2. Epub 2016 Feb 10.
- Background: PubMed 26903197Ge DJ, Qi B, Tang G, Li JY. Intraoperative Dexmedetomidine Promotes Postoperative Analgesia and Recovery in Patients after Abdominal Hysterectomy: a Double-Blind, Randomized Clinical Trial. Sci Rep. 2016 Feb 23;6:21514. doi: 10.1038/srep21514.
- Background: PubMed 26889627Jessen Lundorf L, Korvenius Nedergaard H, Moller AM. Perioperative dexmedetomidine for acute pain after abdominal surgery in adults. Cochrane Database Syst Rev. 2016 Feb 18;2(2):CD010358. doi: 10.1002/14651858.CD010358.pub2.
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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.
Weifeng Tu, PhD principal investigator
Guangzhou General Hospital of Guangzhou Military Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dezocine, Flubiprofen and Dexmedetomidine in people with Patient-Controlled Analgesia, run by Weifeng Tu at 1 site 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 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: status not confirmed, as of the sponsor's last update on 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Contact Weifeng Tu, PhD (+8613922116606, wftuyx02@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dezocine consumption by patient-controlled analgesia (time frame: At 24 hours after surgery). The study lists 2 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 NCT03014713, which also lists 3 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 9 Jan 2017.