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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dezocine | Drug | Dezocine 0.01mg/kg/h intravenous administration during the first two days after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dezocine consumption by patient-controlled analgesia | The total consumption of dezocine during 24 hours after surgery are recorded. | At 24 hours after surgery |
| Change in pain score | Pain scores at rest and movement are evaluated with a numeric rating scale (NRS). | At 0, 2, 4, 8, 24, 48 and 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ramsay sedation score | Measure sedation level by using ramsay sedation score | At 0, 2, 4, 8, 24, 48 and 72 hours after surgery |
| The incidence rates of postoperative nausea and vomiting (PONV) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weifeng Tu, PhD | Contact | +8613922116606 | wftuyx02@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weifeng Tu, PhD | Guangzhou General Hospital of Guangzhou Military Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou General Hospital of Guangzhou Military Command | Recruiting | Guangzhou | Guangdong | 510010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26861737 | Background | 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. | |
| 26903197 | Background |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C010827 | dezocine |
| D005480 | Flurbiprofen |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Flubiprofen | Drug | Flubiprofen 0.5mg/kg/h intravenous administration during the first two days after surgery. |
|
| Dexmedetomidine | Drug | Dexmedetomidine 0.1μg/kg/h intravenous administration during the first two days after surgery. |
|
Measure whether nausea and vomiting exist and the level of severity.
| At 24 hours after surgery |
| Ge 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. |
| 26889627 | Background | Jessen 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001713 |
| Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |