Patient-Controlled Analgesia
Conditions
Keywords
Dexmedetomidine, Dezocine, Flubiprofen, Analgesia, Colorectal Surgery
Brief 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.
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.
Interventions
DRUGDezocine
Dezocine 0.01mg/kg/h intravenous administration during the first two days after surgery.
DRUGFlubiprofen
Flubiprofen 0.5mg/kg/h intravenous administration during the first two days after surgery.
DRUGDexmedetomidine
Dexmedetomidine 0.1μg/kg/h intravenous administration during the first two days after surgery.
Sponsors
Weifeng Tu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesiologists(ASA) Ⅰ-Ⅱ patient undergoing open colorectal surgery 2. Written informed consent from the patient or the relatives of the participating patient. 3. BMI:18～30kg/m2
Exclusion criteria
1. Mental illness or cannot communicate.; 2. A second operation during the study; 3. Slow-type arrhythmias or hypotension; 4. Lung infection or sleep apnea syndrome; 5. Renal failure; 6. Alcohol or drug abuse; 7. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug; 8. Long-term use of analgesics,sedatives or non steroidal anti-inflammatory drugs history;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dezocine consumption by patient-controlled analgesia | At 24 hours after surgery | The total consumption of dezocine during 24 hours after surgery are recorded. |
| Change in pain score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ramsay sedation score | At 0, 2, 4, 8, 24, 48 and 72 hours after surgery | Measure sedation level by using ramsay sedation score |
| The incidence rates of postoperative nausea and vomiting (PONV) | At 24 hours after surgery | Measure whether nausea and vomiting exist and the level of severity. |
Countries
China
Contacts
Primary ContactWeifeng Tu, PhD
Outcome results
None listed