Evaluation of the Effect of Appropriate Sedation for Patients After Abdominal Surgeries : A Prospective Randomised Controlled Study

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of appropriate postoperative sedation with dexmedetomidine for patients after abdominal surgeries.Prospective randomised controlled study was conducted among patients after abdominal surgeries began in October 2015.The investigators enroll patients who received abdominal surgeries. One group receive sedative along with analgesic and the other group analgesic only for the other group on the first 24 hours after surgeries and will follow up for 3 days.

Conditions
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Postoperative Sedation, Abdominal Surgery

Intervention / Treatment
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* Drug: Dexmedetomidine, tramadol and flurbiprofen
* Drug: tramadol and flurbiprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 16-85 years old underwent abdominal surgeries including enterectomy, gastrectomy, hepatectomy and pancreatectomy in the hospital and operation duration lasted at least 2 hours. Exclusion Criteria take part in other clinical trials quinolone antibiotics intake 4 weeks prior to or within the study NSAIDS intake within one month history of peptic ulcer respiratory insufficiency renal insufficiency acute hepatitis or severe liver disease (Child-Pugh class C) pregnancy or lactation abnormal ECG with clinical significance uncontrolled hypotension bleeding tendency or hematological diseases untreated mechanical intestinal obstruction unable to express or any kind of mental disease.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine,tramadol and flurbiprofen<br>Both routine analgesic and sedation(dexmedetomidine,tramadol and flurbiprofen) are applied for this group of patients. | Drug: Dexmedetomidine, tramadol and flurbiprofen<br> <br> |
| Active Comparator: Tramadol and flurbiprofen<br>Only routine analgesic(Tramadol and flurbiprofen) is applied for this group of patients. | Drug: tramadol and flurbiprofen<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | assessed by Prince Henry Pain Scale by investigators at 8:00 am after surgeries until discharge from ICU | 1-3d after abdominal surgeries | 
| recovery of gastrointestinal function | assessed by time to first defecation | from admission to 30 days after abdominal surgeries | 
| white blood cell count(10^9 /L) | evaluation of postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after surgeries | 1-3d after abdominal surgeries | 
| C-reactive protein(mg/L) | evaluation of postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after surgeries | 1-3d after abdominal surgeries | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of time within target sedation range | assessed by Richmond Agitation-Sedation Scale by investigators at 8:00 am after surgeries until discharge from ICU, target range is -2 to +1 | 1-3d after abdominal surgeries | 
| risk of hypotension requiring interventions | systolic blood pressure <80 mmHg or/and diastolic blood pressure <50 mmHg is considered hypotension | 1-3d after abdominal surgeries | 
| risk of bradycardia requiring interventions | heart rate <40/min is considered bradycardia | 1-3d after abdominal surgeries | 
| use of opioids and use of benzodiazepins |  | 1-3d after abdominal surgeries |