Evaluation of the Effect of Appropriate Sedation for Patients After Gastrectomy: 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 gastrectomy. Prospective randomised controlled study was conducted from October 2015 and December 2015 among patients after gastrectomy. The investigators are going to 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 follow up for 3 days.

Conditions
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Postoperative Sedation,Gastrectomy, Enhanced Recovery After 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: 18-85 years old underwent gastrectomy 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: 18 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 sedative and analgesic(dexmedetomidine, tramadol and flurbiprofen) are applied to this group of patients. | Drug: dexmedetomidine, tramadol and flurbiprofen<br> <br> |
| Active Comparator: Tramadol and flurbiprofen<br>Only routine analgesic(tramadol and flurbiprofen) are applied to 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 | assessed by Prince Henry Pain Scale by investigators at 8:00 am after surgeries until discharge from ICU | 1-3d after gastrectomy | 
| recovery of gastrointestinal function assessed by time to first defecation after surgery | assessed by time to first defecation after surgery | 30 days after gastrectomy | 
| white blood cell count (10^9/L) | evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy | 1-3d after gastrectomy | 
| C-reactive protein (mg/L) | evaluate postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after gastrectomy | 1-3d after gastrectomy | 

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, the target range is -2 to +1 | 1-3d after gastrectomy | 
| risk of bradycardia requiring interventions | heart rate <40/min is considered bradycardia | 1-3d after gastrectomy | 
| risk of hypotension requiring interventions | systolic blood pressure <80 mmHg or/and diastolic blood pressure <50 mmHg is considered hypotension | 1-3d after gastrectomy | 
| use of opioids and use of benzodiazepins |  | 1-3d after gastrectomy |