Postoperative Sedation, Abdominal Surgery
Conditions
Brief summary
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.
Interventions
Sponsors
Chinese Medical Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C-reactive protein(mg/L) | 1-3d after abdominal surgeries | evaluation of postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after surgeries |
| postoperative pain | 1-3d after abdominal surgeries | assessed by Prince Henry Pain Scale by investigators at 8:00 am after surgeries until discharge from ICU |
| recovery of gastrointestinal function | from admission to 30 days after abdominal surgeries | assessed by time to first defecation |
| white blood cell count(10^9 /L) | 1-3d after abdominal surgeries | evaluation of postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after surgeries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of time within target sedation range | 1-3d after abdominal surgeries | assessed by Richmond Agitation-Sedation Scale by investigators at 8:00 am after surgeries until discharge from ICU, target range is -2 to +1 |
| risk of hypotension requiring interventions | 1-3d after abdominal surgeries | systolic blood pressure \<80 mmHg or/and diastolic blood pressure \<50 mmHg is considered hypotension |
| risk of bradycardia requiring interventions | 1-3d after abdominal surgeries | heart rate \<40/min is considered bradycardia |
| use of opioids and use of benzodiazepins | 1-3d after abdominal surgeries | — |
Countries
China
Outcome results
None listed