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