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

Not Applicable

• Conditions: Postoperative Sedation,Gastrectomy, Enhanced Recovery After Surgery
• Interventions: Drug: tramadol and flurbiprofen; Drug: dexmedetomidine, tramadol and flurbiprofen

• Registration Number: NCT02674737
• Lead Sponsor: Chinese Medical Association

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-02-03
• Last Update Submitted: 2016-02-03
• Study First Posted: 2016-02-04
• Last Update Posted: 2016-02-04
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol and flurbiprofen	tramadol and flurbiprofen	Only routine analgesic(tramadol and flurbiprofen) are applied to this group of patients.
Dexmedetomidine,tramadol and flurbiprofen	dexmedetomidine, tramadol and flurbiprofen	Both sedative and analgesic(dexmedetomidine, tramadol and flurbiprofen) are applied to this group of patients.

Primary Outcome Measures

Name	Time	Method
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
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
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of General Surgery of Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China