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

Not Applicable

Completed

• Conditions: Postoperative Sedation, Abdominal Surgery
• Interventions: Drug: Dexmedetomidine, tramadol and flurbiprofen; Drug: tramadol and flurbiprofen

• Registration Number: NCT02670954
• Lead Sponsor: Chinese Medical Association

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2015-12
• Status Verified: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-28
• Last Update Submitted: 2016-01-28
• Study First Posted: 2016-02-02
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

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