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

January 28, 2016 updated by: Juanhong Shen, Chinese Medical Association
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Institute of General Surgery of Jinling Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 85 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine,tramadol and flurbiprofen
Both routine analgesic and sedation(dexmedetomidine,tramadol and flurbiprofen) are applied for this group of patients.
Active Comparator: Tramadol and flurbiprofen
Only routine analgesic(Tramadol and flurbiprofen) is applied for this group of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: 1-3d after abdominal surgeries
assessed by Prince Henry Pain Scale by investigators at 8:00 am after surgeries until discharge from ICU
1-3d after abdominal surgeries
recovery of gastrointestinal function
Time Frame: from admission to 30 days after abdominal surgeries
assessed by time to first defecation
from admission to 30 days after abdominal surgeries
white blood cell count(10^9 /L)
Time Frame: 1-3d after abdominal surgeries
evaluation of postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after surgeries
1-3d after abdominal surgeries
C-reactive protein(mg/L)
Time Frame: 1-3d after abdominal surgeries
evaluation of postoperative inflammatory response, blood sample collected at 6:00am for 1-3d after surgeries
1-3d after abdominal surgeries

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of time within target sedation range
Time Frame: 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
1-3d after abdominal surgeries
risk of hypotension requiring interventions
Time Frame: 1-3d after abdominal surgeries
systolic blood pressure <80 mmHg or/and diastolic blood pressure <50 mmHg is considered hypotension
1-3d after abdominal surgeries
risk of bradycardia requiring interventions
Time Frame: 1-3d after abdominal surgeries
heart rate <40/min is considered bradycardia
1-3d after abdominal surgeries
use of opioids and use of benzodiazepins
Time Frame: 1-3d after abdominal surgeries
1-3d after abdominal surgeries

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

January 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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