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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Sedation, Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine,tramadol and flurbiprofen

Both routine analgesic and sedation(dexmedetomidine,tramadol and flurbiprofen) are applied for this group of patients.

Group Type EXPERIMENTAL

Dexmedetomidine, tramadol and flurbiprofen

Intervention Type DRUG

Tramadol and flurbiprofen

Only routine analgesic(Tramadol and flurbiprofen) is applied for this group of patients.

Group Type ACTIVE_COMPARATOR

tramadol and flurbiprofen

Intervention Type DRUG

Interventions

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Dexmedetomidine, tramadol and flurbiprofen

Intervention Type DRUG

tramadol and flurbiprofen

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No