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

NCT ID: NCT02674737

Last Updated: 2016-02-04

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start 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 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

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Conditions

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Postoperative Sedation,Gastrectomy, Enhanced Recovery After 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 sedative and analgesic(dexmedetomidine, tramadol and flurbiprofen) are applied to this group of patients.

Group Type EXPERIMENTAL

dexmedetomidine, tramadol and flurbiprofen

Intervention Type DRUG

Tramadol and flurbiprofen

Only routine analgesic(tramadol and flurbiprofen) are applied to 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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Medical Association

NETWORK

Sponsor Role lead

Responsible Party

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Juanhong Shen

Director, PhD, Principal Investigator, Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of General Surgery of Jinling Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Minhua Cheng, M.D.

Role: CONTACT

15951813384

Wenkui Yu, Ph.D.

Role: CONTACT

13701582986

Facility Contacts

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Wenkui Yu, Ph.D.

Role: primary

13701582986

Other Identifiers

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Jinling37ICUCMH

Identifier Type: -

Identifier Source: org_study_id

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