Dezocine for Prevention of Catheter-related Bladder Discomfort

NCT ID: NCT03147066

Last Updated: 2017-10-31

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

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2017-10-30

Brief Summary

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This study evaluates the efficacy of dezocine in preventing the catheter-related bladder discomfort (CRBD) in a postanesthesia care unit (PACU).

Detailed Description

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Thirty min before the end of the surgery, patients were randomly assigned to one of the two group to receive intravenous dezocine 0.1 mg/kg (Group D, n=48) or flurbiprofen axetil 1 mg/kg (Group F, n=48) . The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe.

Conditions

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Catheter Related Bladder Discomfort

Keywords

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Dezocine CRBD General anesthesia Urinary catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dezocine

0.1 mg/kg of intravenous dezocine 30 min before the end of surgery

Group Type EXPERIMENTAL

Dezocine

Intervention Type DRUG

Dezocine (0.1 mg/kg)will be infused during surgery

Flurbiprofen axetil

1 mg/kg of intravenous flurbiprofen axetil 30 min before the end of surgery

Group Type ACTIVE_COMPARATOR

Flurbiprofen Axetil

Intervention Type DRUG

Flurbiprofen Axetil (1 mg/kg)will be infused during surgery

Interventions

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Dezocine

Dezocine (0.1 mg/kg)will be infused during surgery

Intervention Type DRUG

Flurbiprofen Axetil

Flurbiprofen Axetil (1 mg/kg)will be infused during surgery

Intervention Type DRUG

Other Intervention Names

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Dalgan

Eligibility Criteria

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Inclusion Criteria

1. Adult (\>/=18)
2. Male or female
3. Patients scheduled for abdominal surgery
4. Undergoing catheterization
5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2

Exclusion Criteria

1. Patient with bladder outflow obstruction
2. Patient with overactive bladder (frequency greater than three times per night or more than eight times per 24 h)
3. Patient with multisystemic diseases (central nervous system, cardiovascular system hepatic, psychiatric, and end-stage renal diseases)
4. Patient with chemical substance abuse
5. Patient with chronic pain
6. Patient with morbid obesity
7. Patient needs for urgent intervention
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jian-jun Yang

OTHER

Sponsor Role lead

Responsible Party

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Jian-jun Yang

Director, Department of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jian-jun Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

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Zhongda Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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20170110

Identifier Type: -

Identifier Source: org_study_id