Dezocine for Prevention of Catheter-related Bladder Discomfort

Catheter Related Bladder Discomfort Clinical Trial

Official title:

Efficacy of Dezocine for the Prevention of Catheter-related Bladder Discomfort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147066
• Other study ID #: 20170110
• Status: Completed
• Phase: Phase 4
• First received: May 2, 2017
• Last updated: October 30, 2017
• Start date: September 1, 2017
• Est. completion date: October 30, 2017

Study information

• Verified date: August 2017
• Source: Zhongda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 30, 2017
• Est. primary completion date: October 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter Related Bladder Discomfort

Intervention

Drug:
• Dezocine
Dezocine (0.1 mg/kg)will be infused during surgery
• Flurbiprofen Axetil
Flurbiprofen Axetil (1 mg/kg)will be infused during surgery

Locations

Country	Name	City	State
China	Zhongda Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jian-jun Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter related bladder discomfort symptoms	CRBD will be evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses)	at 1 hour after extubatio
Secondary	Catheter related bladder discomfort symptoms	CRBD will be evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses)	at 0, 1, 2, and 6 hours after extubation
Secondary	Severity of pain at suprapubic area	Pain at suprapubic area will be evaluated using VAS after extubation	at 0, 1, 2, and 6 hours after extubation
Secondary	Sedation level	The Ramsay Sedation Scale was measured	at 0, 1, 2, and 6 hours after extubation
Secondary	Incidence of treatment-emergent adverse events	The incidence of nausea, vomiting, hypotension, hypertension, bradycardia,respiratory depression after extubation, and excessive sedation were also recorded	at 0, 1, 2, and 6 hours after extubation