Dezocine for Prevention of Catheter-related Bladder Discomfort

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

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

Study Overview

• Status: Completed
• Conditions: Catheter Related Bladder Discomfort
• Intervention / Treatment: Drug: Dezocine; Drug: Flurbiprofen Axetil

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dezocine; 0.1 mg/kg of intravenous dezocine 30 min before the end of surgery	Drug: Dezocine; Dezocine (0.1 mg/kg）will be infused during surgery; Other Names: Dalgan
Active Comparator: Flurbiprofen axetil; 1 mg/kg of intravenous flurbiprofen axetil 30 min before the end of surgery	Drug: Flurbiprofen Axetil; Flurbiprofen Axetil (1 mg/kg）will be infused during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Sedation level	The Ramsay Sedation Scale was measured	at 0, 1, 2, and 6 hours after extubation
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

Collaborators and Investigators

• Sponsor: Jian-jun Yang
• Investigators: Principal Investigator: Jian-jun Yang, PhD, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): October 30, 2017

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 10, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Urinary catheter; General anesthesia; Dezocine; CRBD
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Flurbiprofen; Flurbiprofen axetil; Dezocine
• Other Study ID Numbers: 20170110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No