Dezocine for Prevention of Catheter-related Bladder Discomfort

Jian-jun Yang96 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Catheter Related Bladder Discomfort

Interventions

DezocineDRUG

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

Flurbiprofen AxetilDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Zhongda Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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)

Time frame: at 1 hour after extubatio

Secondary Outcomes

Catheter related bladder discomfort symptoms

Time frame: 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

Time frame: at 0, 1, 2, and 6 hours after extubation

Sedation level

The Ramsay Sedation Scale was measured

Time frame: 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

Time frame: at 0, 1, 2, and 6 hours after extubation

Data from ClinicalTrials.gov

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