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NCT Number: NCT03147066

Dezocine for 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).

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Key information

Conditions

Catheter Related Bladder Discomfort

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient with bladder outflow obstruction
  • Patient with overactive bladder (frequency greater than three times per night or more than eight times per 24 h)
  • Patient with multisystemic diseases (central nervous system, cardiovascular system hepatic, psychiatric, and end-stage renal diseases)
  • Patient with chemical substance abuse
  • Patient with chronic pain
  • Patient with morbid obesity
  • Patient needs for urgent intervention

Treatment and study plan

dezocine

Drug

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

Other names: Dalgan

Flurbiprofen Axetil

Drug

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

Primary outcomes

  1. Catheter related bladder discomfort symptoms

    Time frame: at 1 hour after extubatio

    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)

Secondary outcomes

  1. Catheter related bladder discomfort symptoms

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

    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)

  2. Severity of pain at suprapubic area

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

    Pain at suprapubic area will be evaluated using VAS after extubation

  3. Sedation level

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

    The Ramsay Sedation Scale was measured

  4. Incidence of treatment-emergent adverse events

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

    The incidence of nausea, vomiting, hypotension, hypertension, bradycardia,respiratory depression after extubation, and excessive sedation were also recorded

Sponsors and collaborators

Lead sponsor

Jian-jun Yang

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 10, 2017
Registry last updated
Oct 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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