Dezocine for Prevention of Catheter-related Bladder Discomfort

Jian-jun Yang

Status and phase: Completed; Phase 4

Conditions: Catheter Related Bladder Discomfort

Treatments: Drug: Flurbiprofen Axetil; Drug: Dezocine

Study type: Interventional

Funder types: Other

Identifiers

NCT03147066

20170110

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

96 participants in 2 patient groups

Dezocine

Experimental group

Description:

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

Treatment:

Drug: Dezocine

Flurbiprofen axetil

Active Comparator group

Description:

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

Treatment:

Drug: Flurbiprofen Axetil