Clinical trial NCT03199105: Preoperative Education With Image Illustrations Enhances Effect of Tetracaine Mucilage in Alleviating Postoperative CRBD
Official title: Preoperative Education With Image Illustrations Enhances the Effect of Tetracaine Mucilage in Alleviating Postoperative Catheter-related Bladder Discomfort: a Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Catheter Site Discomfort
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Catheter-related bladder discomfort (CRBD) is not uncommon in male patients under general anesthesia, and it may cause patient agitation and exacerbated postoperative pain. In this study, the investigators will enroll male patients undergoing elective colonal and rectal surgery with surgical duration of at least 2 h, requiring catheterization of the urinary bladder with urinary catheterization after anesthetic induction, and compare preoperative education with image illustrations combined with local tetracaine mucilage vs. local tetracaine mucilage alone in alleviating CRBD during the post-operative period.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 years to 75 years.
2. American Society of Anesthesiologists (ASA) physical status I, II.
3. Undergoing elective noncardiac surgery with urinary catheterization after 4.anesthetic induction under general anesthesia.

5.Duration of surgery more than 2h 6.Glasgow Coma Scale (GCS) score of 15. Ability to communicate.

Exclusion Criteria:

1. History of bladder dysfunction, such as over active bladder (OAB, urinary frequency: more than three times in the night or more than eight times in 24 h).
2. History of bladder outflow obstruction.
3. Neurogenic bladder.
4. Impaired renal function.
5. Coagulopathy.
6. Known allergies to any anesthetic agent.
7. Family history of malignant hyperthermia.
8. Impairment of communication or cognition.
9. Psychopathy.
10. Active participation in another trial where the primary endpoint follow-up is ongoing.
11. Unwillingness or inability to comply with protocol procedures.

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Primary outcomes:
measure: The incidence of postoperative CRBD
timeFrame: 6 hours
Secondary outcomes:
measure: The severity of postoperative CRBD
timeFrame: 6 hours
measure: The incidence of emergence agitation
timeFrame: 6 hours
measure: The incidence of postoperative pain
timeFrame: 6 hours
measure: The severity of postoperative pain
timeFrame: 6 hours
measure: Incidenc of adverse events
timeFrame: 6 hours
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References:
citation: Zhou L, Zhou L, Tian L, Zhu D, Chen Z, Zheng C, Zhou T, Zeng X, Jiang X, Jiang C, Bo L. Preoperative education with image illustrations enhances the effect of tetracaine mucilage in alleviating postoperative catheter-related bladder discomfort: a prospective, randomized, controlled study. BMC Anesthesiol. 2018 Dec 22;18(1):204. doi: 10.1186/s12871-018-0653-y.