Preoperative Education With Image Illustrations Enhances Effect of Tetracaine Mucilage in Alleviating Postoperative CRBD

Catheter Site Discomfort Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03199105
• Other study ID #: 2014-159
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: October 20, 2018

Study information

• Verified date: June 2018
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 20, 2018
• Est. primary completion date: October 20, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Catheter Site Discomfort

Intervention

Other:
• Preoperative education with image illustrations and/or local tetracaine mucilage
The patients were given preoperative education with image illustrations and/or local tetracaine mucilage to alleviate CRBD during the post-operative period.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative CRBD	The incidence of postoperative CRBD; CRBD was assessed according to the following scaling system: no CRBD; mild CRBD (complaint about CRBD on questioning only); moderate CRBD (complaint about CRBD without enquiring); and severe CRBD (complaint about CRBD without enquiring, with urinary urgency demonstrated by a spontaneous behavioural response such as flailing limb, verbal responses, or attempt to remove the catheter)	6 hours
Secondary	The severity of postoperative CRBD	The severity of CRBD was assessed according to the following scaling system: no CRBD; mild CRBD (complaint about CRBD on questioning only); moderate CRBD (complaint about CRBD without enquiring); and severe CRBD (complaint about CRBD without enquiring, with urinary urgency demonstrated by a spontaneous behavioural response such as flailing limb, verbal responses, or attempt to remove the catheter)	6 hours
Secondary	The incidence of emergence agitation	Using Riker Sedation-Agitation Scale, where 5 to 7 represents agitation and 1 to 3 represents deep sedation	6 hours
Secondary	The incidence of postoperative pain	The incidence of postoperative pain;Using a visual analog scale (VAS) score of 0-10, where 0 represents no pain and 10 represents worst imaginable pain.	6 hours
Secondary	The severity of postoperative pain	Using a visual analog scale (VAS) score of 0-10, where 0 represents no pain and 10 represents worst imaginable pain.	6 hours
Secondary	Incidenc of adverse events	Incidenc of adverse events, such asrespiratory depression (SpO2<90%), deep sedation, and toxicity of tetracaine	6 hours