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

Not Applicable

• Conditions: Catheter Site Discomfort
• Interventions: Other: Preoperative education with image illustrations and/or local tetracaine mucilage

• Registration Number: NCT03199105
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Study Start: 2017-07-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17
• Primary Completion: 2018-10-20
• Study Completion: 2018-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tetracaine	Preoperative education with image illustrations and/or local tetracaine mucilage	-
preoperative education and tetracaine	Preoperative education with image illustrations and/or local tetracaine mucilage	-

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative CRBD	6 hours	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)

Secondary Outcome Measures

Name	Time	Method
The incidence of emergence agitation	6 hours	Using Riker Sedation-Agitation Scale, where 5 to 7 represents agitation and 1 to 3 represents deep sedation
The incidence of postoperative pain	6 hours	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.
The severity of postoperative pain	6 hours	Using a visual analog scale (VAS) score of 0-10, where 0 represents no pain and 10 represents worst imaginable pain.
Incidenc of adverse events	6 hours	Incidenc of adverse events, such asrespiratory depression (SpO2\<90%), deep sedation, and toxicity of tetracaine
The severity of postoperative CRBD	6 hours	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)

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China