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

• Sponsor: West China Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03199105
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.6
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter Site Discomfort	Other: Preoperative education with image illustrations and/or local tetracaine mucilage	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 1, 2017
• Anticipated Primary Completion Date: Oct 20, 2018
• Anticipated Study Completion Date: Oct 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: preoperative education and tetracaine	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.
Experimental: tetracaine	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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

3. 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.

4. 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.

5. Incidenc of adverse events [6 hours]

   Incidenc of adverse events, such asrespiratory depression (SpO2<90%), deep sedation, and toxicity of tetracaine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• West China Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chunling Jiang, Professor, West China Hospital
• ClinicalTrials.gov Identifier: NCT03199105
• Other Study ID Numbers: 2014-159
• First Posted: Jun 26, 2017
• Last Update Posted: Aug 17, 2018
• Last Verified: Jun 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tetracaine

Study Results

No Results Posted as of Aug 17, 2018