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

NCT ID: NCT03199105

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-10-20

Brief Summary

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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

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Conditions

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Catheter Site Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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preoperative education and tetracaine

Group Type EXPERIMENTAL

Preoperative education with image illustrations and/or local tetracaine mucilage

Intervention Type OTHER

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

tetracaine

Group Type EXPERIMENTAL

Preoperative education with image illustrations and/or local tetracaine mucilage

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chunling Jiang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Chunling Jiang, Doctor

Role: primary

18980601096

References

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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.

Reference Type DERIVED
PMID: 30579342 (View on PubMed)

Other Identifiers

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2014-159

Identifier Type: -

Identifier Source: org_study_id

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