- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03199105
Preoperative Education With Image Illustrations Enhances Effect of Tetracaine Mucilage in Alleviating Postoperative CRBD
August 15, 2018 updated by: Chunling Jiang, West China Hospital
Preoperative Education With Image Illustrations Enhances the Effect of Tetracaine Mucilage in Alleviating Postoperative Catheter-related Bladder Discomfort: a Prospective, Randomized, Controlled Study
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- West China Hospital
-
Contact:
- Chunling Jiang, Doctor
- Phone Number: 18980601096
- Email: jiang_chunling@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Patients aged 18 years to 75 years.
- American Society of Anesthesiologists (ASA) physical status I, II.
- 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:
- 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).
- History of bladder outflow obstruction.
- Neurogenic bladder.
- Impaired renal function.
- Coagulopathy.
- Known allergies to any anesthetic agent.
- Family history of malignant hyperthermia.
- Impairment of communication or cognition.
- Psychopathy.
- Active participation in another trial where the primary endpoint follow-up is ongoing.
Unwillingness or inability to comply with protocol procedures.
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: preoperative education and tetracaine
|
The patients were given preoperative education with image illustrations and/or local tetracaine mucilage to alleviate CRBD during the post-operative period.
|
Experimental: tetracaine
|
The patients were given preoperative education with image illustrations and/or local tetracaine mucilage to alleviate CRBD during the post-operative period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of postoperative CRBD
Time Frame: 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)
|
6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The severity of postoperative CRBD
Time Frame: 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)
|
6 hours
|
The incidence of emergence agitation
Time Frame: 6 hours
|
Using Riker Sedation-Agitation Scale, where 5 to 7 represents agitation and 1 to 3 represents deep sedation
|
6 hours
|
The incidence of postoperative pain
Time Frame: 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.
|
6 hours
|
The severity of postoperative pain
Time Frame: 6 hours
|
Using a visual analog scale (VAS) score of 0-10, where 0 represents no pain and 10 represents worst imaginable pain.
|
6 hours
|
Incidenc of adverse events
Time Frame: 6 hours
|
Incidenc of adverse events, such asrespiratory depression (SpO2<90%), deep sedation, and toxicity of tetracaine
|
6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2017
Primary Completion (Anticipated)
October 20, 2018
Study Completion (Anticipated)
October 20, 2018
Study Registration Dates
First Submitted
June 22, 2017
First Submitted That Met QC Criteria
June 22, 2017
First Posted (Actual)
June 26, 2017
Study Record Updates
Last Update Posted (Actual)
August 17, 2018
Last Update Submitted That Met QC Criteria
August 15, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-159
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Catheter Site Discomfort
-
West China HospitalUnknownCatheter Site DiscomfortChina
-
Washington University School of MedicineTerminatedCatheter Site Discomfort | Urethra InjuryUnited States
-
Coloplast A/SCompletedCatheter Site Discomfort | Catheter Site PainDenmark
-
Buddhist Tzu Chi General HospitalNot yet recruitingUrinary Catheter | Catheter-Related Bladder Discomfort
-
Cairo UniversityCompletedCatheter Related Bladder DiscomfortEgypt
-
Pinar ErgenogluCompleted
-
Jian-jun YangCompletedCatheter Related Bladder DiscomfortChina
-
Creighton UniversityUnknownUrinary Catheter Discomfort in Surgical Patients
-
Seoul National University HospitalCompletedNefopam | Catheter-related Bladder DiscomfortKorea, Republic of
-
Saint Savvas Anticancer HospitalUniversity of ThessalyCompletedPregabalin on Catheter Related Bladder DiscomfortGreece