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

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ClinicalTrials.gov Identifier: NCT03199105
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Chunling Jiang, 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.

Condition or disease Intervention/treatment Phase
Catheter Site Discomfort Other: Preoperative education with image illustrations and/or local tetracaine mucilage Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2017
Estimated Primary Completion Date : October 20, 2018
Estimated Study Completion Date : October 20, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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.

  4. 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.

  5. Incidenc of adverse events [ Time Frame: 6 hours ]
    Incidenc of adverse events, such asrespiratory depression (SpO2<90%), deep sedation, and toxicity of tetracaine



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199105


Locations
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China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Chunling Jiang, Doctor    18980601096    jiang_chunling@yahoo.com   
Sponsors and Collaborators
West China Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chunling Jiang, Professor, West China Hospital
ClinicalTrials.gov Identifier: NCT03199105     History of Changes
Other Study ID Numbers: 2014-159
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents