NCT03199105

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2018

Completed
Last Updated

August 17, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

June 22, 2017

Last Update Submit

August 15, 2018

Conditions

Catheter Site Discomfort

Outcome Measures

Primary Outcomes (1)

  • The incidence of postoperative CRBD

    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 Outcomes (5)

  • The severity of postoperative CRBD

    6 hours

  • The incidence of emergence agitation

    6 hours

  • The incidence of postoperative pain

    6 hours

  • The severity of postoperative pain

    6 hours

  • Incidenc of adverse events

    6 hours

Study Arms (2)

preoperative education and tetracaine

EXPERIMENTAL
Other: Preoperative education with image illustrations and/or local tetracaine mucilage

tetracaine

EXPERIMENTAL
Other: Preoperative education with image illustrations and/or local tetracaine mucilage

Interventions

Preoperative education with image illustrations and/or local tetracaine mucilageOTHER

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

preoperative education and tetracainetetracaine

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Duration of surgery more than 2h 6.Glasgow Coma Scale (GCS) score of 15. Ability to communicate.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30579342DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2017

First Posted

June 26, 2017

Study Start

July 1, 2017

Primary Completion

October 20, 2018

Study Completion

October 20, 2018

Last Updated

August 17, 2018

Record last verified: 2018-06

Locations

CN(1)