NCT06345261

Brief Summary

Diphenhydramine has H1-antihistamine action, it also possesses anti-muscarinic properties. Thus, diphenhydramine might be able to reduce the problem of catheter related bladder discomfort by inhibiting smooth muscle spasm of the urinary bladder via its anti-muscarinic action .

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

March 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 3, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 28, 2024

Last Update Submit

March 28, 2024

Conditions

Catheter Complications

Outcome Measures

Primary Outcomes (1)

  • incidence of catheter related bladder discomfort postoperative

    * none, did not complain of any CRBD even upon asking. * mild, revealed only on questioning. * moderate, reported without questioning but not accompanied by any behavioral response. * severe, stated on their own and followed by behavioral responses such as a strong verbal response, flailing limbs, and even attempting to pull out the urinary catheter

    UP TO 6 HOURE

Secondary Outcomes (1)

  • visual analog scale (VAS)

    up to 6 hours

Study Arms (2)

Diphenhydramine group

ACTIVE COMPARATOR
Drug: DiphenhydrAMINE 50 Mg/mL Injectable Solution

control group

PLACEBO COMPARATOR
Drug: Saline

Interventions

DiphenhydrAMINE 50 Mg/mL Injectable SolutionDRUG

injection of Diphenhydramine 50 Mg/mL

Diphenhydramine group
SalineDRUG

injection of saline

control group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male patients aged more than18-80 years ASA I and II , upper ureteric stone removal under general anesthesia r

You may not qualify if:

  • overactive bladder cognitive impairment a neuropsychological disorder, bladder outflow obstruction urinary tract infection, , neurogenic bladder, operative time \> 6 h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, 11562, Egypt

Location

MeSH Terms

Interventions

DiphenhydramineSodium Chloride

Intervention Hierarchy (Ancestors)

EthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Amr s wahdan, MD

    Cairo university , Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 28, 2024

First Posted

April 3, 2024

Study Start

April 1, 2024

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

April 3, 2024

Record last verified: 2024-03

Locations

EG(1)