NCT01055236

Brief Summary

Hydroxyzine is one of antihistamines that antagonizes H1 receptor, and it's effects are reducing pruritus, nausea/vomiting, and the mild effect of sedation.With these effects Hydroxyzine should be used in the prevention of these symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 25, 2010

Completed
Last Updated

March 29, 2010

Status Verified

December 1, 2008

Enrollment Period

1.2 years

First QC Date

January 6, 2010

Last Update Submit

March 26, 2010

Conditions

PruritusNauseaVomiting

Keywords

sedation

Outcome Measures

Primary Outcomes (1)

  • successful treatment of pruritus

    48 hour

Secondary Outcomes (1)

  • successful treatment of nausea or vomiting

    48 hours

Study Arms (2)

hydroxyzine

PLACEBO COMPARATOR
Drug: hydroxyzine

placebo

PLACEBO COMPARATOR

starch tablet

Drug: hydroxyzine

Interventions

hydroxyzineDRUG

75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.

Also known as: atarax
hydroxyzineplacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA classification 1-2
  • Age from 18-60 years old
  • Body mass index (BMI) below 35
  • Accepted combined spinal-general anesthesia

You may not qualify if:

  • Previous history of Hydroxyzine allergy
  • Underlying diseases of urticaria, pruritus, nausea vomiting and motion sickness
  • Previous complications of procedure or anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

PruritusNauseaVomiting

Interventions

Hydroxyzine

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dr. Phuriphong Songarj, MD

    Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 25, 2010

Study Start

August 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

March 29, 2010

Record last verified: 2008-12

Locations

TH(1)