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Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients (TAH)

Primary Purpose

Pruritus, Nausea, Vomiting

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
hydroxyzine
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pruritus focused on measuring sedation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Placebo Comparator

Arm Label

hydroxyzine

placebo

Arm Description

starch tablet

Outcomes

Primary Outcome Measures

successful treatment of pruritus

Secondary Outcome Measures

successful treatment of nausea or vomiting

Full Information

First Posted
January 6, 2010
Last Updated
March 26, 2010
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01055236
Brief Title
Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients
Acronym
TAH
Official Title
Hydroxyzine for the Prevention of Pruritus and Nausea Vomiting From Spinal Morphine in Patients Having Transabdominal Hysterectomy Under Combined Spinal-general Anesthesia: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
80 patients scheduled for elective transabdominal hysterectomy under combined spinal-general anesthesia. they were randomized to receive either hydroxyzine 75 mg and midazolam 7.5 mg (ATR group) or placebo and midazolam 7.5 mg (control group) as premedication at least half an hour before operation. Clinical data (vital signs, pruritic score, nauseous score, sedation score, etc) was recorded at preoperative, intraoperative and 48-hour postoperative periods. All patients had spinal block with 0.5% heavy bupivacaine 2 ml with 0.3 mg preservative free morphine and general anesthesia with thiopental sodium 250-300 mg as induction, intubated with atracurium 0.6 mg/kg and maintenance with nitrous oxide, oxygen and isoflurane. Conventional reversal technique was done in all patients. Fentanyl intravenous was used for pain as needed, chlopheniramine syrup 2 tsp (4mg/10 ml) every 4 hours was used for pruritus and ondansetron intravenous (8 mg) was used for nausea/vomiting in postoperative period. The results were reported in number of patients or percent of patients who were suffered from pruritus, nausea, vomiting or sedation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Nausea, Vomiting
Keywords
sedation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hydroxyzine
Arm Type
Placebo Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
starch tablet
Intervention Type
Drug
Intervention Name(s)
hydroxyzine
Other Intervention Name(s)
atarax
Intervention Description
75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Primary Outcome Measure Information:
Title
successful treatment of pruritus
Time Frame
48 hour
Secondary Outcome Measure Information:
Title
successful treatment of nausea or vomiting
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA classification 1-2 Age from 18-60 years old Body mass index (BMI) below 35 Accepted combined spinal-general anesthesia Exclusion Criteria: Previous history of Hydroxyzine allergy Underlying diseases of urticaria, pruritus, nausea vomiting and motion sickness Previous complications of procedure or anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Phuriphong Songarj, MD
Organizational Affiliation
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Official's Role
Study Director
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients

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