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

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT01055236
Collaborator
(none)
80
1
2
14
5.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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 Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Oct 1, 2008
Actual Study Completion Date :
Oct 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: hydroxyzine

Drug: hydroxyzine
75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Other Names:
  • atarax
  • Placebo Comparator: placebo

    starch tablet

    Drug: hydroxyzine
    75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
    Other Names:
  • atarax
  • Outcome Measures

    Primary Outcome Measures

    1. successful treatment of pruritus [48 hour]

    Secondary Outcome Measures

    1. successful treatment of nausea or vomiting [48 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Siriraj Hospital Bangkoknoi Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Study Director: Dr. Phuriphong Songarj, MD, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01055236
    Other Study ID Numbers:
    • 168/2550(EC1)
    First Posted:
    Jan 25, 2010
    Last Update Posted:
    Mar 29, 2010
    Last Verified:
    Dec 1, 2008
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2010