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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2008

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.

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: hydroxyzine
  • Placebo Comparator: placebo
    • starch tablet

Clinical Trial Outcome Measures

Primary Measures

  • successful treatment of pruritus
    • Time Frame: 48 hour

Secondary Measures

  • successful treatment of nausea or vomiting
    • Time Frame: 48 hours

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 60 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Mahidol University
    • Provider of Information About this Clinical Study
      • Dr. Phuriphong Songarj, Department of Anesthesiology
    • Overall Official(s)
      • Dr. Phuriphong Songarj, MD, Study Director, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand

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