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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pruritus Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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hydroxyzine

Group Type PLACEBO_COMPARATOR

hydroxyzine

Intervention Type DRUG

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

placebo

starch tablet

Group Type PLACEBO_COMPARATOR

hydroxyzine

Intervention Type DRUG

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

Interventions

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hydroxyzine

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

Intervention Type DRUG

Other Intervention Names

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atarax

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No