TAH: Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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Placebo Comparator: hydroxyzine
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Drug: hydroxyzine
75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Other Names:
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Placebo Comparator: placebo starch tablet |
Drug: hydroxyzine
75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Other Names:
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Outcome Measures
Primary Outcome Measures
- successful treatment of pruritus [48 hour]
Secondary Outcome Measures
- successful treatment of nausea or vomiting [48 hours]
Eligibility Criteria
Criteria
Inclusion Criteria:
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ASA classification 1-2
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Age from 18-60 years old
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Body mass index (BMI) below 35
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Accepted combined spinal-general anesthesia
Exclusion Criteria:
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Previous history of Hydroxyzine allergy
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Underlying diseases of urticaria, pruritus, nausea vomiting and motion sickness
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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.- 168/2550(EC1)