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

Phase 4

Completed

• Conditions: Pruritus; Nausea; Vomiting
• Interventions: Drug: hydroxyzine

• Registration Number: NCT01055236
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2008-12
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Last Update Submitted: 2010-03-26
• Last Update Posted: 2010-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	hydroxyzine	starch tablet
hydroxyzine	hydroxyzine	-

Primary Outcome Measures

Name	Time	Method
successful treatment of pruritus	48 hour

Secondary Outcome Measures

Name	Time	Method
successful treatment of nausea or vomiting	48 hours

Trial Locations

Locations (1)

Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand