Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients (TAH)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pruritus Nausea Vomiting |
Drug: hydroxyzine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- successful treatment of pruritus [ Time Frame: 48 hour ] [ Designated as safety issue: Yes ]
- successful treatment of nausea or vomiting [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
| Enrollment: | 80 |
| Study Start Date: | August 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: hydroxyzine |
Drug: hydroxyzine
75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Other Name: atarax
|
|
Placebo Comparator: placebo
starch tablet
|
Drug: hydroxyzine
75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Other Name: atarax
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| 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| Thailand | |
| Siriraj Hospital | |
| Bangkoknoi, Bangkok, Thailand, 10700 | |
| Study Director: | Dr. Phuriphong Songarj, MD | Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand |
More Information
No publications provided
| Responsible Party: | Dr. Phuriphong Songarj, Department of Anesthesiology |
| ClinicalTrials.gov Identifier: | NCT01055236 History of Changes |
| Other Study ID Numbers: | 168/2550(EC1) |
| Study First Received: | January 6, 2010 |
| Last Updated: | March 26, 2010 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Mahidol University:
|
sedation |
Additional relevant MeSH terms:
|
Nausea Pruritus Vomiting Signs and Symptoms, Digestive Signs and Symptoms Skin Diseases Skin Manifestations Hydroxyzine Morphine Antipruritics Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 16, 2013