- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01055236
Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients (TAH)
March 26, 2010 updated by: Mahidol University
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
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
-
Bangkoknoi, Bangkok, Thailand, 10700
- Siriraj Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: hydroxyzine
|
75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Other Names:
|
Placebo Comparator: placebo
starch tablet
|
75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
successful treatment of pruritus
Time Frame: 48 hour
|
48 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
successful treatment of nausea or vomiting
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dr. Phuriphong Songarj, MD, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
January 6, 2010
First Submitted That Met QC Criteria
January 22, 2010
First Posted (Estimate)
January 25, 2010
Study Record Updates
Last Update Posted (Estimate)
March 29, 2010
Last Update Submitted That Met QC Criteria
March 26, 2010
Last Verified
December 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Signs and Symptoms, Digestive
- Skin Manifestations
- Nausea
- Vomiting
- Pruritus
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Dermatologic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Hydroxyzine
Other Study ID Numbers
- 168/2550(EC1)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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