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

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ClinicalTrials.gov Identifier: NCT01055236
Recruitment Status : Completed
First Posted : January 25, 2010
Last Update Posted : March 29, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pruritus Nausea Vomiting Drug: hydroxyzine 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. successful treatment of pruritus [ Time Frame: 48 hour ]

Secondary Outcome Measures :
  1. successful treatment of nausea or vomiting [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055236


Locations
Thailand
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

Responsible Party: Dr. Phuriphong Songarj, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT01055236     History of Changes
Other Study ID Numbers: 168/2550(EC1)
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: March 29, 2010
Last Verified: December 2008

Keywords provided by Mahidol University:
sedation

Additional relevant MeSH terms:
Nausea
Vomiting
Pruritus
Signs and Symptoms, Digestive
Signs and Symptoms
Skin Diseases
Skin Manifestations
Morphine
Hydroxyzine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action