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

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01055236
First received: January 6, 2010
Last updated: March 26, 2010
Last verified: December 2008

January 6, 2010
March 26, 2010
August 2007
October 2008   (final data collection date for primary outcome measure)
successful treatment of pruritus [ Time Frame: 48 hour ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01055236 on ClinicalTrials.gov Archive Site
successful treatment of nausea or vomiting [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Pruritus
  • Nausea
  • Vomiting
Drug: hydroxyzine
75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Other Name: atarax
  • Placebo Comparator: hydroxyzine
    Intervention: Drug: hydroxyzine
  • Placebo Comparator: placebo
    starch tablet
    Intervention: Drug: hydroxyzine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01055236
168/2550(EC1)
No
Dr. Phuriphong Songarj, Department of Anesthesiology
Mahidol University
Not Provided
Study Director: Dr. Phuriphong Songarj, MD Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Mahidol University
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP