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
  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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • successful treatment of pruritus [ Time Frame: 48 hour ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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
Vomiting
Pruritus
Signs and Symptoms, Digestive
Signs and Symptoms
Skin Diseases
Skin Manifestations
Hydroxyzine
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

ClinicalTrials.gov processed this record on September 16, 2014