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OpenTrials
Completed

NCT Number: NCT01055236

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hydroxyzine

Drug

75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.

Other names: atarax

Primary outcomes

  1. successful treatment of pruritus

    Time frame: 48 hour

Secondary outcomes

  1. successful treatment of nausea or vomiting

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Acronym: TAH

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 25, 2010
Registry last updated
Mar 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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