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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Pruritus, Nausea, Vomiting

Intervention / Treatment
-----------------
* Drug: hydroxyzine


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: hydroxyzine<br> | Drug: hydroxyzine<br>* 75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.<br>* Other names: atarax;|
| Placebo Comparator: placebo<br>starch tablet | Drug: hydroxyzine<br>* 75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.<br>* Other names: atarax;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful treatment of pruritus |  | 48 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| successful treatment of nausea or vomiting |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedation