Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery

Study Overview
=================
Brief Summary
-----------------
This study is about the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery. It is well known that pituitrin has been widespread used in the laparoscopic hysteromyoma surgery. Pituitrin includes oxytocin and vasopressin. Vasopressin increase body stress reaction through hypothalamic pituitary adrenal(HPA) axis. The HPA axis has has main role to the body stress reaction. Dexmedetomidine can inhibit the stress responses mediated by the sympathetic nervous system. Therefore,the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery is worth to be studied.

Official Title
-----------------
Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery

Conditions
-----------------
Hysteromyoma

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgery will be scheduled as first case in the morning at 9 Am. On arrival to the operation room, intravenous access will be achieved with venous cannula under local anesthesia with 2% lidocaine. Monitoring consisted of 5 lead electrocardiography, pulse oximeter, noninvasive blood pressure, end tidal carbon dioxide, and bispectral index. Exclusion Criteria: Diabetic,chronic hypertension,patients on drugs such as beta blockers or calcium channel blockers,pregnant or lactating women, patients with abnormal serum creatinine and blood urea nitrogen, and patients with a history of allergy to drugs particularly α2 agonists.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: no dexmedetomidine<br> | |
| Experimental: high dose dexmedetomidine<br> | Drug: Dexmedetomidine<br>* Ninety patients will be assigned to three groups. Group A add saline in general anesthesia laparoscopic hysteromyoma surgery. Group B add dexmedetomidine 1μg/Kg10minutes as loading dose, followed by 0.7μg/Kg/h for maintenance.Group C add dexmedetomidine 0.7μg/Kg10minutes as loading dose, followed by 0.5μg/Kg/h for maintenance.<br>|
| Experimental: low dose dexmedetomidine<br> | Drug: Dexmedetomidine<br>* Ninety patients will be assigned to three groups. Group A add saline in general anesthesia laparoscopic hysteromyoma surgery. Group B add dexmedetomidine 1μg/Kg10minutes as loading dose, followed by 0.7μg/Kg/h for maintenance.Group C add dexmedetomidine 0.7μg/Kg10minutes as loading dose, followed by 0.5μg/Kg/h for maintenance.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acth | adrenocorticotropic hormone | the acth before using pituitrin 5 minutes | 
| acth | adrenocorticotropic hormone | the acth after using pituitrin 20 minutes | 
| acth | adrenocorticotropic hormone | the acth after using pituitrin 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress, dexmedetomidine