Dexmedetomidine on Prevention of Side Effects of Hemabate

Study Overview
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Brief Summary
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Hemabate is often used for gynecological patients. Hemabate is associated with many side effects, including a burning sensation in the stomach, nausea, vomiting, diarrhea etc. It is reported that dexmedetomidine reduce gastrointestinal reaction during perioperative period. We design this clinical trial to find if dexmedetomidine can prevent the side effects of hemabate in Cesarean Section patients.

Official Title
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Phase 4 Study of Effects of Dexmedetomidine on Prevention of Side Effects of Hemabate in Cesarean Section Patients

Conditions
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Gynecological Patient

Intervention / Treatment
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* Drug: placebo
* Drug: low dose dexmedetomidine
* Drug: high dose dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gynecological patients Exclusion Criteria: Neuromuscular and endocrine diseases Allergic reactions to a2-adrenergic agonist Previous abdominal surgery including prior caesarean section.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo group<br>received 20 ml intravenous physiological saline | Drug: placebo<br>* received 20 ml intravenous physiological saline The infusion were completed in 30 minutes.<br>|
| Experimental: low dose dexmedetomidine group<br>received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline | Drug: low dose dexmedetomidine<br>* received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline The infusion were completed in 30 minutes.<br>|
| Experimental: hemabate+high dose dexmedetomidine group<br>received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline | Drug: high dose dexmedetomidine<br>* received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline. The infusion was completed in 30 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpO2 Change |  | participants will be followed for the duration of surgery, an expected average of 2 hours | 
| systolic blood pressure and diastolic blood pressure change |  | participants will be followed for the duration of surgery, an expected average of 2 hours | 
| Heart rate change |  | participants will be followed for the duration of surgery, an expected average of 2 hours | 
| nausea |  | 24 h postoperatively | 
| vomiting |  | 24h postoperatively | 
| fever |  | 24h postoperatively | 
| diarrhea |  | 24h postoperatively | 
| headache |  | 24h postoperatively | 
| elevated blood pressure |  | 24h postoperatively | 
| chest congestion |  | 24h postoperatively |