Dexmedetomidine on Prevention of Side Effects of Hemabate

Phase 4

• Conditions: Gynecological Patient
• Interventions: Drug: low dose dexmedetomidine; Drug: placebo; Drug: high dose dexmedetomidine

• Registration Number: NCT02220361
• Lead Sponsor: Jin Ni

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-14
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-19
• Status Verified: 2014-09
• Study Start: 2014-09
• Last Update Submitted: 2014-09-28
• Last Update Posted: 2014-09-30
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

gynecological patients

Exclusion Criteria

• Neuromuscular and endocrine diseases
• Allergic reactions to a2-adrenergic agonist
• Previous abdominal surgery including prior caesarean section.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose dexmedetomidine group	low dose dexmedetomidine	received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline
placebo group	placebo	received 20 ml intravenous physiological saline
hemabate+high dose dexmedetomidine group	high dose dexmedetomidine	received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline

Primary Outcome Measures

Name	Time	Method
nausea	24 h postoperatively
vomiting	24h postoperatively
elevated blood pressure	24h postoperatively
fever	24h postoperatively
SpO2 Change	participants will be followed for the duration of surgery, an expected average of 2 hours
diarrhea	24h postoperatively
headache	24h postoperatively
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
chest congestion	24h postoperatively