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Dexmedetomidine on Prevention of Side Effects of Hemabate

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ClinicalTrials.gov Identifier: NCT02220361
Recruitment Status : Unknown
Verified September 2014 by Jin Ni, Guangzhou Women and Children's Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : August 19, 2014
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):
Jin Ni, Guangzhou Women and Children's Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gynecological Patient Drug: placebo Drug: low dose dexmedetomidine Drug: high dose dexmedetomidine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Effects of Dexmedetomidine on Prevention of Side Effects of Hemabate in Cesarean Section Patients
Study Start Date : September 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: placebo group
received 20 ml intravenous physiological saline
 Drug: placebo
received 20 ml intravenous physiological saline The infusion were completed in 30 minutes.
Experimental: low dose dexmedetomidine group
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
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.
Experimental: hemabate+high dose dexmedetomidine group
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

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


Outcome Measures
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Primary Outcome Measures :
  1. SpO2 Change [ Time Frame: participants will be followed for the duration of surgery, an expected average of 2 hours ]
  2. systolic blood pressure and diastolic blood pressure change [ Time Frame: participants will be followed for the duration of surgery, an expected average of 2 hours ]
  3. Heart rate change [ Time Frame: participants will be followed for the duration of surgery, an expected average of 2 hours ]
  4. nausea [ Time Frame: 24 h postoperatively ]
  5. vomiting [ Time Frame: 24h postoperatively ]
  6. fever [ Time Frame: 24h postoperatively ]
  7. diarrhea [ Time Frame: 24h postoperatively ]
  8. headache [ Time Frame: 24h postoperatively ]
  9. elevated blood pressure [ Time Frame: 24h postoperatively ]
  10. chest congestion [ Time Frame: 24h postoperatively ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

gynecological patients

Exclusion Criteria:

  • Neuromuscular and endocrine diseases
  • Allergic reactions to a2-adrenergic agonist
  • Previous abdominal surgery including prior caesarean section.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Jin Ni, Department of Anesthesiology, Guangzhou Women and Children's Medical Center
ClinicalTrials.gov Identifier: NCT02220361    
Other Study ID Numbers: JNi
DAGZWCMC ( Other Identifier: Department of Anesthesiology,Guangzhou Women and Children's Medical Center )
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action