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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

Tracking Information
First Submitted Date  ICMJE August 14, 2014
First Posted Date  ICMJE August 19, 2014
Last Update Posted Date September 30, 2014
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
  • SpO2 Change [ Time Frame: participants will be followed for the duration of surgery, an expected average of 2 hours ]
  • 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 ]
  • Heart rate change [ Time Frame: participants will be followed for the duration of surgery, an expected average of 2 hours ]
  • nausea [ Time Frame: 24 h postoperatively ]
  • vomiting [ Time Frame: 24h postoperatively ]
  • fever [ Time Frame: 24h postoperatively ]
  • diarrhea [ Time Frame: 24h postoperatively ]
  • headache [ Time Frame: 24h postoperatively ]
  • elevated blood pressure [ Time Frame: 24h postoperatively ]
  • chest congestion [ Time Frame: 24h postoperatively ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine on Prevention of Side Effects of Hemabate
Official Title  ICMJE Phase 4 Study of Effects of Dexmedetomidine on Prevention of Side Effects of Hemabate in Cesarean Section Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Gynecological Patient
Intervention  ICMJE
  • Drug: placebo
    received 20 ml intravenous physiological saline The infusion were completed in 30 minutes.
  • 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.
  • 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
Study Arms  ICMJE
  • Placebo Comparator: placebo group
    received 20 ml intravenous physiological saline
    Intervention: Drug: placebo
  • 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
    Intervention: Drug: low dose dexmedetomidine
  • 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
    Intervention: Drug: high dose dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 18, 2014)		 120
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

gynecological patients

Exclusion Criteria:

  • Neuromuscular and endocrine diseases
  • Allergic reactions to a2-adrenergic agonist
  • Previous abdominal surgery including prior caesarean section.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02220361
Other Study ID Numbers  ICMJE JNi
DAGZWCMC ( Other Identifier: Department of Anesthesiology,Guangzhou Women and Children's Medical Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin Ni, Guangzhou Women and Children's Medical Center
Study Sponsor  ICMJE Jin Ni
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Guangzhou Women and Children's Medical Center
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP