NCT02220361

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 30, 2014

Status Verified

September 1, 2014

Enrollment Period

3 months

First QC Date

August 14, 2014

Last Update Submit

September 28, 2014

Conditions

Gynecological Patient

Outcome Measures

Primary Outcomes (10)

  • 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

Study Arms (3)

placebo group

PLACEBO COMPARATOR

received 20 ml intravenous physiological saline

Drug: placebo

low dose dexmedetomidine group

EXPERIMENTAL

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

hemabate+high dose dexmedetomidine group

EXPERIMENTAL

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

Interventions

placeboDRUG

received 20 ml intravenous physiological saline The infusion were completed in 30 minutes.

placebo group
low dose dexmedetomidineDRUG

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.

low dose dexmedetomidine group
high dose dexmedetomidineDRUG

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

hemabate+high dose dexmedetomidine group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • gynecological patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Anesthesiology

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 19, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 30, 2014

Record last verified: 2014-09