Dexmedetomidine on Prevention of Side Effects of Hemabate

September 28, 2014 updated by: Jin Ni

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

gynecological patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jin Ni

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

August 14, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (ESTIMATE)

August 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 30, 2014

Last Update Submitted That Met QC Criteria

September 28, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JNi
  • DAGZWCMC (OTHER: Department of Anesthesiology,Guangzhou Women and Children's Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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