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Dexmedetomidine on Prevention of Side Effects of Hemabate

NCT ID: NCT02220361

Last Updated: 2014-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Gynecological Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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placebo group

received 20 ml intravenous physiological saline

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

low dose dexmedetomidine

Intervention Type DRUG

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.

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

Group Type EXPERIMENTAL

high dose dexmedetomidine

Intervention Type DRUG

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

Interventions

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placebo

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

Intervention Type 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.

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

gynecological patients

Exclusion Criteria

* Neuromuscular and endocrine diseases
* Allergic reactions to a2-adrenergic agonist
* Previous abdominal surgery including prior caesarean section.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Jin Ni

OTHER

Sponsor Role lead

Responsible Party

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Jin Ni

Department of Anesthesiology

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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DAGZWCMC

Identifier Type: OTHER

Identifier Source: secondary_id

JNi

Identifier Type: -

Identifier Source: org_study_id