Dexmedetomidine on Prevention of Side Effects of Hemabate

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02220361

Enrollment

120

Registered

2014-08-19

Start date

2014-09-30

Completion date

2014-12-31

Last updated

2014-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecological Patient

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.

Interventions

DRUGplacebo

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

DRUGlow 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.

DRUGhigh 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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

gynecological patients

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026