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The Preventive Effects of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate

W

West China Second University Hospital

Status and phase

Completed
Phase 4

Conditions

Nausea and Vomiting

Treatments

Drug: Propofol
Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03185156
WESTCHINASUHA-023

Details and patient eligibility

About

This is a randomized, placebo-controlled trail, the objective of this study is observation the effect of sub hypnotic dose of propofol for prevention of nausea and vomiting induced by hemabate during spinal anesthesia for elective cesarean section. The primary outcome is the presence of post-delivery intra-operative nausea and vomiting in parturients. The patients demographic characteristics, blood pressure, sensory block level, and the medications will be collected.

Enrollment

60 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged 20-40 years;
  • American Standards Association status I-II.

Exclusion criteria

  • Patients with allergy or hypersensitivity to propofol, lipid emulsion, or granisetron;
  • History of nausea or vomiting within 24h before cesarean delivery;
  • History of gastrointestinal or psychiatric disease, motion sickness, smoking, postoperative nausea and vomiting;
  • Morbid obesity;
  • Consumption of drugs such as opioids, antiemetics , H2 antagonists, phenothiazines and/or corticosteroids within 24h before the study period;
  • Any chronic medical or surgical disorders complicating the pregnancy;
  • Conditions contraindicating regional anesthesia.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

propofol group
Experimental group
Description:
first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump
Treatment:
Drug: Propofol
control group
Placebo Comparator group
Description:
first dose 0.03ml/Kg normal saline, then 0.1ml/Kg/hr micro-pump
Treatment:
Drug: Normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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