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Trial record 40 of 3342 for:    China Medicine University Hospital

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

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ClinicalTrials.gov Identifier: NCT03185156
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Yanmei-Bi, West China Second University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nausea and Vomiting Drug: Propofol Drug: Normal saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 60 maternal aged 20-40 years will be collected
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Preventive Effect of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate
Actual Study Start Date : June 28, 2017
Actual Primary Completion Date : January 29, 2018
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: propofol group
first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump
Drug: Propofol
first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump

Placebo Comparator: control group
first dose 0.03ml/Kg normal saline, then 0.1ml/Kg/hr micro-pump
Drug: Normal saline
first dose 0.03ml/Kg placebo saline, then 0.1ml/Kg/hr micro-pump




Primary Outcome Measures :
  1. The presence of nausea and vomiting [ Time Frame: 24 hours ]
    the patients were not asked directly about nausea during the course of the surgery, but its incidence was recorded when spontaneously reported vomiting was recorded as observed by investigator



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185156


Locations
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China, Sichuan
West China Second University Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Second University Hospital

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Responsible Party: Yanmei-Bi, Principal Investigator, West China Second University Hospital
ClinicalTrials.gov Identifier: NCT03185156     History of Changes
Other Study ID Numbers: WESTCHINASUHA-023
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: published in paper form
Supporting Materials: Study Protocol
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yanmei-Bi, West China Second University Hospital:
nausea and vomiting
hemabate
propofol

Additional relevant MeSH terms:
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Physiological Effects of Drugs
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Propofol
Hypnotics and Sedatives
Carboprost tromethamine
Carboprost
Central Nervous System Depressants
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Oxytocics
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents