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

October 21, 2018 updated by: Yanmei-Bi, West China Second University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Second University Hospital

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

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Collaborators and Investigators

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

Sponsor

West China Second University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

June 28, 2017

Primary Completion (ACTUAL)

January 29, 2018

Study Completion (ACTUAL)

January 30, 2018

Study Registration Dates

First Submitted

June 10, 2017

First Submitted That Met QC Criteria

June 12, 2017

First Posted (ACTUAL)

June 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 21, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WESTCHINASUHA-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

published in paper form

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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