Back to resultsThe Preventive Effects of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate
Primary Purpose
Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Propofol
Normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Nausea and Vomiting focused on measuring nausea and vomiting, hemabate, propofol
Eligibility 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.
Sites / Locations
- West China Second University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
propofol group
control group
Arm Description
first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump
first dose 0.03ml/Kg normal saline, then 0.1ml/Kg/hr micro-pump
Outcomes
Primary Outcome Measures
The presence of nausea and vomiting
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03185156
First Posted
June 10, 2017
Last Updated
October 21, 2018
Sponsor
West China Second University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03185156
Brief Title
The Preventive Effects of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate
Official Title
The Preventive Effect of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
January 29, 2018 (Actual)
Study Completion Date
January 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Second University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting
Keywords
nausea and vomiting, hemabate, propofol
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
60 maternal aged 20-40 years will be collected
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
propofol group
Arm Type
Experimental
Arm Description
first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
first dose 0.03ml/Kg normal saline, then 0.1ml/Kg/hr micro-pump
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
first dose 0.03ml/Kg placebo saline, then 0.1ml/Kg/hr micro-pump
Primary Outcome Measure Information:
Title
The presence of nausea and vomiting
Description
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
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
West China Second University Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
published in paper form
Citations:
PubMed Identifier
33993473
Citation
Bi Y, Zhong R, Huang J, Huang H. Effect of continuous infusion of a subhypnotic dose of propofol on nausea and vomiting after carboprost administration at cesarean delivery: A randomized, double-blind, placebo-controlled trial. Int J Gynaecol Obstet. 2022 May;157(2):283-288. doi: 10.1002/ijgo.13742. Epub 2021 Jun 9.
Results Reference
derived
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The Preventive Effects of Sub Hypnotic Dose of Propofol for Nausea and Vomiting Induced by Hemabate
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