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

NCT03185156 | Completed Phase 4 DMC

• 1 other identifier: WESTCHINASUHA-023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea and Vomiting

Keywords

nausea and vomiting; hemabate; propofol

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Study Arms (2)

propofol group

EXPERIMENTAL

first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump

Drug: Propofol

control group

PLACEBO COMPARATOR

first dose 0.03ml/Kg normal saline, then 0.1ml/Kg/hr micro-pump

Drug: Normal saline

Interventions

Propofol DRUG

first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump

propofol group

Normal saline DRUG

first dose 0.03ml/Kg placebo saline, then 0.1ml/Kg/hr micro-pump

control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (1)

West China Second University Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• 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.

  PMID: 33993473 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Propofol; Saline Solution

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 60 maternal aged 20-40 years will be collected

Study Record Dates

• First Submitted: June 10, 2017
• First Posted: June 14, 2017
• Study Start: June 28, 2017
• Primary Completion: January 29, 2018
• Study Completion: January 30, 2018
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CN (1)