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

Phase 4

Completed

• Conditions: Nausea and Vomiting
• Interventions: Drug: Normal saline; Drug: Propofol

• Registration Number: NCT03185156
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-10
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Study Start: 2017-06-28
• Primary Completion: 2018-01-29
• Study Completion: 2018-01-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-21
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Normal saline	first dose 0.03ml/Kg normal saline, then 0.1ml/Kg/hr micro-pump
propofol group	Propofol	first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump

Primary Outcome Measures

Name	Time	Method
The presence of nausea and vomiting	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

Trial Locations

Locations (1)

West China Second University Hospital; 🇨🇳 Chengdu, Sichuan, China