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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2018-01-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

60 maternal aged 20-40 years will be collected

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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propofol group

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

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

control group

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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Propofol

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No