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NCT Number: NCT03185156

The Preventive Effects 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.

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Key information

Conditions

Nausea and Vomiting Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

West China Second University Hospital

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

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

normal saline

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

West China Second University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 14, 2017
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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