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

Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185156
• Other study ID #: WESTCHINASUHA-023
• Status: Completed
• Phase: Phase 4
• Start date: June 28, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: October 2018
• Source: West China Second University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2018
• Est. primary completion date: January 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Propofol
first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump
• Normal saline
first dose 0.03ml/Kg placebo saline, then 0.1ml/Kg/hr micro-pump

Locations

Country	Name	City	State
China	West China Second University Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Second University Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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