- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03705026
Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting in Chinese Han Population
Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting Undergoing Breast Surgery With General Anesthesia in Chinese Han Population
Study Overview
Status
Conditions
Detailed Description
Materials and methods:
Demographic data and risk factors responsible for PONV, including the history of PONV and motion sickness, were collected preoperatively by interviewing participants the day before anesthesia.
All study subjects received a standardized anesthesia regimen. General anesthesia was induced by midazolam 0.04 mg/kg, propofol 1.5 mg/kg, sufentanil 0.4 μg/kg, and cisatracurium 0.2 mg/kg (to facilitate tracheal intubation) given intravenously.Participants' lungs were ventilated with 50% oxygen in air.
During general anesthesia, concentration of sevoflurane maintained 1.0% to 3.0% at the discretion of anesthetist who was not involved in the study. General anesthesia also uses propofol 1 mg kg-1 h-1 and sufentanil 0.1 μg kg-1 h-1 by continuous intravenous infusion. An Entropy index monitor was used to maintain the appropriate anesthesia depth by 40-60. Participants received a repeated bolus of sufentanil 0.1 μg/kg or cisatracurium intravenously on demand.
After surgery the investigators recorded the data such as Anesthesia duration, doses of sufentanil and propofol and so on.
At the end of surgery and after returning to the ward, flurbiprofen axetil 50 mg injection i.v. was administered as an analgesic therapy, respectively. Cholinesterase inhibitor-based neuromuscular reversal drugs and vitamine B6 were not administered after surgery. Bucinnazine hydrochloride 100 mg intramuscular injection (i.m.) as a rescue medication was administered to any participant whose visual analogue scale/score (VAS) was > 3.
Ondansetron was given intravenously to the participants if necessary or requested . Unaware of the genotypes of the subjects, the investigators collected the participants' data including nausea, vomiting and pain.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Undergoing breast surgery with general anesthesia
- American Society of Anesthesiologists Physical Status Classifications 1-2
- No history of smoking
- body mass index (BMI) <35 kg/m2
Exclusion Criteria:
- Declined to participate
- Had used antiemetics, steroids, H2 antagonists, anticholinergics, antihistamines, butyrophenones, phenothiazines, metoclopramide or opioids within 24 hours
- Gastroesophageal reflux, gastrointestinal obstruction or ulcer, vestibular or hearing dysfunction
- Liver impairment, renal impairment, psychiatric disorder, chronic pain
- Pregnant and lactating patients
- Requiring postoperative patient-controlled analgesia
- Requiring prophylactic use of antiemetics
- Allergic to drugs related in the study
- Receiving chemotherapy within one week before surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whether the participants occur nausea or not
Time Frame: Period of 0 to 6 hours after surgery
|
Nausea was defined as a feeling of wanting to throw up or about to throw up.
|
Period of 0 to 6 hours after surgery
|
Whether the participants occur vomiting or not
Time Frame: Period of 0 to 6 hours after surgery
|
Vomiting was defined as the discharge of the stomach contents, while retching as an involuntary attempt to vomit that did not produce stomach contents.
Retching was considered as vomiting.
|
Period of 0 to 6 hours after surgery
|
Whether the participants occur nausea or not
Time Frame: Period of 6 to 24 hours after surgery
|
Nausea was defined as a feeling of wanting to throw up or about to throw up.
|
Period of 6 to 24 hours after surgery
|
Whether the participants occur vomiting or not
Time Frame: Period of 6 to 24 hours after surgery
|
Vomiting was defined as the discharge of the stomach contents, while retching as an involuntary attempt to vomit that did not produce stomach contents.
Retching was considered as vomiting.
|
Period of 6 to 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of nausea
Time Frame: Within 24 hours after surgery
|
The level of participants' nausea was rated on four-point scales: 0=no nausea; 1=mild nausea with activities; 2=mild nausea at rest; and 3=se-vere nausea at rest.
|
Within 24 hours after surgery
|
Number of vomiting
Time Frame: Within 24 hours after surgery
|
The investigators defined an emetic episode as a single occurrence of vomiting/retching or as a series of immediately successive vomiting/retching.
However, vomiting/retching had to be separated by at least 1 minute to be classified as a single emetic episode.
|
Within 24 hours after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Liangcheng Zhang, Ph.D, Fujian Medical University Union Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UnionAnesthesia
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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