An observational study in Breast Neoplasms and Anesthesia, General, sponsored by Fujian Medical University Union Hospital. Completed. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Fujian Medical University Union Hospital · Observational
Postoperative nausea and vomiting ( PONV ) is one of the common complications after general anesthesia while genetic factors may play an important role in Postoperative nausea and vomiting. In this study, the investigators investigated the relationship between gene polymorphism ( such as single nucleotide polymorphism ) of the gene HTR3A ( 5-hydroxytryptamine receptor 3A ), HTR3B ( 5-hydroxytryptamine receptor 3B ), HTR3C ( 5-hydroxytryptamine receptor 3C ) and TACR1 ( tachykinin receptor 1 ) etc. with nausea and vomiting after general anesthesia. Simultaneously, the investigators explored the influencing factors of nausea and vomiting.
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 568 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fujian Medical University Union Hospital is the lead sponsor of 100 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Han population who were admitted to department of breast surgery, Fujian Medical University Union Hospital.
Exclusion Criteria:
Whether the participants occur nausea or not
Nausea was defined as a feeling of wanting to throw up or about to throw up.
Time frame: Period of 0 to 6 hours after surgery
Whether the participants occur vomiting or not
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.
Time frame: Period of 0 to 6 hours after surgery
Whether the participants occur nausea or not
Nausea was defined as a feeling of wanting to throw up or about to throw up.
Time frame: Period of 6 to 24 hours after surgery
Whether the participants occur vomiting or not
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.
Time frame: Period of 6 to 24 hours after surgery
Level of nausea
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.
Time frame: Within 24 hours after surgery
Number of vomiting
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.
Time frame: Within 24 hours after surgery
No study locations are listed for this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Fujian Medical University Union Hospital