Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting in Chinese Han Population

Completed

• Conditions: Breast Neoplasms; Anesthesia, General

• Registration Number: NCT03705026
• Lead Sponsor: Fujian Medical University Union Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2013-09-01
• Status Verified: 2018-10
• Study First Submitted: 2018-10-06
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-15
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Last Update Submitted: 2020-09-13
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 568

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whether the participants occur nausea or not	Period of 6 to 24 hours after surgery	Nausea was defined as a feeling of wanting to throw up or about to throw up.
Whether the participants occur vomiting or not	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.

Secondary Outcome Measures

Name	Time	Method
Level of nausea	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.
Number of vomiting	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.