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NCT Number: NCT03705026

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Registry information

Official study title

Relationship Between Genetic Polymorphism and Postoperative Nausea and Vomiting Undergoing Breast Surgery With General Anesthesia in Chinese Han Population

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Oct 15, 2018
Registry last updated
Sep 16, 2020

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

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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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