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NCT Number: NCT04112771

Penehyclidine and Postoperative Nausea and Vomiting After Bimaxillary Surgery

Postoperative nausea and vomiting (PONV) are common complications after surgery. Patients undergoing orthognathic surgery are reported to have a high rate of PONV, especially those undergoing bimaxillary surgery. Activation of cholinergic system plays an important role in the development of PONV. Penehyclidine is an muscarinic antagonists which selectively block M1 and M3 receptors and is commonly used to decrease oral secretion. The purpose of this retrospective cohort study is to investigate whether use of penehyclidine is associated with a reduced risk of PONV in patients undergoing bimaxillary surgery.

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Key information

Conditions

Penehyclidine Bimaxillar Surgery Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Hospital of Stomatology, Beijing, Beijing Municipality, China

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About this study

Postoperative nausea and vomiting (PONV) are one of the most frequent complications after surgery, and are associated with patients' dissatisfaction after anesthesia and surgery. Orthognathic surgery is widely performed for the correction of dentofacial deformities. PONV is common after orthognathic surgery. Despite of improved anti-emetic prophylaxis, patients undergoing orthognathic surgery are reported to have a high incidence of PONV, especially those after bimaxillary surgery.

It is known that activation of central cholinergic system plays an important role in the development of PONV. Muscarinic antagonists such as scopolamine can block muscarinic receptors in the cerebral cortex and produce anti-emetic effects. Penehyclidine is a new muscarinic antagonists which selectively block M1 and M3 receptors. It has fewer adverse effects compared with other anticholinergics. The purpose of this retrospective cohort study is to investigate whether use of penehyclidine is associated with a reduce risk of PONV in patients undergoing bimaxillary surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥16 years;
  • Underwent elective bimaxillary surgery under general anesthesia.

Exclusion criteria

  • Age <16 years;
  • Missing data.

Treatment and study plan

Penehyclidine hydrochloride

Drug

Penehyclidine hydrochloride was administered before anesthesia induction.

No penehyclidine hydrochloride

Other

Penehyclidine hydrochloride was not administered before anesthesia induction.

Primary outcomes

  1. Postoperative nausea and vomiting (PONV) within 48 hours after bimaxillary surgery.

    Time frame: Up to 48 hours after surgery.

    Nausea was assessed by direct questioning. Vomiting was diagnosed when patients retched or expulsed intra-gastric contents.

Secondary outcomes

  1. Daily prevalence of PONV.

    Time frame: Up to 48 hours after surgery.

    Daily prevalence of PONV on the day of surgery, as well as the first and second day after surgery.

  2. Postoperative agitation after bimaxillary surgery.

    Time frame: Up to 8:00 am on the first day after surgery.

    Postoperative agitation was diagnosed when a Richmond Agitation-Sedation Scale (scale ranges from -5 to +4, with higher scale indicating severe agitation) reached +2 or more at any time within 2 hours after extubation.

  3. Postoperative pain after bimaxillary surgery.

    Time frame: Up to 2 days after surgery.

    Postoperative pain was assessed with the Numeric Rating Scale (an 11-point scale where 0=no pain and 10=the worst pain). A score of 4 or more is defined a moderate-to-severe pain.

  4. Postoperative complications during hospital stay after surgery.

    Time frame: Up to 30 days after surgery.

    Postoperative complications were generally defined as new-onset medical events that were harmful for patients' recovery and required therapeutic intervention.

  5. Length of stay in hospital after surgery.

    Time frame: Up to 30 days after surgery.

    Length of stay in hospital after surgery.

  6. In-hospital mortality after surgery.

    Time frame: Up to 30 days after surgery.

    In-hospital mortality after surgery.

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Peking University Hospital of Stomatology

Registry information

Official study title

Effects of Penehyclidine on Postoperative Nausea and Vomiting in Patients Underging Bimaxillary Surgery: A Retrospective Cohort Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 2, 2019
Registry last updated
Jun 30, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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