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NCT Number: NCT04454866

Penehyclidine for Prevention of Nausea and Vomiting After Bimaxillary Surgery

Postoperative nausea and vomiting (PONV) is a common complication 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 investigators hypothesize that continuously administrated penehyclidine during perioperative period can reduce the incidence 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

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Univeristy Hospital Stomatology

Beijing, 100081, China

About this study

Postoperative nausea and vomiting (PONV) is one of the most frequently occurred complications after surgery, and are associated with patients' dissatisfaction after anesthesia and surgery. Orthognathic surgery is widely performed for the correction of dentofacial deformities. 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. Our previous study indicated that single-dose of penehyclidine injected before anesthesia induction was associated with a reduced risk of PONV during the first 6 h postoperatively.The mean elimination half-life of penehyclidine following single administration is about 10.35 h. Hence, a single-dose penehyclidine may only produce a short duration of antiemetic effect.

The investigators hypothesize that continuously administrated penehyclidine during perioperative period reduces PONV more effectively than single-dose injection in patients undergoing bimaxillary surgery. The purpose of this study is to investigate the effect of continuous administered penehyclidine in preventing 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 ≥18 years but <60 years; body mass index ≥18 but <30 kg/m2;
  • Scheduled to undergo elective bimaxillary surgery under general anesthesia;
  • Planned to use patient-controlled intravenous analgesia (PCIA) after surgery;
  • Provide written informed consents.

Exclusion criteria

  • Presence of glaucoma;
  • Allergic to penehyclidine, atropine, scopolamine or other anticholinergic drugs;
  • Acute or chronic nausea and/or vomiting, or gastrointestinal motility disorders before surgery;
  • Preoperative antiemetic therapy within 12 hours;
  • History of schizophrenia, Parkinson's disease or profound dementia, or language barrier;
  • Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (requirement of renal replacement therapy before surgery) or American Society of Anesthesiologists physical status ≥IV.

Treatment and study plan

Single injection of penehyclidine

Drug

A dose of penehyclidine hydrochloride (0.5 mg/5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of placebo (normal saline 5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.

Other names: Penehyclidine hydrochloride

Continuous infusion of penehyclidine

Drug

A dose of penehyclidine hydrochloride (0.25 mg/5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of penehyclidine hydrochloride (0.25 mg/5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.

Other names: Penehyclidine hydrochloride

Placebo

Drug

A dose of placebo (normal saline 5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of placebo (normal saline 5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.

Other names: Normal saline

Primary outcomes

  1. Incidence of nausea and vomiting within 72 hours after bimaxillary surgery.

    Time frame: Up to 72 hours after surgery.

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

Secondary outcomes

  1. Incidence of nausea and vomiting at different stages after bimaxillary surgery.

    Time frame: Up to 72 hours after surgery.

    Postoperative 0-6 h, 6-12 h, 12-24 h, 24-48 h, and 48-72 h. Nausea was assessed by direct questioning. Vomiting was diagnosed when patients retched or expulsed intra-gastric contents.

  2. Incidence of moderate to severe nausea at different stages after bimaxillary surgery.

    Time frame: Up to 72 hours after surgery.

    Postoperative 0-6 h, 6-12 h, 12-24 h, 24-48 h, and 48-72 h. Severity of nausea is assessed with the numerical rating scale (NRS; an 11-point scale where 0=no nausea and 10=the worst nausea). A score of 4 or higher is defined as moderate to severe nausea.

  3. Incidence of moderate to severe nausea within 72 hours after bimaxillary surgery.

    Time frame: Up to 72 hours after surgery.

    Severity of nausea is assessed with the numerical rating scale (NRS; an 11-point scale where 0=no nausea and 10=the worst nausea). A score of 4 or higher is defined as moderate to severe nausea.

  4. Severity of nausea and vomiting within 72 hours after bimaxillary surgery.

    Time frame: Up to 72 hours after surgery.

    Level I: Absence of any emetic symptoms and nausea during the entire study period.

    Level II: Occurrence of mild nausea or one episode of vomiting if caused by an exogenous stimulus (e.g., drinking or movement).

    Level III: Moderate to severe nausea, or vomiting for 2 times or more, or experiences nausea that required a rescue antiemetic therapy only once.

    Level IV: Patient is suffered more than two emetic episodes or necessitating more than one dose of a rescue antiemetic.

  5. Use of rescue antiemetics within 72 hours after bimaxillary surgery.

    Time frame: Up to 72 hours after surgery.

    Frequency and dose of antiemetics.

  6. Incidence of delirium within the first 5 days after surgery

    Time frame: Up to 5 days after surgery.

    Incidence of delirium within the first 5 days after surgery.

  7. Length of stay in hospital after surgery.

    Time frame: Up to 30 days after surgery.

    Length of stay in hospital after surgery.

  8. Incidence of complications within 30 days after surgery.

    Time frame: Up to 30 days after surgery.

    Incidence of complications within 30 days after surgery.

  9. All-cause 30-day mortality.

    Time frame: Within 30 days after surgery.

    All-cause 30-day mortality.

  10. Cognitive function on the 30th day after surgery.

    Time frame: At 30 days after surgery

    Cognitive function is assessed with the modified Telephone Interview for Cognitive Status (TICS-m; a 12-item questionnaire that provides an assessment of global cognitive function by verbal communication via telephone. The score ranges from 0 to 50, with higher score indicating better function).

Other outcomes

  1. Incidence of moderate to severe pain at different stages after bimaxillary surgery.

    Time frame: Up to 72 hours after surgery.

    Postoperative 0-6 h, 6-12 h, 12-24 h, 24-48 h, and 48-72 h. Pain intensity is assessed with the numerical rating scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain). A score of 4 or higher is defined as moderate to severe pain.

  2. Use of rescue analgesics within 72 hours after bimaxillary surgery.

    Time frame: Up to 72 hours after surgery.

    Frequency and dose of analgesics.

  3. Subjective sleep quality within 3 days after bimaxillary surgery.

    Time frame: In the morning of the 1st, 2nd, and 3rd days after surgery.

    Subjective sleep quality is assessed with the numeric rating scale (NRS; an 11-point scale where 0=the worst sleep and 10=the best sleep).

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Collaborators

  • Peking University Hospital of Stomatology

Registry information

Official study title

Effects of Penehyclidine in Preventing Postoperative Nausea and Vomiting in Patients Underging Bimaxillary Surgery: A Randomised Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2020
Registry last updated
Sep 16, 2021

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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