Penehyclidine for prevention of postoperative nausea and vomiting following bimaxillary orthognathic surgery: a randomized, double-blind, controlled trial

Li-Kuan Wang, Tong Cheng, Xu-Dong Yang, Guo-Li Xiong, Nan Li, Dong-Xin Wang, Li-Kuan Wang, Tong Cheng, Xu-Dong Yang, Guo-Li Xiong, Nan Li, Dong-Xin Wang

Abstract

Purpose: To investigate the efficacy and safety of low-dose bolus plus continuous infusion of penehyclidine in preventing postoperative nausea and vomiting (PONV) following bimaxillary surgery.

Methods: Three hundred fifty-four patients were randomly allocated into three groups. In the Control group, placebo (normal saline) was injected before anesthesia and infused over 48 h after surgery; in the Bolus group, 0.5 mg penehyclidine was injected before anesthesia, whereas placebo was infused after surgery; in the Infusion group, 0.25 mg penehyclidine were injected before anesthesia, another 0.25 mg penehyclidine was infused after surgery. The primary endpoint was the incidence of PONV within 72 h.

Results: A total of 353 patients were included in intention-to-treat analysis. The PONV incidence was 61.0% (72/118) in the Control group, 40.2% (47/117) in the Bolus group, and 28.0% (33/118) in the Infusion group. The incidence was significantly lower in the Bolus group than in the Control group (RR 0.66; 95% CI 0.51-0.86; adjusted P = 0.003) and in the Infusion group than in the Control group (RR 0.46; 95% CI 0.33-0.63; adjusted P < 0.001); the difference between the Infusion and Bolus groups was not statistically significant (RR 0.70; 95% CI 0.48-1.00; adjusted P = 0.144). Emergence agitation occurred more frequently in the Bolus group than in the Control group (36.8% [43/117] vs. 21.2% [25/118], adjusted P = 0.027), but did not differ significantly between the Infusion and Control groups.

Conclusions: A low-dose bolus plus continuous infusion of penehyclidine was effective in preventing PONV without increasing emergence agitation.

Trial registration: Clinicaltrials.gov. Identifier: NCT04454866.

Keywords: Bimaxillary surgery; Orthognathic surgery; Penehyclidine; Postoperative nausea and vomiting.

Conflict of interest statement

The authors declare no conflict of interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of the study
Fig. 2
Fig. 2
Forest plot in predefined subgroups. Forest plot assessing the effect of Bolus group vs. Control group (A) and the effect of Infusion group vs. Control group (B) in predefined subgroups. Logistic models were applied for the assessment of treatment-by-covariate interactions. Treatment-by-covariate interactions were adjusted for each subgroup factor, including age, female sex, motion sickness/PONV history, smoking history, use of nitrous oxide, use of sevoflurane, and duration of surgery. PONV, postoperative nausea and vomiting
Fig. 3
Fig. 3
Incidences of PONV (A) and moderate-to-severe nausea (B) during different time periods after surgery. When compared with the Control group, the incidence of PONV was significantly lower in the Bolus group from 0 to 6 h, > 6 to 12 h, and > 12 to 24 h after surgery, and was significantly lower in the Infusion group from > 6 to 12 h, > 12 to 24 h, > 24 to 48 h, and > 48 to 72 h after surgery; when compared with the Bolus group, it was significantly lower in the Infusion group from > 12 to 24 h and > 48 to 72 h after surgery (A). When compared with the Control group, the incidence of moderate-to-severe nausea was significantly lower in the Bolus group from 0 to 6 h and > 6 to 12 h after surgery; when compared with the Bolus group, it was significantly lower in the Infusion group from > 12 to 24 h after surgery (B). P values were adjusted with Bonferroni method. PONV, postoperative nausea and vomiting. Please also see Table A1.

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