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Randomized Controlled Trial
. 2023 Apr 24;23(1):135.
doi: 10.1186/s12871-023-02078-0.

Penehyclidine hydrochloride for treating postoperative nausea and vomiting after laparoscopic bariatric surgery: a double-blinded randomized controlled trial

Xiahao Ding #  1 , Dapeng Chen #  1 , Jinxing Che  1   2 , Siyang Xu  1   3 , Hui Liang  4 , Bo Gui  5
Affiliations
Randomized Controlled Trial

Penehyclidine hydrochloride for treating postoperative nausea and vomiting after laparoscopic bariatric surgery: a double-blinded randomized controlled trial

Xiahao Ding et al. BMC Anesthesiol. .

Abstract

Background: Postoperative nausea and vomiting (PONV) is a common and distressing complication of laparoscopic bariatric surgery (LBS). Penehyclidine hydrochloride has been reported to be effective in preventing PONV. Considering the potential preventive effects of penehyclidine against PONV, we hypothesized that intravenous infusion of penehyclidine may alleviate PONV within the first 48 h in patients scheduled for LBS.

Methods: Patients who underwent LBS were randomly assigned (1:2) to receive saline (Control group, n = 113) or a single intravenous dose of penehyclidine 0.5 mg (PHC group, n = 221). The primary outcome was incidence of PONV within the first 48 h postoperatively. Secondary endpoints included severity of PONV, need for rescue antiemetic therapy, volume of water intake, and time to first flatus.

Results: PONV occurred in 159 (48%) patients within the first 48 h postoperatively, including 51% in the Control group and 46% in the PHC group. There was no significant difference in the incidence or severity of PONV between the two groups (P > 0.05). Within the first 24 h and 24-48 h, no significant difference was found in incidence or severity of PONV, postoperative nausea, postoperative vomiting, need for rescue antiemetic therapy, or volume of water intake (P > 0.05). Kaplan-Meier curves showed that penehyclidine was significantly associated with a prolonged time to first flatus (median onset time: 22 h vs. 21 h, P = 0.036).

Conclusions: Penehyclidine did not decrease incidence and severity of PONV in patients undergoing LBS. However, a single intravenous dose of penehyclidine (0.5 mg) was associated with a slightly prolonged time to first flatus.

Trial registration: Chinese Clinical Trial Registry (ChiCTR2100052418, http://www.chictr.org.cn/showprojen.aspx?proj=134893 , date of registration: 25/10/2021).

Keywords: Laparoscopic bariatric surgery; Penehyclidine hydrochloride; Postoperative nausea and vomiting; Time to first flatus.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of patients enrolled in the study. ICU intensive care units, PHC penehyclidine hydrochloride
Fig. 2
Fig. 2
Stacked bar charts showing the severity of PONV (A), PON (B), and POV (C) within 48 h postoperatively between the two groups. The severity of PONV was evaluated as follows: I = no nausea or vomiting, II = nausea but no vomiting, III = mild to moderate vomiting, and IV = severe and frequent vomiting more than five times within 24 h. The severity of PON was evaluated as follows: I = mild, II = moderate, III = severe. The severity of POV was evaluated as follows: I = no vomiting, II = vomiting episodes occurring 1–2 times within 24 h, III = vomiting episodes occurring 3–5 times within 24 h, IV = vomiting episodes occurring > 5 times within 24 h. PONV postoperative nausea and vomiting, PON postoperative nausea, POV postoperative vomiting
Fig. 3
Fig. 3
Kaplan-Meier curves of the time to first flatus postoperatively between the two groups. CON control; PHC penehyclidine hydrochloride
See this image and copyright information in PMC

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