Dataset Information

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

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.

SUBMITTER: Wang LK

PROVIDER: S-EPMC8807454 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Wang Li-Kuan LK Cheng Tong T Yang Xu-Dong XD Xiong Guo-Li GL Li Nan N Wang Dong-Xin DX

Journal of anesthesia 20211105 1

<h4>Purpose</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 34738161

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Project description:Postoperative nausea and vomiting (PONV) is one of the most common adverse outcomes after strabismus surgery. The primary outcome of this prospective, randomized, double-blind study was to compare the incidences of nausea or vomiting, and patient satisfaction of ondansetron and ramosetron after strabismus surgery under general anesthesia. The secondary outcome was to investigate whether the number of involved extraocular muscles (EOMs) in strabismus surgery was related to PONV.One hundred and five patients (aged 18-60 years) undergoing strabismus surgery were allocated randomly to one of the three groups: placebo, ondansetron, or ramosetron. Patients received 2 ml placebo, 4 mg ondansetron, or 0.3 mg ramosetron at the end of surgery. Each of the three groups was subdivided into two subgroups according to the number of EOMs involved in the surgery: subgroup S, single-muscle correction; subgroup M, multiple-muscle correction. The incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as primary outcome. With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as seconadary outcome.The incidence of nausea was significantly lower in the ramosetron group at 2 h (9.4 %) than in the placebo (45.2 %) and ondansetron (34.7 %) groups (P < 0.05). The incidence of nausea was also significantly lower in the ramosetron group at 24 h than in the other groups (P < 0.05). Patients in the ramosetron group were more satisfied at 2 h (8.11 ± 0.98) and 24 h (8.50 ± 0.67) after surgery than those in the other groups (P < 0.05). With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, there were no significant differences in either the incidence of nausea or patient satisfaction.Ramosetron has superior antiemetic activity to ondansetron in adult strabismus surgery patients. The number of EOMs involved in strabismus surgery was not related to the incidence of PONV.Clinical Research Information Service (CRiS) Identifier: KCT0000688 . Date of registration: 27 February 2013.

Dataset Information

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

Purpose

Methods

Results

Conclusions

Trial registration

Publications

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

Similar Datasets

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