Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting

Chongqing Medical University

Status and phase: Completed; Phase 4

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Glycopyrronium in Combination With Tropisetron; Drug: Normal Saline in Combination With Tropisetron

Study type: Interventional

Funder types: Other

Identifiers

NCT05331651

Glycopyrronium in anti-PONV

Details and patient eligibility

About

To compare the anti-nausea and vomiting effect between glycopyrronium in combination with tropisetron and normal saline in combination with tropisetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium as adjuvant drug to prevent postoperative nausea and vomiting.

Enrollment: 480 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-cardiac surgery
• American Society of Anesthesiologists classification I-III
• Receive general anesthesia
• Voluntarily receive postoperative intravenous controlled analgesia

Exclusion criteria

• Puerpera or lactation women
• Allergy or existing contraindication to glycopyrronium and tropisetron
• Participate in other clinical drug trials within three months
• Can not follow with the study procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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480 participants in 2 patient groups, including a placebo group

Glycopyrronium in Combination With Tropisetron

Experimental group

Treatment:

Drug: Glycopyrronium in Combination With Tropisetron

Normal Saline in Combination With Tropisetron

Placebo Comparator group

Treatment:

Drug: Normal Saline in Combination With Tropisetron