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

C

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

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

Trial contacts and locations

1

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Central trial contact

Dagang Wang, MD; Guangyou Duan, MD

Data sourced from clinicaltrials.gov

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