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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05331651

Enrollment

480

Registered

2022-04-15

Start date

2022-04-21

Completion date

2023-06-30

Last updated

2024-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

Brief summary

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.

Interventions

DRUGGlycopyrronium in Combination With Tropisetron

Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.

DRUGNormal Saline in Combination With Tropisetron

Normal Saline in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
incidence of postoperative nausea and vomiting	from the ending of surgery to 24 hours after surgery	postoperative nausea and vomiting is recorded according to follow-up visits after surgery

Secondary

Measure	Time frame	Description
intensity of postoperative nausea	from the ending of surgery to 24 hours after surgery	intensity of postoperative nausea is assessed using Numeric Rating Scale (0-10, 0 represents no uncomfortable felling, 10 represents tolerableness)
incidence of postoperative vomiting	from the ending of surgery to 24 hours after surgery	postoperative vomiting is recorded according to follow-up visits after surgery
incidence of intervention requirement for nausea and vomiting	from the ending of surgery to 24 hours after surgery	this event is recorded according to follow-up visits after surgery

Other

Measure	Time frame	Description
Postoperative pain intensity	from the ending of surgery to 24 hours after surgery	Pain intensity is assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain)
Postoperative analgesic requirements	from the ending of surgery to 24 hours after surgery	Analgesic requirements is assessed by recording the volume of patient controlled analgesia pump
degree of satisfaction	from the ending of surgery to 24 hours after surgery	degree of satisfaction is assessed by patient using numerical rating scale (0-10, 0 represents unsatisfactory; 10 represents complete satisfaction)
adverse reaction related to glycopyrronium and ondansetron	from the ending of surgery to 24 hours after surgery	adverse reaction is recorded according to follow-up visits after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026