The Effect of Glycyrrhizin on the Occurrence of Postoperative Nausea and Vomiting

Not Applicable

Completed

• Conditions: Postoperative Nausea
• Interventions: Drug: Ammonium Glycyrrhizinate

• Registration Number: NCT04742660
• Lead Sponsor: Konkuk University Medical Center

Brief Summary

The investigators investigate the association between the administration of glycyrrhizin during induction of general anesthesia and the occurrence of postoperative nausea and vomiting (PONV) in patients undergo breast surgery

Detailed Description

Postoperative nausea and vomiting (PONV) is one of a common complication after general anesthesia with 30-50% of incidence, increased up to 80% in high risk group. The risk factors of PONV include women population, the previous history of PONV, motion sickness in usual life, non-smoker, exposure to inhalants, perioperative opioid and laparoscopic surgery. Women population is a strong risk factor of PONV. Although perioperative management of PONV based on a guideline has been done in a lot of medical centers worldwide, the incidence of PONV is still reported relatively high.

The main ingredient of Glycyrrhizin is liquorice which has been used as antispasmodics, antiemetics or treatment for gastric ulcer in oriental medicine. Utilizing these effects of liquorice, the investigators investigate whether the addition of glycyrrhzin to conventional antiemetics is effective to decrease the incidence of PONV and improvement of severity of PONV.

Study Timeline

• Study First Submitted: 2021-02-03
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-08
• Study Start: 2021-05-11
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-10
• Status Verified: 2022-05
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

Inclusion Criteria

• participants scheduled to undergo breast surgery aged 20 and above

Exclusion Criteria

• aldosteronism
• electrolyte imbalance
• myopathies
• drug addiction or suspected
• bowel disease
• allergy to drugs
• smoker
• taking any medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group R	Ammonium Glycyrrhizinate	Participants are administered a dose of 0.3mg of ramosetron (conventional antiemetics) intravenously followed by continuous infusion of 120mL normal saline at a rate of 10mL/min.
group G	Ammonium Glycyrrhizinate	participants are administered a dose of 0.3mg of ramosetron followed by continuous infusion of mixture of 20mL glycyrrhizin and 100mL normal saline (total 120mL) at a rate of 10mL/min.

Primary Outcome Measures

Name	Time	Method
the incidence of postoperative nausea and vomiting (PONV)	up to 24 hours after discharge from postanesthetic care unit (PACU)	assessing the incidence of postoperative nausea and vomiting with ordinal scale (0=none, 1=nausea, 2=retching, 3= vomiting)

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Seoul-T'ǔkpyǒlshi, Korea, Republic of