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

The Effect of Administration of Glycyrrhizin During Induction Period on the Occurrence of Postoperative Nausea and Vomiting After Breast Surgery

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

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea
• Intervention / Treatment: Drug: Ammonium Glycyrrhizinate

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 Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul-T'ǔkpyǒlshi
    • Seoul, Seoul-T'ǔkpyǒlshi, Korea, Republic of, 05030
      • Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: group R; 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.	Drug: Ammonium Glycyrrhizinate; In control group, we assess the incidence and severity of PONV when participants are aministered ramosetron and placebo. In intervention group, the outcomes are assessed as a result of administration of ramosetron and glycyrrhizin.; Other Names: glycyrrhizin; gulucolin S
ACTIVE_COMPARATOR: group G; 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.	Drug: Ammonium Glycyrrhizinate; In control group, we assess the incidence and severity of PONV when participants are aministered ramosetron and placebo. In intervention group, the outcomes are assessed as a result of administration of ramosetron and glycyrrhizin.; Other Names: glycyrrhizin; gulucolin S

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center
• Investigators: Study Director: Sung-Hyop Kim, M.D. Ph.D, Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2021
• Primary Completion (ACTUAL): March 8, 2022
• Study Completion (ACTUAL): March 10, 2022

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (ACTUAL): February 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Anti-Inflammatory Agents; Glycyrrhizic Acid
• Other Study ID Numbers: KUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No