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

NCT04742660 | Completed

• 1 other identifier: KUH
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Nausea

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

group R

PLACEBO COMPARATOR

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

group G

ACTIVE COMPARATOR

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

Interventions

Ammonium Glycyrrhizinate DRUG

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.

Also known as: glycyrrhizin, gulucolin S

group G; group R

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants scheduled to undergo breast surgery aged 20 and above

You may not qualify if:

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

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul-T'ǔkpyǒlshi, 05030, South Korea

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Glycyrrhizic Acid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Sung-Hyop Kim, M.D. Ph.D

  Konkuk University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to allocated groups. Outcomes assessors are blinded to which group participants are assigned.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical assistant professor

Model Details: The anticipants are administered either ramosetron+placebo or ramosetron+glycyrrhizin

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: May 11, 2021
• Primary Completion: March 8, 2022
• Study Completion: March 10, 2022
• Last Updated: October 18, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)