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

Sponsor
Konkuk University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04742660
Collaborator
(none)
224
Enrollment
1
Location
2
Arms
10
Actual Duration (Months)
22.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Ammonium Glycyrrhizinate
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The anticipants are administered either ramosetron+placebo or ramosetron+glycyrrhizinThe anticipants are administered either ramosetron+placebo or ramosetron+glycyrrhizin
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants are blinded to allocated groups. Outcomes assessors are blinded to which group participants are assigned.
Primary Purpose:
Prevention
Official Title:
The Effect of Administration of Glycyrrhizin During Induction Period on the Occurrence of Postoperative Nausea and Vomiting After Breast Surgery
Actual Study Start Date :
May 11, 2021
Actual Primary Completion Date :
Mar 8, 2022
Actual Study Completion Date :
Mar 10, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Konkuk University Medical Center Seoul Seoul-T'ǔkpyǒlshi Korea, Republic of 05030

    Sponsors and Collaborators

    • Konkuk University Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yea-Ji Lee, clinical assistant professor, Konkuk University Medical Center
    ClinicalTrials.gov Identifier:
    NCT04742660
    Other Study ID Numbers:
    • KUH
    First Posted:
    Feb 8, 2021
    Last Update Posted:
    May 13, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Nausea
    Vomiting
    Postoperative Nausea and Vomiting
    Glycyrrhizic Acid

    Study Results

    No Results Posted as of May 13, 2022