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

Primary Purpose

Postoperative Nausea

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ammonium Glycyrrhizinate
Sponsored by
Konkuk University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Konkuk University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

group R

group G

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
February 3, 2021
Last Updated
May 12, 2022
Sponsor
Konkuk University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04742660
Brief Title
The Effect of Glycyrrhizin on the Occurrence of Postoperative Nausea and Vomiting
Official Title
The Effect of Administration of Glycyrrhizin During Induction Period on the Occurrence of Postoperative Nausea and Vomiting After Breast Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
March 8, 2022 (Actual)
Study Completion Date
March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konkuk University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The anticipants are administered either ramosetron+placebo or ramosetron+glycyrrhizin
Masking
ParticipantOutcomes Assessor
Masking Description
Participants are blinded to allocated groups. Outcomes assessors are blinded to which group participants are assigned.
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group R
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
group G
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ammonium Glycyrrhizinate
Other Intervention Name(s)
glycyrrhizin, gulucolin S
Intervention Description
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.
Primary Outcome Measure Information:
Title
the incidence of postoperative nausea and vomiting (PONV)
Description
assessing the incidence of postoperative nausea and vomiting with ordinal scale (0=none, 1=nausea, 2=retching, 3= vomiting)
Time Frame
up to 24 hours after discharge from postanesthetic care unit (PACU)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Hyop Kim, M.D. Ph.D
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Konkuk University Medical Center
City
Seoul
State/Province
Seoul-T'ǔkpyǒlshi
ZIP/Postal Code
05030
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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