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
About this trial
This is an interventional prevention trial for Postoperative Nausea
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
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
NCT ID
NCT04742660
First Posted
February 3, 2021
Last Updated
May 12, 2022
Sponsor
Konkuk University Medical Center
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
We'll reach out to this number within 24 hrs