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

NCT ID: NCT04742660

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2022-03-10

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.

Conditions

Postoperative Nausea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Ammonium Glycyrrhizinate

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Ammonium Glycyrrhizinate

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

glycyrrhizin; gulucolin S

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Konkuk University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yea-Ji Lee

clinical assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung-Hyop Kim, M.D. Ph.D

Role: STUDY_DIRECTOR

Konkuk University Medical Center

Locations

Konkuk University Medical Center

Seoul, Seoul-T'ǔkpyǒlshi, South Korea

Countries

South Korea

Other Identifiers

KUH

Identifier Type: -

Identifier Source: org_study_id