Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy

NCT02011659 | Unknown Phase 3 DMC

• 1 other identifier: PONV-NHIS-GYN-001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays.

• Randomized controlled arm : Placebo versus Ramosetron injection
• Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs after surgery

Conditions

Uterine Myoma, Ovary Neoplasm, Adenomyosis

Keywords

Ramosetron, postoperative nausea and vomiting, laparoscopy

Outcome Measures

Primary Outcomes (1)

• Incidence or intensity of PONV

  during postoperative hospital stays (2 days)

Secondary Outcomes (1)

• Adverse reaction associated with Ramosetron injection

  Postoperatvie 7 days (at OPD based)

Study Arms (1)

Ramosetron

ACTIVE COMPARATOR

Drug: Ramosetron

Interventions

Ramosetron DRUG

Ramosetron

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18\< or =, = or \<70 with benign gynecologic disease
• ASA-Class I-II
• No-definite malignancy by US, CT/MRI, CA 125 \< 500IU/ml
• Non-smoker

You may not qualify if:

• Conversion to laparotomy
• Hx of malignancy
• Smoker
• Suspicious malignancy

Sponsors & Collaborators

• National Health Insurance Service Ilsan Hospital: lead

Study Sites (1)

National Health Insurance Service Ilsan Hospital

Goyang-si, 410-719, South Korea

RECRUITING

Related Publications (1)

• Li SC, Wang Y, Choi SJ, Jung YS, Han KH, Chung IB, Lee SH. Scheduled injection of ramosetron for prevention of nausea and vomiting following single-port access total laparoscopic hysterectomy: a prospective randomized study. Obstet Gynecol Sci. 2019 Sep;62(5):344-351. doi: 10.5468/ogs.2019.62.5.344. Epub 2019 Jul 23.

  PMID: 31538078 DERIVED

MeSH Terms

Conditions

Myofibroma; Ovarian Neoplasms; Adenomyosis; Postoperative Nausea and Vomiting; Vomiting

Interventions

ramosetron

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms

Central Study Contacts

San-Hui Lee, M.D.

CONTACT

+82-900-0218; sanaram@naver.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 13, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2015
• Last Updated: December 13, 2013

Record last verified: 2013-12

Locations

KR (1)