Palonestron, Granisetron and Ramosetron for Prevention of Postoperative Nasea and Voming After Laparoscopic Abdominal Surgery

NCT ID: NCT01752374

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31

Brief Summary

We compared the prophylactic anti-emetic efficacy of ramosetron, a newly developed 5-HT3 antagonist, granisetron and ondansetron in patients at high-risk for postoperative nausea and vomiting after laparoscpic abdominal surgery.

This study was conducted to determine the efficacy of three 5-HT3 receptor antagonists in the prevention of PONV for laparoscopic surgery in patients receiving PCA IV.

Detailed Description

Occurrences of nausea and vomiting, the severity of nausea (VAS), rescue antiemetic drug use, and amount of PCEA infusion and rescue pethidine were monitored after the end of surgery during four time periods: 0-2 h; 2-6 h; 6-24 h; and 24-48 h. Nausea was defined as the subjectively unpleasant sensation associated with awareness of the urge to vomit; vomiting included retching (defined as the laboured spastic, rhythmic contraction of the respiratory muscles without the expulsion of the gastric contents) and vomiting (defined as the forceful expulsion of gastric contents from the mouth) [11]. A complete response was defined as no PONV and no need for rescue anti-emetic drug. If two or more episodes of PONV occurred during the study period, a rescue anti-emetic (metoclopramide 10 mg) was given IV. The primary outcome was the incidence of nausea during the study period.

Conditions

Female Patients Undergoing Laparoscopic Abdominal Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Palonosetron group

Patient recieving Palonosetron/granisetron and ramosetron

No interventions assigned to this group

Granisetron group

No interventions assigned to this group

Ramosetron group

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• female gender, non-smoking and use of postoperative opioids undergoing laparocopic abdominal surgery

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gachon University Gil Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Won-Suk Lee

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Won-Suk Lee

Incheon, Incehon, South Korea

Countries

South Korea

References

Yoo JY, Chae YJ, Cho HB, Park KH, Kim JS, Lee SY. Comparison of the incidence of postoperative nausea and vomiting between women undergoing open or robot-assisted thyroidectomy. Surg Endosc. 2013 Apr;27(4):1321-5. doi: 10.1007/s00464-012-2607-7. Epub 2012 Dec 13.

Reference Type: BACKGROUND

PMID: 23239293 (View on PubMed)

Lee WS, Lee KB, Lim S, Chang YG. Comparison of palonosetron, granisetron, and ramosetron for the prevention of postoperative nausea and vomiting after laparoscopic gynecologic surgery: a prospective randomized trial. BMC Anesthesiol. 2015 Sep 3;15:121. doi: 10.1186/s12871-015-0102-0.

Reference Type: DERIVED

PMID: 26335706 (View on PubMed)

Other Identifiers

GIRBA2493

Identifier Type: -

Identifier Source: org_study_id