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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Gachon University Gil Medical Center
Sponsor:
Information provided by (Responsible Party):
Won-Suk Lee, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01752374
First received: December 16, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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.


Condition
Female Patients Undergoing Laparoscopic Abdominal Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • severity of nasea [ Time Frame: immediated postop to 48hrs after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • frequency of rescue drug needed [ Time Frame: postop to 48hrs after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Palonosetron group
Patient recieving Palonosetron/granisetron and ramosetron
Granisetron group
Ramosetron group

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The sample size was determined based on the ability to detect a difference in the primary outcome variable, the incidence of nausea. With 30 patients in each group there was 80% power at an a of 0.05 to detect a 30% difference in the number of patients with nausea up to 24 h after surgery.

Criteria

Inclusion Criteria:

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

Exclusion criteria included laparoscopic abdominal surgey, allergy to one of the study drugs, opioid dependence, history of gastro-intestinal disease or Parkinson's disease, history of previous PONV and motion sickness, contra-indication for epidural block (previous back surgery, bleeding diathesis or neurological dysfunction), anti-emetic medication within 24 h before surgery, inability to use the PCEA device or comprehend the visual analogue scales (VAS) for pain and nausea assessment, or unwillingness to be enrolled in the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752374

Locations
Korea, Republic of
Won-Suk Lee Recruiting
Incheon, Incehon, Korea, Republic of, 405-760
Contact: Won-Suk Lee, MD    82-32-460-3270    lws@gilhospital.com   
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

Publications:
Responsible Party: Won-Suk Lee, Prof, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01752374     History of Changes
Other Study ID Numbers: GIRBA2493
Study First Received: December 16, 2012
Last Updated: December 16, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Granisetron
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014