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

This study has been completed.
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: August 28, 2015
Last verified: August 2015
  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 ]

Enrollment: 90
Study Start Date: December 2011
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   (Adult, Senior)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01752374

Locations
Korea, Republic of
Won-Suk Lee
Incheon, Incehon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: August 28, 2015
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 22, 2016