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Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01543945
First Posted: March 5, 2012
Last Update Posted: July 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thanyamon Asampinwat, Prince of Songkla University
  Purpose
The purpose of this study is to compare the incidence of Postoperative nausea and vomiting between the intervention group who received multimodal antiemetic management and the control group who did not get this protocol.

Condition Intervention Phase
Postoperative Nausea and Vomiting Drug: Dexamethasone Drug: Ondansetron Drug: Dimenhydrinate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Thanyamon Asampinwat, Prince of Songkla University:

Primary Outcome Measures:
  • Incidence of PONV in ambulatory gynecologic laparoscopy [ Time Frame: four year ]

Enrollment: 340
Study Start Date: March 2008
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multimodal antiemetic management group
Multimodal antiemetic group : Low risk :no PONV prophylaxis moderate risk : ondansetron 4 mg iv high risk : dexamethasone 4 mg + ondansetron 4 mg Extremely high risk : dexamethasone 4 mg + ondansetron 4 mg + dimenhydrinate 1 mg
Drug: Dexamethasone
4 mg iv before induction for high and extremely high risk
Other Names:
  • Multimodal antiemetic group :
  • high risk : dexamethasone 4 mg + ondansetron 4 mg
  • Extremely high risk : dexamethasone 4 mg +
  • ondansetron 4 mg +
  • dimenhydrinate 1 mg
Drug: Ondansetron
4 mg iv before ended surgery 30 min
Drug: Dimenhydrinate
1 mg/kg iv before ended surgery 30 min
Active Comparator: Control group
Control group: Low and moderate risk : no PONV prophylaxis High risk : Ondansetron 4 mg. iv Extremely high risk : Ondansetron 4 mg .iv
Drug: Ondansetron
4 mg iv before ended surgery 30 min

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ambulatory gynecologic laparoscopy
  • Age 18-45 years
  • ASA class 1-2

Exclusion Criteria:

  • The patients who take opioid, steroid, pyschotics or antiemetic drug within 24 hours before surgery
  • History of antiemetic, anesthetic and analgesic drugs allergy
  • Pregnancy or breast feeding
  • Body mass index >34 kg/square metre
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01543945


Locations
Thailand
Anesthesiology Department, Faculty of Medicine, Prince of Songkla University
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Thanyamon Asampinwat, MD Anesthesiology department, Faculty of Medicine, Prince of Songkla University Thailand
  More Information

Responsible Party: Thanyamon Asampinwat, Assistant Professor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01543945     History of Changes
Other Study ID Numbers: PONV9268
First Submitted: February 28, 2012
First Posted: March 5, 2012
Last Update Posted: July 31, 2012
Last Verified: July 2012

Keywords provided by Thanyamon Asampinwat, Prince of Songkla University:
Postoperative Nausea and Vomiting
Ambulatory
Gynecologic laparoscopy
Incidence of postoperative nausea and vomiting.

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Ondansetron
Antiemetics
Dimenhydrinate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents