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Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thanyamon Asampinwat, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01543945
First received: February 28, 2012
Last updated: July 29, 2012
Last verified: July 2012
History of Changes
  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 Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Incidence of PONV in ambulatory gynecologic laparoscopy [ Time Frame: four year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Thanyamon Asampinwat, Assistant Professor, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01543945     History of Changes
Other Study ID Numbers: PONV9268
Study First Received: February 28, 2012
Last Updated: July 29, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by 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
Antiemetics
Dexamethasone
Dimenhydrinate
Ondansetron
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013