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NCT01806948 Clinical Trial

Efficacy Study of Antiemetics to Reduce Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01806948
Other study ID # SNUBH_GO_017
Secondary ID
Status Completed
Phase Phase 2
First received March 6, 2013
Last updated January 9, 2015
Start date April 2013
Est. completion date October 2014

Study information
Verified date January 2015
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

We randomized patients who received laparoscopic surgery for benign gynecologic disease into double dose (Experimental Group) or single dose (Control Group) of antiemetics. We compared the degree of postoperative nausea and vomiting in experimental and control groups.

Recruitment information / eligibility
Status Completed
Enrollment 96
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Laparoscopy for benign gynecologic disease

Exclusion Criteria:

- Vomiting within 24 hours before surgery

- Not using patient controlled analgesics postoperatively

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Ramosetron

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Si Gyeonggi Do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete Response Rate The percentage of patients who experienced neither nausea nor vomiting within 24 hours after surgery Postoperative 24 hours No
See also
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Completed NCT02550795 - Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer N/A
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Recruiting NCT01442012 - Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery N/A
Completed NCT01478165 - Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting N/A
Unknown status NCT01268748 - Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain N/A
Completed NCT02143531 - Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting Phase 4
Completed NCT00734929 - Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy Phase 4