Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

Prince of Songkla University

Status and phase: Completed; Phase 2

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Dimenhydrinate; Drug: Dexamethasone; Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT01543945

PONV9268

Details and patient eligibility

About

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.

Enrollment: 340 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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340 participants in 2 patient groups

Multimodal antiemetic management group

Experimental group

Description:

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

Treatment:

Drug: Ondansetron

Drug: Dimenhydrinate

Drug: Dexamethasone

Control group

Active Comparator group

Description:

Control group: Low and moderate risk : no PONV prophylaxis High risk : Ondansetron 4 mg. iv Extremely high risk : Ondansetron 4 mg .iv

Treatment:

Drug: Ondansetron