Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

Sponsor

Prince of Songkla University (Other)

Overall Status

Completed

CT.gov ID

NCT01543945

Collaborator

(none)

340

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: Dexamethasone Drug: Ondansetron Drug: Dimenhydrinate	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

340 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Incidence of PONV in ambulatory gynecologic laparoscopy [four year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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