Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00096

2 Trial Registration Date

2006-01-27

i Registration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

Departmental

5 Primary Sponsor

None

6 Secondary Sponsor

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Matthew Chan

ii Address

iii Phone

Department ofAnaesthesia and Intensive Care

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Matthew Chan

ii Address

iii Phone

Department ofAnaesthesia and Intensive Care

iv Email

mtvchan@cuhk.edu.hk

v Affiliation

vi Country

9 Official Scientific Title of the Study

Combination of Aprepitant and Dexamethasone to Prevent Postoperative Nausea and Vomiting

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-11-01

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Anesthesia

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Aprepitant

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Immediately before induction of anesthesia

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Dexamethasone and a combination of Aprepitant and Dexamethasone

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria: All women (age 18-65 years) undergoing open gynecologic surgery will be eligible Exclusion criteria: (1) Patients had preexisting nausea or vomiting (2) Patients had received opioids or drugs with known antiemetic properties in the 24 hours before surgery. (3) Pregnant patients (4) Patients with history of esophageal reflux, opioid or alcohol abuse.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Factorial

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2006-02-01

21 Target Sample Size

320

22 Recruitment Status

Recruiting

23 Primary Outcome

Complete response (no vomiting, no nausea, no rescue antiemetic)

24 Secondary Outcome

QoR,FLIE questionnaire, Pain and nausea score

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-27

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2006-01-27