Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00310

2 Trial Registration Date

2011-11-25

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Departmental

5 Primary Sponsor

CUHK

6 Secondary Sponsor

NA

Function

Please specify

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

i Name

Matthew Chan

ii Address

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

2632 2736

iv Email

mtvcahn@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

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

i Name

Matthew Chan

ii Address

Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

2632 2736

iv Email

mtvcahn@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

SMartPilot guided Anesthesia and Recovery Trial (SMART): A Pilot study

10 Public Title

SMART Pilot study

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

SMART Pilot study

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2011-06-20

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

Device

Please specify

ii Description/ name of Intervention/article

SMART Pilot anesthesia advisory system

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

During surgery/anesthesia

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Anesthesia administration guided by using the SMART Pilot advisory system or routine care based on hemodynamic changes

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

1. mentally capable to consent
2. to receive general anesthesia ≥ 2 hours
3. ASA 1-3

ii Exclusion Criteria

1. Surgery that include wake up test
2. Patient with history of drug or alcohol abuse or chronic use of hypnotics or opioid
3. Patient with history of allergy to anesthetic drugs

iii Age Minimum

18

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

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

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2011-12-01

21 Target Sample Size

100

22 Recruitment Status

Unknown

23 Primary Outcome

Rate of change in Quality of recovery score in postoperative interviews and at 30 days after surgery

24 Secondary Outcome

1. Incidence of postoperative complications
2. Patient satisfaction
3. Analgesic and anesthetic consumption
4. Pain score in the postoperative period

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2013-01-17

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001786

28 Date of Registration in Primary Registry

2011-12-12

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2013-01-17