Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00613

2 Trial Registration Date

2018-07-04

i Registration Status

Prospective

3 Secondary IDs

N/A

4 Source(s) of Funding

Departmental resources

5 Primary Sponsor

Departmental resources

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Dr Wong Tak-Kin

ii Address

Tuen Mun Hospital

iii Phone

24685111

iv Email

wtk635@ha.org.hk

v Affiliation

Department of Anaesthesia and Intensive Care, Tuen Mun Hospital

vi Country

Hong Kong SAR China

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

i Name

Tak Kin Wong

ii Address

Tuen Mun Hospital

iii Phone

96214286

iv Email

wtk635@ha.org.hk

v Affiliation

Department of Anaesthesia and Intensive Care, Tuen Mun Hospital

vi Country

Hong Kong SAR China

9 Official Scientific Title of the Study

Randomized controlled trial on qNOX guidance vs Shafer's pharmacokinetics model in fentanyl-based analgesia during liver resection

10 Public Title

Randomized controlled trial on qNOX guidance vs Shafer's pharmacokinetics model in fentanyl-based analgesia during liver resection

i Public Title in Chinese 研究名稱

qNOX疼痛指數相對於以藥物動力學作為引導肝臟切除手術期間芬太尼(Fentanyl)劑量的隨機對照試驗

11 Short Title (Optional)

qNOX 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?

2018-06-05

iii Full Name of IRB/IEC

New Territories West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

NTWC/CREC/17032

14 Medical Condition Being Studied

Pain

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Use of qNOX index to guide the pain management using fentanyl during liver surgery

iii Dosage form of the intervention

Guided by qNOX index

iv Dosage of the intervention

• Further dose of fentanyl at 20mcg/bolus will be given when qNOX index >50 at 5-minute interval until: • the hourly limit of 5-3-2-1 fentanyl regime has been reached (*induction dose will be included) OR • general anesthesia has been reversed, i.e. qCON>60.

v Duration of the intervention

During the operation

vi Frequency of the intervention

Every 5-min during operation

16 Comparative Treatments

i Description/ name of comparative treatments

Use of Shafer’s Pharmacokinetic model to guide the pain management using fentanyl during liver surgery

ii Dosage form of the comparative treatments

Guided by Shager’s pharmacokinetic model

iii Dosage of the comparative treatments

-3-2-1 fentanyl dosing regimen according to Shafer’s normogram will be given to maintain a target plasma concentration of fentanyl at 2ng/ml

iv Duration of the comparative treatments

During operation

v Frequency of the comparative treatments

Hourly

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients scheduled for elective liver surgery

ASA I to III

Age between 18-80 years old

ii Exclusion Criteria

Laparoscopic surgery

Concomitant non-hepatobiliary surgery

Drug allergy to fentanyl/local anesthetic agents

Anticipated operative duration less than 90min

Chronic pain patients

Preoperative opioid consumption

Patients with obstructive sleep apnea

Psychiatric disorders

Inability to use PCA device

Severe Chronic Obstructive Airway Disease

Perioperative massive bleeding with hemodynamic instability

History of severe postoperative nausea and vomiting

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

Simple computer randomization

ii Nature of control

Historical control

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

N/A

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-08-15

21 Target Sample Size

88

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Total dose of fentanyl administered intraoepratively

ii The metric or method of measurement used

Dose in mcg/kg/hr

iii The timepoint(s) of primary interest

From induction to reversal of general anaesthesia

24 Secondary Outcome

i The Name of the outcome

Time to first analgesic demand at RR

ii The metric or method of measurement used

From arrival at recovery room to patient’s first analgesic demand

iii The timepoint(s) of primary interest

Secondary Outcome

i The Name of the outcome

Total dose of rescue fentanyl given at RR

ii The metric or method of measurement used

Total dose of rescue fentanyl given at RR

iii The timepoint(s) of primary interest

During recovery stay

Secondary Outcome

i The Name of the outcome

Sedation score at RR

ii The metric or method of measurement used

Sedation score at RR

iii The timepoint(s) of primary interest

Whole recovery stay

Secondary Outcome

i The Name of the outcome

VAS for analgesia at rest and during cough, sedation, nausea and pruritus at RR and during the first 24 hours postoperatively

ii The metric or method of measurement used

VAS for analgesia at rest and during cough, sedation, nausea and pruritus

iii The timepoint(s) of primary interest

First 24 hours postoperatively

Secondary Outcome

i The Name of the outcome

Total PCA fentanyl consumption within the first 24 hours postoperatively

ii The metric or method of measurement used

Total PCA fentanyl consumption

iii The timepoint(s) of primary interest

Secondary Outcome

i The Name of the outcome

No of patients requiring naloxone for opioid overdose

ii The metric or method of measurement used

No of patient requiring Naloxone

iii The timepoint(s) of primary interest

During study period

Secondary Outcome

i The Name of the outcome

Total doses of naloxone given for opioid overdose

ii The metric or method of measurement used

Total doses of naloxone given for opioid overdose

iii The timepoint(s) of primary interest

During recovery stay

Secondary Outcome

i The Name of the outcome

No of patients requiring antiemetic for PONV

ii The metric or method of measurement used

No of patients requiring antiemetic for PONV

iii The timepoint(s) of primary interest

During recovery stay

Secondary Outcome

i The Name of the outcome

Chronic pain assessment at 3-month postoperative interval

ii The metric or method of measurement used

Chronic pain assessment

iii The timepoint(s) of primary interest

At 3-month postoperative interval

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2019-08-09

27 Primary Registry and Trial Identifying Number

ChiCTR1800017011

28 Date of Registration in Primary Registry

2018-07-04

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Trial Detail