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Trial Detail

CUHK_CCRB00613

2018-07-04

Prospective

N/A

Departmental resources

Departmental resources

N/A

Not Applicable

Dr Wong Tak-Kin

Tuen Mun Hospital

24685111

wtk635@ha.org.hk

Department of Anaesthesia and Intensive Care, Tuen Mun Hospital

Hong Kong SAR China

Tak Kin Wong

Tuen Mun Hospital

96214286

wtk635@ha.org.hk

Department of Anaesthesia and Intensive Care, Tuen Mun Hospital

Hong Kong SAR China

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

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

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

qNOX Study

Hong Kong

Yes

2018-06-05

New Territories West Cluster Research Ethics Committee

NTWC/CREC/17032

Pain

Device

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

Guided by qNOX index

• 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.

During the operation

Every 5-min during operation

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

Guided by Shager’s pharmacokinetic model

-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

During operation

Hourly

Patients scheduled for elective liver surgery

ASA I to III

Age between 18-80 years old

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

18

80

Both Male and Female

Interventional

Randomized

Simple computer randomization

Historical control

Single-blind

Trial subjects

Parallel

Other

N/A

2018-08-15

88

Recruiting

Total dose of fentanyl administered intraoepratively

Dose in mcg/kg/hr

From induction to reversal of general anaesthesia

Time to first analgesic demand at RR

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

Total dose of rescue fentanyl given at RR

Total dose of rescue fentanyl given at RR

During recovery stay

Sedation score at RR

Sedation score at RR

Whole recovery stay

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

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

First 24 hours postoperatively

Total PCA fentanyl consumption within the first 24 hours postoperatively

Total PCA fentanyl consumption

No of patients requiring naloxone for opioid overdose

No of patient requiring Naloxone

During study period

Total doses of naloxone given for opioid overdose

Total doses of naloxone given for opioid overdose

During recovery stay

No of patients requiring antiemetic for PONV

No of patients requiring antiemetic for PONV

During recovery stay

Chronic pain assessment at 3-month postoperative interval

Chronic pain assessment

At 3-month postoperative interval

No

2019-08-09

ChiCTR1800017011

2018-07-04

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