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Effects of TIVA With Propofol Versus Inhalational Anaesthesia on Postoperative Pain After Hepatectomy

NCT03597997 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-10-13

No results posted yet for this study

Summary

Propofol is a commonly used intravenous anaesthetic drugs both for induction and maintenance of general anaesthesia. Advantages of total intravenous anaesthesia (TIVA) with propofol include reduced nausea and vomiting, reduced atmospheric pollution, and better wake up profile. But the need for a reliable intravenous access, specialized pumps, pain on injection and potential concerns regarding awareness are potential disadvantages of TIVA propofol.

Results from clinical trials have not been consistent. Some randomized trials have shown improved analgesia with TIVA propofol, and some reported no significant difference. A meta-analysis found that propofol was associated with a statistically significant reduction pain scores 24 hours after surgery. However, the clinical effect size was small. Therefore, the usefulness of propofol as an analgesic adjunct is still inconclusive.

Whether TIVA propofol is useful in providing significant postoperative analgesia may be influenced by the type of surgery and accompanying analgesic regime. This agrees with the concept of procedure specific analgesia. Liver surgery produces moderate to severe pain as a result of an upper abdominal incision. Pain control can be difficult due to concerns with epidural analgesia in patients with potential clotting abnormalities and the effect of analgesic metabolism as a in patients with liver dysfunction. Results from our retrospective study showed that TIVA propofol was associated with reduced pain scores with coughing on postoperative days 1 and 2, and also reduced opioid consumption when compared with sevoflurane after liver surgery.

In this study, the investigators plan to conduct a randomized controlled trial to further determine whether TIVA propofol reduces acute postoperative pain and opioid consumption after hepatectomy.

Conditions

  • Postoperative Pain

Interventions

DRUG

Propofol

Target controlled infusion (TCI) with modified Marsh effect site model (Fresenius Kabi) will be used for induction and maintenance of general anaesthesia. Monitoring and other anaesthetic procedures including the management of hypertension and hypotension in group P will be the same as group S. The only difference is that induction and maintenance of general anaesthesia will be conducted using total intravenous infusion of propofol. Oxygen and air would be given to provide a FiO2 of 30-50%.

DRUG

Sevoflurane

Propofol 1.5-3mg/kg, remifentanil 1mcg/kg, and rocuronium 0.6-1mg/kg or atracurium 0.5mg/kg will be used intravenously for induction of general anaesthesia. Intubation would be performed after induction of general anaesthesia. General anaesthesia monitoring will be used. Sevoflurane, air and oxygen will be used for maintenance of general anaesthesia. FiO2 will be kept between 35-50%. BIS monitoring will be applied and level of anaesthetia will be titrated to maintain a BIS value of between 40-60. Intravenous remifentanil infusion between 0.1-0.2 mcg/kg/min will be given and this will be titrated to provide optimal haemodynamic parameters.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Stanley SC Wong, MBBS · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-27
Primary Completion
2021-07-15
Completion
2021-12-01

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03597997 on ClinicalTrials.gov