Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Status and phase: Unknown; Early Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: Sevoflurane+placebo; Drug: Sevoflurane+lidocaine; Drug: TIVA+placebo; Drug: TIVA+lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02786329

53/14.03.2016

Details and patient eligibility

About

Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without lidocaine on postoperative short and long term outcome in patients with colorectal cancer undergoing surgery.

As short term endpoints postoperative pain and opioid consumption, resumption of bowel function, PONV, LOS will be registered.

Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer recurrences incidence and mortality.

Full description

Main goals

1. Comparative evaluation of the incidence of recurrences after TIVA vs sevoflurane anesthesia
2. Evaluation of the effect of lidocaine infusion associated with TIVA/sevoflurane on the incidence of chronic pain and of cancer recurrences and survival.

Secondary objectives

1. Evaluation of the influence of lidocaine on postoperative outcome in patients with colorectal cancer
2. Evaluation of the influence of lidocaine on postoperative inflammatory response
3. Evaluation of the influence of lidocaine on the incidence and severity of postoperative pain and outcome in patients with colorectal cancer

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective surgery

Exclusion criteria

• • persistent chronic pain

  • chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
  • Contraindications for any of the study medications
  • Significant psychiatric disorders (Axa I) (major depression, bipolar disorders, schizophrenia, etc.)
  • Significant hepatic (ALAT and/or ASAT > 2 normal values) or renal (plasma creatinine > 2 mg/dl) disorders
  • Convulsive disorders requiring medication during the last 2 years
  • Planned regional analgesia/anesthesia (spinal or epidural)
  • Corticoid dependent asthma
  • Autoimmune disorders
  • Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
  • Refusal for study participation

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 4 patient groups, including a placebo group

TIVA + lidocaine

Active Comparator group

Description:

TIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion. Interventions: TIVA+lidocaine

Treatment:

Drug: TIVA+lidocaine

TIVA+placebo

Placebo Comparator group

Description:

TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion)

Treatment:

Drug: TIVA+placebo

Sevoflurane+placebo

Placebo Comparator group

Description:

Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo). Intervention: sevoflurane anesthesia +placebo (saline infusion)

Treatment:

Drug: Sevoflurane+placebo

Sevoflurane+lidocaine

Active Comparator group

Description:

Sevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively. Intervention: sevoflurane anesthesia+ lidocaine infusion

Treatment:

Drug: Sevoflurane+lidocaine