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Impact of an Optimised Monitored Anesthesia on the Patients' Recovery After Cytoreduction Surgery Plus HIPEC

NCT04104334 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-10-08

No results posted yet for this study

Summary

The objective of our PILOT study is to evaluate the impact of a controlled (monitored) randomized anesthesia during cytoreductive surgery with HIPEC to oxaliplatin in order to treat adenocarcinomas of colorectal origin. The combination of NOL monitoring, BIS monitoring and continuous hemodynamic monitoring (FloTrac EV1000 system) can improve patient safety by reducing the length of hospital stay by decreasing total hypnotic doses and intraoperative opioids and side effects following anesthesia.

Conditions

  • Hyperthermia
  • Colorectal Neoplasms
  • Oxaliplatin

Interventions

DRUG

Remifentanil infusion, desflurane titration and fluid infusion will be guided by NOL index, BIS index and Flotrac EV1000 system respectively

NOL index will guide the administration of remifentanil to keep the index between 5-25, and the desflurane will be titrated to keep a BIS index between 45 and 55. Cardiac output and stroke volume variation will be measured by the Flotrac EV1000 system. Patients will receive 250ml fluid challenges with a recommended solution as required, in order to achieve a maximal value of stroke volume

DRUG

Remifentanil infusion and desflurane titration will be guided by anesthesia usual practices

Desflurane will be administered to keep MAC at 1, and remifentanil infusion rate will be adapted to the mean arterial blood pressure to keep it between 65 and 100, according to anesthesia usual practices

Sponsors & Collaborators

  • Ciusss de L'Est de l'Île de Montréal

    lead OTHER

Principal Investigators

  • Philippe PR Richebé, MD PhD · CIUSSS Est de l'île de Montréal

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-08
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Canada

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 NCT04104334 on ClinicalTrials.gov