TerminatedNot Applicable

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

Stopped: Change in surgical practice and chemotherapy treatment by the surgery team

Canada9 participantsStarted 2019-05-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA status I, II or III * Patients older than 18 years * HIPEC for bowel surgery with oxaliplatin + dextrose 5% for a duration of 30 min * Duration and type of surgery requiring an epidural analgesia via an epidural catheter placed and tunnelled prior the general anesthesia induction and an arterial line placed after induction of general anesthesia. Exclusion Criteria: * Any allergy to one drug used in our anesthesia or HIPEC protocol * Any contra-indication or patient's refusal for epidural placement * Chronic arrhythmic cardiac conditions * Chronic pain with use of opioids more than 3 times per week for 4 weeks * Bowel occlusion * Physical/mental incapacities * Unexpected difficult airway requesting excessive, possibly painful airway manipulations. * Epidural failure

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The hospital length of stay in days

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days

Tolerance of oral intake

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days

Recovery of lower gastrointestinal function

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days

Adequate pain control with oral analgesia

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days

Ability to mobilize and self-care

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days

Clinical examination and laboratory tests show no evidence of complications or untreated medical problems

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days

Trial details

NCT IDNCT04104334

SponsorCiusss de L'Est de l'Île de Montréal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-30

View on ClinicalTrials.gov More Hyperthermia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

The hospital length of stay in days

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days

Tolerance of oral intake

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days

Recovery of lower gastrointestinal function

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days

Adequate pain control with oral analgesia

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days

Ability to mobilize and self-care

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days

Clinical examination and laboratory tests show no evidence of complications or untreated medical problems

Timeframe: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days