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

NCT04104334 | Terminated

• 1 other identifier: 2019-1788
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cytoreduction; HIPEC; Oxaliplatin; Colorectal; Peritoneal; Carcinomatosis; Monitoring; Anesthesia

Outcome Measures

Primary Outcomes (6)

• The hospital length of stay in days

  The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012). After these criteria are achieved, discharge may take place.

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

• Tolerance of oral intake

  The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: \- Tolerance of oral intake. After these criteria are achieved, discharge may take place.

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

• Recovery of lower gastrointestinal function

  The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: \- Recovery of lower gastrointestinal function. After these criteria are achieved, discharge may take place.

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

• Adequate pain control with oral analgesia

  The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: \- Adequate pain control with oral analgesia. After these criteria are achieved, discharge may take place.

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

• Ability to mobilize and self-care

  The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: \- Ability to mobilize and self-care. After these criteria are achieved, discharge may take place.

  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

  The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria. These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include: \- Clinical examination and laboratory tests show no evidence of complications or untreated medical problems. After these criteria are achieved, discharge may take place.

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

Secondary Outcomes (42)

• Intraoperative anesthetic gas' consumption in ml/kg/h

  Intraoperative

• Intraoperative remifentanil consumption in mcg/kg/min

  Intraoperative

• Intraoperative fluid's consumption in ml/h

  Intraoperative

• Intraoperative number of hypotensive events

  Intraoperative

• Intraoperative phenylephrine consumption in mcg/kg/min

  Intraoperative

Study Arms (2)

Monitored group "M" (optimized controlled anesthesia)

ACTIVE COMPARATOR

Patients in the Monitored group "M", the 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, desflurane titration and fluid infusion will be guided by NOL index, BIS index and Flotrac EV1000 system respectively

Control group "C" (standard of care anesthesia)

ACTIVE COMPARATOR

Patients in the Control group "C" will be managed by clinical staff according to usual practice, 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.

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

Interventions

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

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

Also known as: Monitoring group

Monitored group "M" (optimized controlled anesthesia)

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

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

Also known as: Control group

Control group "C" (standard of care anesthesia)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montréal

Montreal East, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Hyperthermia; Colorectal Neoplasms; Carcinoma

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Philippe PR Richebé, MD PhD

  CIUSSS Est de l'île de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization into Monitored group "M" (BIS + NOL + Flotrac EV1000) vs control group "C" (standard of care anesthesia) will be done prior to the entrance in the OR, the day of the surgery.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor, Director of Research, Department of Anesthesiology and Pain Medicine of Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL)

Model Details: 2 groups of patients. Randomization into Monitored group "M" (BIS + NOL + Flotrac EV1000) vs control group "C" (standard of care anesthesia) according to randomization list for a total number of 80 patients.

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: September 26, 2019
• Study Start: May 8, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: October 8, 2021

Record last verified: 2021-09

Locations

CA (1)