NCT03410485

Brief Summary

So far, only vital signs (mostly, blood pressure and heart rate) helped the anesthesiologist to administer hypnotic agents or analgesics. Many devices have offered pain monitoring for anesthetized patients, the most recent being the PMD200 device and its NoL index. The BIS index is widely used for depth of anesthesia monitoring. The hypothesis of this study is that the intraoperative combination of both the NoL and the BIS indices to guide the delivery of opioids and hypotonics respectively, will improve the quality of recovery as well as the safety after anesthesia in ERAS patients undergoing colonic surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

October 11, 2016

Last Update Submit

January 18, 2018

Conditions

PainAnesthesia

Keywords

NoL indexBispectral indexIntraoperative monitoring

Outcome Measures

Primary Outcomes (1)

  • Total desflurane consumption

    Total consumption and absorption in ml/kg/h of desflurane in group C versus group M

    10 hours

Secondary Outcomes (20)

  • Hourly desflurane consumption

    10 hours

  • Total remifentanil consumption mcg/h

    10 hours

  • Hypotensive events

    10 hours

  • Total phenylephrine consumption mcg/h

    10 hours

  • Emergence time (seconds)

    30 min

  • +15 more secondary outcomes

Study Arms (2)

Control (C Group )

ACTIVE COMPARATOR

Intervention for intraoperative analgesic administration will be based on heart rate and blood pressure variations. Intervention for intraoperative hypnotice/desflurane administration will based on keeping the MAC at 0.8.

Device: Variation of baseline mean arterial pressure

Monitoring (M Group )

EXPERIMENTAL

Intervention for intraoperative analgesic administration will be based on the NOL index (to keep it below 25). Intervention for the desflurane administration will be based on the BIS index (to keep it between 40-60).

Device: BIS index/NoL index

Interventions

BIS index/NoL indexDEVICE

Remifentanil i.v. infusion will be run between 0.03 and 0.15 mcg/kg/min and boluses (0.4mcg/kg) will be given to keep a NoL index between 10-20. Once intubated, the maintenance of anesthesia will be achieved with: desflurane set at 1 MAC to start, then adapted to the BIS between 45-55.

Also known as: PMD200, Bispectral index
Monitoring (M Group )
Variation of baseline mean arterial pressureDEVICE

Remifentanil i.v. infusion will be run between 0.03 and 0.15 mcg/kg/min and boluses (0.4mcg/kg) will be given to keep a baseline mean arterial pressure between 10% of variation. Once intubated, the maintenance of anesthesia will be achieved with: desflurane set at 1 MAC to start, then ajusted to 0.8 MAC.

Control (C Group )

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA status I, II or III
  • Patients aged 18 years
  • Colo-rectal surgery
  • Duration and type of surgery requiring an epidural analgesia via an epidural catheter placed prior the general anesthesia induction and an arterial line placed after induction of general anesthesia (classical management of ERAS program patients in our center)

You may not qualify if:

  • chronic arhythmic condition
  • chronic pain
  • Adverse events prompting termination of protocol:
  • Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
  • Unexpected surgical complications requiring strong haemodynamic support (transfusions, volume challenges, vasopressors, inotropic drugs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Montreal, Quebec, H1T2M4, Canada

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philippe Richebé, Md, PhD

    Full Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Richebé, MD, PhD

CONTACT

+1-514-743-6558philipperichebe@live.com

Nadia Godin, RN

CONTACT

514-252-3400ngodin.hmr@ssss.gouv.qc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor Anesthesiology, MD, PhD

Study Record Dates

First Submitted

October 11, 2016

First Posted

January 25, 2018

Study Start

October 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)