Recruiting

NoL & BIS

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT03410485

Conditions

Pain

Anesthesia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BIS index/NoL index

Variation of baseline mean arterial pressure

Study Details

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.

Conditions

Pain

Anesthesia

Study ID

NCT03410485

Start date

Oct, 2016

Status verified date

Jan, 2018

Completion date

Dec, 2018

Anticipated

Primary completion date

Sep, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control (C Group )

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.

experimental: Monitoring (M Group )

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).

Interventions

BIS index/NoL index

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.

Variation of baseline mean arterial pressure

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.

Primary outcome measure

  • Total desflurane consumption [ Time Frame: 10 hours ]

Central Contacts and Locations

Central contacts

Philippe Richebé, MD, PhD

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

Nadia Godin, RN

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

Locations

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

Recruiting

Montreal, Quebec, Canada, H1T2M4

Contacts

Nadia Godin, RN

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

Philippe Richebe, MD PhD

514-252-3400philipperichebe@live.com

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Jan 25, 2018

Last verified

Jan, 2018

Keywords

  • NoL index
  • Bispectral index
  • Intraoperative monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Maisonneuve-Rosemont Hospital on 2018-01-25.