NoL and BIS Monitoring on Patients Recovery and Safety After Surgery

Not Applicable

• Conditions: Anesthesia; Pain
• Interventions: Device: BIS index/NoL index; Device: Variation of baseline mean arterial pressure

• Registration Number: NCT03410485
• Lead Sponsor: Maisonneuve-Rosemont Hospital

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.

Detailed Description

Hypothesis is that the intraoperative use of the combination of 1) the NoL index (given by the PMD200TM monitor, Medasense LTD inc, Ramat, Israel) to monitor pain levels and to guide opioids' administration during surgery, and 2) the BIS index (Medtronic, St-Laurent, QC, Canada) to monitor the depth of hypnosis during anesthesia and to guide the administration of anesthetic halogenous gases, will improve the quality of recovery as well as the safety after anesthesia in ERAS (Early Rehabilitation After Surgery) patients undergoing colonic surgery under general anesthesia + epidural analgesia.

This study will compare a group of patients monitored by the classical monitoring (with anesthesia/analgesia guided by these classical parameters: heart rate, blood pressure; Control "C" group; no BIS, no NoL) to a group of patients monitored by the same classical monitoring implemented with the NoL/BIS indices (with analgesia/anesthesia guided by these 2 indices; Monitoring "M" group).

The primary objective of the study will be the total consumption of desflurane that is expected to be significantly reduced in the M group. Secondary objectives will be evaluating safety and side effects of anesthesia and opioids and we expect a reduction of the following parameters: time for awakening from anesthesia, time for extubation, time for transfer to PACU, intraoperative opioid consumption, opioid consumption in PACU and for 48h, time for readiness for discharge from PACU, incidence of adverse effects such as: nausea-vomiting / sedation / respiratory depression / itching / dizziness / cognitive dysfunction in PACU and for 48h, satisfaction of the patients at 24 and 48hs, pain scores at rest and at mobilization in PACU, at 24h and 48h. Quality of postoperative recovery after surgery and treatment satisfaction are also expected to be higher in the M group than in the C group.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-11
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-18
• Last Update Submitted: 2018-01-18
• Study First Posted: 2018-01-25
• Last Update Posted: 2018-01-25
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monitoring (M Group )	BIS index/NoL index	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).
Control (C Group )	Variation of baseline mean arterial pressure	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.

Primary Outcome Measures

Name	Time	Method
Total desflurane consumption	10 hours	Total consumption and absorption in ml/kg/h of desflurane in group C versus group M

Secondary Outcome Measures

Name	Time	Method
Hourly desflurane consumption	10 hours	Consumption and absorption of desflurane in ml/kg/h for each hour of surgery. These data are given by the Drager Perseus A500 ventilator per second during the surgery.
Total phenylephrine consumption mcg/h	10 hours	Total doses of intraoperative infused i.v. phenylephrine and doses per hour
PACU discharge time in minutes	3 hours	Time for readiness for PACU discharge based on Aldrete scores superior to 9.
Postoperative chronic pain (score 0 to 10)	6 months postoperatively	Presence and severity of persistent postoperative pain with DN4 questionnaires
Postoperative cognitive dysfunction	5 days postoperatively	Assessment of perioperative cognitive function using the classical MMSE scores over 5 days
Postoperative analgesia hydromorphone rescue	5 days postoperatively	Total hydromorphone rescue doses for 5 days, and total epidural doses in ml as continuous infusion + boluses (PCEA)
POCD/POD related inflammatory cytokines	24h postoperatively	Blood sample will be drawn and cytokines related to POCD/POD will be measured
Total remifentanil consumption mcg/h	10 hours	Total consumption of i.v. remifentanil during surgery and for each hour of surgery
Acute pain (NRS scores on scale from 0 to 10)	48 hours postoperatively	NRS scale pain score at rest
Readmission	6 months postoperatively	Rate of hospital readmission up to 6 months following surgery
Emergence time (seconds)	30 min	Time for awakening (eyes opening) at the end of the surgery, time for extubation, time for transfer to the PACU in seconds
Postoperative delirium	5 days postoperatively	Assessment of perioperative Delirium with NuDESC score over 5 days after surgery
Recovery after surgery score on scale QOR15 (scale 0 to 150)	5 days postoperatively	Patients' perceived quality of recovery from anesthesia with QoR-15
Postoperative chronic pain (scale 0 to 60)	6 months postoperatively	Presence and severity of persistent postoperative pain SF-MPQ questionnaires
Analgesic requirement (total ml of epidural solution consumption)	48 hours postoperatively	cumulative dose over 48hs
Nausea and vomiting	48 hours postoperatively	on Nausea and vomiting scale from 0 to 4, cumulative scores over 48hours
Mortality	6 months postoperatively	Rate of hospital mortality up to 6 months following surgery
Hypotensive events	10 hours	Total number of hypotensive events during surgery defined as mean blood pressure below 10% of baseline
Postoperative sedation	48 hours postoperatively	On POSS (postoperative sedation score) scale from 0 to 5, cumulative over 48 hours
Postoperative respiratory depression	48 hours postoperatively	yes or no (1 or 0) for 48 hours

Trial Locations

Locations (1)

Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal; 🇨🇦 Montreal, Quebec, Canada