PainCINAAMONNCT03410485
NoL and BIS Monitoring on Patients Recovery and Safety After Surgery
A study testing BIS index/NoL index and Variation of baseline mean arterial pressure in people with Pain and Anesthesia, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Anesthesia
- What is being tested?
- BIS index/NoL index and Variation of baseline mean arterial pressure
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montreal
Montreal, Quebec, H1T2M4
Nadia Godin, RN, 514-252-3400 ext. 3193, ngodin.hmr@ssss.gouv.qc.ca
Philippe Richebe, MD PhD, 514-252-3400 ext. 4620, philipperichebe@live.com
About this study
Official title: Evaluation of the Combined Intraoperative Depth of Analgesia (NoL) and Depth of Anesthesia (BIS) Monitoring on the Patients' Recovery and Safety After Surgery: A Pilot Study
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.
Read the 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.
- Conditions
- Pain, Anesthesia
- Being tested
- BIS index/NoL index, Variation of baseline mean arterial pressure
- Keywords
- NoL index, Bispectral index, Intraoperative monitoring
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS index/NoL indexDevice
Also called PMD200, Bispectral 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: BIS index/NoL index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total desflurane consumption
Total consumption and absorption in ml/kg/h of desflurane in group C versus group M
Measured: 10 hours
Secondary outcomes (20)
Hourly desflurane consumption
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.
Measured: 10 hours
Total remifentanil consumption mcg/h
Total consumption of i.v. remifentanil during surgery and for each hour of surgery
Measured: 10 hours
Hypotensive events
Total number of hypotensive events during surgery defined as mean blood pressure below 10% of baseline
Measured: 10 hours
Total phenylephrine consumption mcg/h
Total doses of intraoperative infused i.v. phenylephrine and doses per hour
Measured: 10 hours
Emergence time (seconds)
Time for awakening (eyes opening) at the end of the surgery, time for extubation, time for transfer to the PACU in seconds
Measured: 30 min
Acute pain (NRS scores on scale from 0 to 10)
NRS scale pain score at rest
Measured: 48 hours postoperatively
Analgesic requirement (total ml of epidural solution consumption)
cumulative dose over 48hs
Measured: 48 hours postoperatively
Nausea and vomiting
on Nausea and vomiting scale from 0 to 4, cumulative scores over 48hours
Measured: 48 hours postoperatively
Postoperative sedation
On POSS (postoperative sedation score) scale from 0 to 5, cumulative over 48 hours
Measured: 48 hours postoperatively
Postoperative respiratory depression
yes or no (1 or 0) for 48 hours
Measured: 48 hours postoperatively
PACU discharge time in minutes
Time for readiness for PACU discharge based on Aldrete scores superior to 9.
Measured: 3 hours
Postoperative cognitive dysfunction
Assessment of perioperative cognitive function using the classical MMSE scores over 5 days
Measured: 5 days postoperatively
Postoperative delirium
Assessment of perioperative Delirium with NuDESC score over 5 days after surgery
Measured: 5 days postoperatively
Postoperative analgesia hydromorphone rescue
Total hydromorphone rescue doses for 5 days, and total epidural doses in ml as continuous infusion + boluses (PCEA)
Measured: 5 days postoperatively
Recovery after surgery score on scale QOR15 (scale 0 to 150)
Patients' perceived quality of recovery from anesthesia with QoR-15
Measured: 5 days postoperatively
Postoperative chronic pain (score 0 to 10)
Presence and severity of persistent postoperative pain with DN4 questionnaires
Measured: 6 months postoperatively
Postoperative chronic pain (scale 0 to 60)
Presence and severity of persistent postoperative pain SF-MPQ questionnaires
Measured: 6 months postoperatively
Mortality
Rate of hospital mortality up to 6 months following surgery
Measured: 6 months postoperatively
Readmission
Rate of hospital readmission up to 6 months following surgery
Measured: 6 months postoperatively
POCD/POD related inflammatory cytokines
Blood sample will be drawn and cytokines related to POCD/POD will be measured
Measured: 24h postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study startOct 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, Medasense Biometrics Ltd
- Responsible party
- Principal investigator, Philippe Richebé, Maisonneuve-Rosemont Hospital
- Investigators
- Philippe Richebé, Md, PhD, Principal investigator, Full Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410485
- Sponsor's protocol ID
- CER15083
- Other IDs
- CAS-2016-010
- Acronym
- CINAAMON
- Status last verified
- Jan 2018
- First submitted
- 11 Oct 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Combined Intraoperative Depth of Analgesia (NoL) and Depth of Anesthesia (BIS) Monitoring on the Patients' Recovery and Safety After Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT03410485
- Acronym / sponsor ID
- CINAAMON / CER15083
- Conditions
- Pain, Anesthesia
- Keywords
- NoL index, Bispectral index, Intraoperative monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Canadian Anesthesiologists' Society, Medasense Biometrics Ltd
- Study start
- Oct 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (C Group ) | Active comparator | Device: Variation of baseline mean arterial pressureIntervention 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. |
| Monitoring (M Group ) | Experimental | Device: BIS index/NoL indexIntervention 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS index/NoL indexAlso: PMD200, Bispectral indexRemifentanil 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. | Device | Monitoring (M Group ) |
| Variation of baseline mean arterial pressureRemifentanil 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. | Device | Control (C Group ) |
Primary outcome
Total desflurane consumption
Time frame: 10 hours
Total consumption and absorption in ml/kg/h of desflurane in group C versus group M
20 secondary outcomes
Hourly desflurane consumption
Time frame: 10 hours
Total remifentanil consumption mcg/h
Time frame: 10 hours
Hypotensive events
Time frame: 10 hours
Total phenylephrine consumption mcg/h
Time frame: 10 hours
Emergence time (seconds)
Time frame: 30 min
Acute pain (NRS scores on scale from 0 to 10)
Time frame: 48 hours postoperatively
Analgesic requirement (total ml of epidural solution consumption)
Time frame: 48 hours postoperatively
Nausea and vomiting
Time frame: 48 hours postoperatively
Postoperative sedation
Time frame: 48 hours postoperatively
Postoperative respiratory depression
Time frame: 48 hours postoperatively
PACU discharge time in minutes
Time frame: 3 hours
Postoperative cognitive dysfunction
Time frame: 5 days postoperatively
Postoperative delirium
Time frame: 5 days postoperatively
Postoperative analgesia hydromorphone rescue
Time frame: 5 days postoperatively
Recovery after surgery score on scale QOR15 (scale 0 to 150)
Time frame: 5 days postoperatively
Postoperative chronic pain (score 0 to 10)
Time frame: 6 months postoperatively
Postoperative chronic pain (scale 0 to 60)
Time frame: 6 months postoperatively
Mortality
Time frame: 6 months postoperatively
Readmission
Time frame: 6 months postoperatively
POCD/POD related inflammatory cytokines
Time frame: 24h postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Richebé, Md, PhD principal investigator
Full Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS index/NoL index and Variation of baseline mean arterial pressure in people with Pain and Anesthesia, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Richebé, MD, PhD (+1-514-743-6558, philipperichebe@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total desflurane consumption (time frame: 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.