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ANI and NoL Index Variations After Standard Nociceptive Stimulus at 0, 50, 25 % of Inhaled N2O in the Anesthetic Mixture

NCT ID: NCT02701478

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-12-31

Brief Summary

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N2O has been used during general anesthesia (GA) for more than 100 years. It is known to have anesthetic agents sparing effect. But small is know on his real analgesic effect during GA. So far, the only way to monitor pain during GA was based on vital signs that are not specific and not sensitive. Few devices tried to evaluated pain under GA during the last 2 decades. More recently, better devices were proposed such as the Physiodoloris device and the PMD200 device. The first offers an index called ANI based on heart rate variability (HRV) assessment. The second offers the NoL index based on the analysis of 5 parameters. The aim of the present study is to evaluate quantitatively the analgesic index of N2O during GA using the two indices ANI and NoL.

Detailed Description

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Title: Assessment of the intraoperative analgesic effect of 50%/50% Nitrous Oxide / Oxygen inhalation by the pain index ANI following a standardized electrical forearm stimulus in patients undergoing laparotomies under general anesthesia and with an intraoperative active epidural analgesia. Comparison to the new NoL analgesic index.

Objectives: To observe the variations of the intraoperative pain indexes ANI and NoL after a classical and standardized electrical stimulation of the forearm (applied with the commonly used nerve stimulator we use for muscle relaxation monitoring) at different concentrations of inhaled Nitrous Oxide (N2O) (from 0% to 50%, concentrations that are commonly used in daily anesthesia). This will allow a quantification of the analgesic effect of N2O.

Study Design: Prospective, open label, observational and descriptive study Subject Population: Adult patients scheduled to undergo abdominal surgery by laparotomy under general anesthesia with an active intraoperative epidural analgesia Sample Size: 40 patients will be evaluated in this study Study Duration: 1 year Study Center: Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada Adverse Events: None expected

Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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N2O exposure

There is only one arm in this study. All patients under General Anesthesia are exposed to 4 different doses or concentrations of inhaled N2O that is combined with the anesthetic desflurane. Each patient will be submitted to the standard nociceptive stimulus when inhaled N2O is at 0, 50, 25, and finally back to 0%. ANI and NoL Indices variations between "before stimulus" and "after stimulus" at each N2O concentration will be assessed and compared. This will allow to demonstrate an analgesic effect (less variations of ANI and NoL) when inhaled N2O is high (50%) testifying for the analgesic effect of this gas N2O.

Group Type OTHER

N2O exposure

Intervention Type DRUG

The aim of this study is to evaluate the nociceptive response to a standardized forearm electrical stimulus applied to patients under GA, during surgery, at different End-Tidal concentrations of N2O (ET-N2O: 0%-50%-25%-0%), and to see if ANI and NoL indices show less pain when inhaled N2O is higher.

Interventions

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N2O exposure

The aim of this study is to evaluate the nociceptive response to a standardized forearm electrical stimulus applied to patients under GA, during surgery, at different End-Tidal concentrations of N2O (ET-N2O: 0%-50%-25%-0%), and to see if ANI and NoL indices show less pain when inhaled N2O is higher.

Intervention Type DRUG

Other Intervention Names

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N2O

Eligibility Criteria

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Inclusion Criteria

* ASA status I, II or III
* Patients aged 18 to 70 years
* Laparotomy for gynecological or bowel 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

Exclusion Criteria

* When 100% O2 ventilation is required during anesthesia (except for the induction phase during which all the patients receive O2 100%).
* Patients having received intraocular injection of gas (such as SF6, C3F8, C2F6) within 3 months prior to the present surgery.
* Any condition where internal entrapped air could expand and become dangerous, such as:

* head injury within 6 months prior to surgery
* maxillofacial injuries within 6 months prior to surgery
* pneumothorax within 6 months prior to surgery
* gas embolism within 6 months prior to surgery
* decompression sickness within 6 months prior to surgery
* bubbles of emphysema known for this patient
* middle ear, inner ear and sinus surgery
* major abdominal distension/occlusion and emergent surgery for intestinal obstruction
* if air has been injected into the epidural space to determine the placement of the needle for epidural anesthesia (only saline is used in our center for the loss of resistance technique to place the catheter into the epidural space)

Any contra-indication or patient's refusal for epidural placement

* Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
* Unexpected surgical complications requiring strong haemodynamic support (transfusions, volume challenges, vasopressors, inotropic drugs).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Philippe Richebé

Full Professor of Anesthesiology and Pain medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Philippe Richebe, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

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Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Philippe Richebe, MD PhD

Role: CONTACT

Phone: +1-514-743-6558

Email: [email protected]

Nadia Godin, RN

Role: CONTACT

Phone: 514-252-3400

Email: [email protected]

Facility Contacts

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Philippe Richebe, Md PhD

Role: primary

Nadia Goding, RN

Role: backup

References

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Coulombe MA, Decary E, Maximos S, Brulotte V, Drolet P, Tanoubi I, Issa R, Zaphiratos V, Verdonck O, Fortier LP, Godin N, Idrissi M, Raft J, Richebe P. Assessing the antinociceptive effect of nitrous oxide to tetanic stimulation in anaesthetised patients with new intra-operative nociception monitors: An observational study. Eur J Anaesthesiol. 2021 May 1;38(5):512-523. doi: 10.1097/EJA.0000000000001431.

Reference Type DERIVED
PMID: 33399383 (View on PubMed)

Other Identifiers

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15064

Identifier Type: -

Identifier Source: org_study_id