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

NCT02701478 | Unknown Phase 4

• 1 other identifier: 15064
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• ANI variation after stimulation in patients under GA at End-Tidal N2O 0% and 50%.

  The same patient is anesthetized without N2O in the gas mixture first. The first standard stimulus is applied on the forearm of the patient when the N2O concentration in the anesthesia mixture is at 0%. ANI response to the stimulus is recorded. Then N2O is slowly increased to reached et-N2O 50% in the anesthesia mixture. Then, at ET-N2O 50%, the same standard stimulus is applied and ANI variations registered.

  First stimulus is applied when the patient breaths 0% N2O in his anesthesia mixture. Second stimulus is applied at 50% End-Tidal N2O in the anesthesia mixture during the surgery.

Secondary Outcomes (2)

• NoL index variation after electrical stimulation in patients under GA atEnd-Tidal N2O 0% and 50%.

  First stimulus is applied when the patient breaths 0% N2O in his anesthesia mixture. Second stimulus is applied at 50% End-Tidal N2O in the anesthesia mixture during the surgery.

• ANI and NoL indices variations after the same standard stimulus when ET-N2O is slowly decreased from 50% to 25%, , then to 0%.

  Within the same anesthesia and surgery

Study Arms (1)

N2O exposure

OTHER

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.

Drug: N2O exposure

Interventions

N2O exposure 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.

Also known as: N2O

N2O exposure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

Study Sites (1)

Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T2M4, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 33399383 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Richebe, MD PhD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Richebe, MD PhD

CONTACT

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

Nadia Godin, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Anesthesiology and Pain medicine

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 8, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 18, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)