Recruiting

N2O with ANI & NoL

Sponsor:

Maisonneuve-Rosemont Hospital

Code:

NCT02701478

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

N2O exposure

Study Details

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

Study ID

NCT02701478

Start date

Jan, 2016

Status verified date

Nov, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: 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.

Interventions

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.

Primary outcome measure

  • ANI variation after stimulation in patients under GA at End-Tidal N2O 0% and 50%. [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Philippe Richebe, MD PhD

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

Nadia Godin, RN

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

Locations

Hopital Maisonneuve Rosemont

Recruiting

Montreal, Quebec, Canada, H1T2M4

Contacts

Philippe Richebe, Md PhD

+195140743-6558philipperichebe@live.com

Nadia Goding, RN

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

More Information

Sponsor

Maisonneuve-Rosemont Hospital

Last update posted

Nov 18, 2016

Last verified

Nov, 2016

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 2016-11-18.