Influence of Depth of Anesthesia on Pupillary Reactivity to a Standardized Stimulus

Hôpital Armand Trousseau

Status: Completed

Conditions: Pain

Treatments: Drug: Remifentanil; Device: TCI; Drug: propofol; Device: Algiscan; Procedure: Tetanic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02595476

Anesthésie Trousseau 002

Details and patient eligibility

About

A standardized tetanic stimulation is applied to patients under propofol-remifentanil TCI, in a cross-over fashion, at two different levels of anesthesia monitored by the BIS: BIS 25 and BIS 55. Remifentanil target remains constant during the whole study period (1 ng/ml). Pupillary reflex dilation is recorded after each stimulation.

Enrollment: 12 patients

Sex: All

Ages: 10 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA 1-2
• scheduled for an idiopathic scoliosis surgical correction

Exclusion criteria

• Ophtalmologic pathology
• Neurologic or muscular pathology
• Metabolic pathology
• Chronic pain

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

BIS 55

Experimental group

Description:

1. Induction: TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 55 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)

Treatment:

Device: TCI

Drug: Remifentanil

Device: Algiscan

Procedure: Tetanic stimulation

Drug: propofol

BIS 25

Active Comparator group

Description:

1. Induction: TCI propofol (6 µg/ml) - remifentanil (4 ng/ml) Atracurium IV (0.5 mg/kg) 2. Orotracheal Intubation 3. Remifentanil target decreased to 1 ng/ml 4. Propofol target adjustment to reach BIS 25 5. 10 minutes steady state 6. Tetanic stimulation (ulnar nerve): 100 Hz, 60 milliamps, 5 seconds 7. Pupillary dilation recording (videopupillometer Algiscan)

Treatment:

Device: TCI

Drug: Remifentanil

Device: Algiscan

Procedure: Tetanic stimulation

Drug: propofol