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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Remifentanil; Drug: propofol; Device: TCI; Procedure: Tetanic stimulation; Device: Algiscan

• Registration Number: NCT02595476
• Lead Sponsor: Hôpital Armand Trousseau

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Primary Completion: 2016-01
• Study Completion: 2016-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIS 55	propofol	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)
BIS 55	TCI	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)
BIS 55	Tetanic stimulation	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)
BIS 55	Algiscan	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)
BIS 25	Remifentanil	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)
BIS 25	propofol	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)
BIS 25	TCI	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)
BIS 25	Tetanic stimulation	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)
BIS 25	Algiscan	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)
BIS 55	Remifentanil	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)

Primary Outcome Measures

Name	Time	Method
Post-stimulation Pupillary reflex dilation	30 seconds	percentage of dilation compared to pre-stimulation pupillary diameter

Trial Locations

Locations (1)

Departement d'anesthesie Hopital Armand Trousseau; 🇫🇷 Paris, France