Pupillary Diameter Under Different Concentrations of Propofol

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Drug: Propofol; Device: Pupillary diameter measurement

• Registration Number: NCT02998424
• Lead Sponsor: Hôpital Armand Trousseau

Brief Summary

Resting pupillary diameter was measured at a randomized Effect-site target concentration of propofol used as a sole anesthetic.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Study First Submitted: 2016-12-13
• Study First Submitted QC: 2016-12-16
• Study First Posted: 2016-12-20
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-25
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patient who has reached puberty
• ASA I or II who is scheduled for elective surgery under general anesthesia

Exclusion Criteria

• neurologic, metabolic, ocular disease
• chronic pain
• under medication that interferes with autonomic nervous system
• obesity
• patient requiering a rapid sequence induction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol 2 µg/ml	Propofol	Patients received a propofol infusion at an effect-site concentration of 2 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes.
Propofol 1 µg/ml	Pupillary diameter measurement	Patients received a propofol infusion at an effect-site concentration of 1 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes.
Propofol 1 µg/ml	Propofol	Patients received a propofol infusion at an effect-site concentration of 1 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes.
Propofol 2 µg/ml	Pupillary diameter measurement	Patients received a propofol infusion at an effect-site concentration of 2 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes.
Propofol 3 µg/ml	Propofol	Patients received a propofol infusion at an effect-site concentration of 3 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes.
Propofol 3 µg/ml	Pupillary diameter measurement	Patients received a propofol infusion at an effect-site concentration of 3 µg/ml at the beginning of induction of general anesthesia for elective surgery. Pupillary diameter measurement after 10 minutes.

Primary Outcome Measures

Name	Time	Method
Pupillary diameter	Instantaneous measure, 10 minutes after the beginning of the study period

Secondary Outcome Measures

Name	Time	Method
Bispectral Index (BIS)	continuous measure, recorded10 minutes after the beginning of the study period
Observer's Assessment of Alertness/Sedation Scale (OAAS)	10 minutes after the beginning of the study	Clinical score
Heart rate	continuous measure, recorded10 minutes after the beginning of the study period

Trial Locations

Locations (1)

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