Trial Outcomes & Findings for Infrared Pupillometry During General Anesthesia to Predict Pain (NCT NCT02058511)

Results Overview

Pain as assessed by visual analogue score at arrival of the patient in the recovery room Scale goes from 0-10, with 10 indicating the worst pain possible

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

at arrival in recovery room

Results posted on

2019-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Group all enrolled patients undergo the same protocol/ treatment: Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs Anesthesia Premedication, Induction and Maintenance: The enrolled patients receive standard of care general anesthesia for knee arthroscopy. No additional pharmacological interventions are performed in study participants. The administered drugs, as outlined in the arms section, are midazolam, fentanyl, propofol, and sevoflurane. Study patients receive analgesic drugs as needed in the recovery room if they experience pain. Pupillometry after administration of anesthetic drugs: All study patients receive the standard of anesthetic care. Every time a anesthetic drug has been administered, changes in pupillary oscillations will be recorded. Assessment of pupil size and movements by shining infrared light into the eye and measuring the reflection over a 20 s period The administered drugs are: Midazolam 1-2 mg
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Infrared Pupillometry During General Anesthesia to Predict Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=24 Participants all enrolled patients undergo the same protocol/ treatment: Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs Anesthesia Premedication, Induction and Maintenance: The enrolled patients receive standard of care general anesthesia for knee arthroscopy. No additional pharmacological interventions are performed in study participants. The administered drugs, as outlined in the arms section, are midazolam, fentanyl, propofol, and sevoflurane. Study patients receive analgesic drugs as needed in the recovery room if they experience pain. Pupillometry after administration of anesthetic drugs: All study patients receive the standard of anesthetic care. Every time a anesthetic drug has been administered, changes in pupillary oscillations will be recorded. Assessment of pupil size and movements by shining infrared light into the eye and measuring the reflection over a 20 s period The administered drugs are: Midazolam 1-2 mg
Age, Continuous	43 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants

PRIMARY outcome

Timeframe: at arrival in recovery room

Pain as assessed by visual analogue score at arrival of the patient in the recovery room Scale goes from 0-10, with 10 indicating the worst pain possible

Outcome measures

Outcome measures
Measure	Intervention Group n=24 Participants all enrolled patients undergo the same protocol/ treatment: Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs Anesthesia Premedication, Induction and Maintenance: The enrolled patients receive standard of care general anesthesia for knee arthroscopy. No additional pharmacological interventions are performed in study participants. The administered drugs, as outlined in the arms section, are midazolam, fentanyl, propofol, and sevoflurane. Study patients receive analgesic drugs as needed in the recovery room if they experience pain. Pupillometry after administration of anesthetic drugs: All study patients receive the standard of anesthetic care. Every time a anesthetic drug has been administered, changes in pupillary oscillations will be recorded. Assessment of pupil size and movements by shining infrared light into the eye and measuring the reflection over a 20 s period The administered drugs are: Midazolam 1-2 mg
Pain in Recovery Room	5 score on a scale Standard Deviation 2

SECONDARY outcome

Timeframe: measurements were taken at two time points during surgery. Each measurement took 30 seconds

Pupillary Reflex Dilation is measured intraoperatively at incision and at the end of the case as a possible indicator of success of regional anesthesia. Measurement of this requires stable experimental conditions, most notably sufficient depth of anesthesia.

Outcome measures

Outcome measures
Measure	Intervention Group n=24 Participants all enrolled patients undergo the same protocol/ treatment: Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs Anesthesia Premedication, Induction and Maintenance: The enrolled patients receive standard of care general anesthesia for knee arthroscopy. No additional pharmacological interventions are performed in study participants. The administered drugs, as outlined in the arms section, are midazolam, fentanyl, propofol, and sevoflurane. Study patients receive analgesic drugs as needed in the recovery room if they experience pain. Pupillometry after administration of anesthetic drugs: All study patients receive the standard of anesthetic care. Every time a anesthetic drug has been administered, changes in pupillary oscillations will be recorded. Assessment of pupil size and movements by shining infrared light into the eye and measuring the reflection over a 20 s period The administered drugs are: Midazolam 1-2 mg
Number of Patients we Were Able to Elicit a PLR Under Stable Experimental Conditions	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Before anesthesia start (baseline measurement) until discharge of the patient (on average 1-2 hours after arrival in the recovery room)

We assess the effects of various anesthetic drugs on pupillary unrest (hippus). More specifically, we record pupil diameters over 20 seconds and then perform a Fourier Analysis of the diameter changes. The endpoint variable is power of the oscillations over certain predefined frequency bins.

Outcome measures

Outcome data not reported

Adverse Events

Intervention Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthias Behrends

UCSF

Phone: 415 476 3761

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place