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Infrared Pupillometry During General Anesthesia to Predict Pain

Intraoperative Use of Infrared Pupillometry During General Anesthesia to Predict Pain and Quality of Regional Anesthesia After Surgery

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02058511
Enrollment
24
Registered
2014-02-10
Start date
2012-11-30
Completion date
2016-11-30
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Objective Assessment of Sedation, Postoperative Pain

Brief summary

The study comprises of a series of pupillary measurements using infrared pupillometry in patients undergoing arthroscopic knee surgery of any type. Infrared pupillometry will be used to assess whether a painful stimulus results in pupillary reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is. This may help to predict the amount of discomfort a patient will be experiencing after emergence from general anesthesia. In addition to measuring the pupillary reflex dilation, we will also measure oscillations of pupil size before and after indiction of anesthesia, as well as during recovery. These spontaneously occuring oscillations in pupil size, also called hippus, appear to be sensitive to anesthetics and opioids. However, the effect of these drugs on hippus has not been systematically addressed. The aim of the study is 1. to identify whether regional anesthesia techniques such as femoral and sciatic nerve blocks will block the PRD. This would allow assessment of block success in the anesthetized patient. 2. to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized patient during and at the end of surgery with early postoperative pain scores and subsequent analgesia requirements. Such correlation would allow to predict the amount of postoperative pain before the patients emerge from general anesthesia.

Detailed description

The planned study is a prospective cohort study. Patients undergoing arthroscopic knee surgery of any type (debridements, repair of anterior (ACL) or posterior cruciform ligaments (PCL), meniscectomies, medial (MCL) or lateral collateral ligament (LCL) repair, as well as microfracture surgery will be enrolled. During anesthesia, infrared pupillometry will be used to assess whether a painful stimulus results in pupillary reflex dilation (PRD). The extend of the PRD may be an indicator how painful a stimulus is. The PRD is measurable under general anesthesia in spite of the fact that the patient does not feel or experience the painful stimulus. The aim of the study is 1. to identify whether regional anesthesia techniques such as femoral and sciatic nerve blocks (performed before the start of anesthesia) will block the PRD evoked by a painful stimulus such electrical stimulation before procedure start. This would allow assessment of block success in the anesthetized patient. 2. to correlate the extent of the pupillary reflex dilation and hippus in the anesthetized patient during and at the end of surgery with early postoperative pain scores and subsequent analgesia requirements. Such correlation would allow to predict the amount of postoperative pain before the patients emerge from general anesthesia. Knee arthroscopies are routinely performed under general anesthesia with or without regional anesthesia, depending on the anticipated extent of surgery and the preferences of the anesthesiologist and surgeon. The assessment of the PRD and/or hipppus before emergence would identify those patients who would benefit from an additional nerve block before emergence to achieve better pain control immediately postoperatively and to reduce the demand for postoperative analgesics. The planned investigation tries to achieve two novel findings. First, the measurement of the PRD at the start of surgery will demonstrate whether a nerve block successfully blocks the initial surgical stimulus. There is currently no method available that can assess block success in the anesthetized patient. Secondly, the measurement at the end of the surgery tries to predict the amount of pain following emergence from surgery. Pain may be experienced by patients without nerve blocks as well as with nerve blocks, as the latter may have failed or incomplete blocks, or may had a more extensive procedure that cannot be completely covered by the block administered preoperatively. Identifying these patients may allow treatment to minimize discomfort following emergence. Pupillary reflex dilation describes the dilation of the pupil following a painful stimulus. The dilation last several seconds. Pupillometry using an infrared pupillometer allows the quantification of the reflex dilation. The PRD can be given a numerical value that reflects the extent of the dilation. A recently published study demonstrated the correlation of the extend of the PRD with pain scores and opioid requirements postoperatively. However, this study was done in awake patients following surgery. The aim of this study is to predict analgesia requirements in patients still under general anesthesia, before they experience postoperative pain. We expect that infrared pupillometry during general anesthesia can predict pain following surgery. Once this has been established, this knowledge and its application would allow the anesthesiologist to initiate pain-relieving interventions such as additional nerve blocks or administration of analgesics before emergence of the patients from general anesthesia. In addition to measuring the pupillary reflex dilation, we will also measure oscillations of pupil size before and after induction of anesthesia, as well as during recovery. These spontaneously occurring oscillations in pupil size, also called hippus, appear to be sensitive to anesthetics and opioids. However, the effect of these drugs on hippus has not been systematically addressed.

Interventions

DRUGAnesthesia 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.

PROCEDUREPupillometry 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 iv, Fentanyl 1mcg/kg body weight, Propofol for anesthesia induction 2-2.5 mg/kg body weight, Sevoflurane as needed for maintenance of general anesthesia.

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Patients older than 18 years undergoing arthroscopic knee surgery of any type

Exclusion criteria

* Blindness * Anisocoria * History of opioid abuse * Chronic pain patients * Gastric Reflux Disease (due to the use of laryngeal masks in the study) * Non english speaking patients * Cognitive impairment

Design outcomes

Primary

MeasureTime frameDescription
Pain in Recovery Roomat arrival in recovery roomPain 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

Secondary

MeasureTime frameDescription
Number of Patients we Were Able to Elicit a PLR Under Stable Experimental Conditionsmeasurements were taken at two time points during surgery. Each measurement took 30 secondsPupillary 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.

Other

MeasureTime frameDescription
HippusBefore 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
24
Total24

Baseline characteristics

CharacteristicIntervention Group
Age, Continuous43 years
STANDARD_DEVIATION 13
Region of Enrollment
United States
24 participants
Sex: Female, Male
Female
15 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 24
serious
Total, serious adverse events
0 / 24

Outcome results

Primary

Pain 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

Time frame: at arrival in recovery room

ArmMeasureValue (MEAN)Dispersion
Intervention GroupPain in Recovery Room5 score on a scaleStandard Deviation 2
Secondary

Number of Patients we Were Able to Elicit a PLR Under Stable Experimental Conditions

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.

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Intervention GroupNumber of Patients we Were Able to Elicit a PLR Under Stable Experimental Conditions0 Participants
Other Pre-specified

Hippus

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.

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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026