Infrared Pupillometry During General Anesthesia to Predict Pain

NCT02058511 | Terminated Results

• 1 other identifier: Pupillometry and Analgesia
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Postoperative Pain; Objective Assessment of Sedation

Outcome Measures

Primary Outcomes (1)

• 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

  at arrival in recovery room

Secondary Outcomes (1)

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

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

Other Outcomes (1)

• Hippus

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

Study Arms (1)

Intervention Group

EXPERIMENTAL

all enrolled patients undergo the same protocol/ treatment: Anesthesia Premedication, Induction and Maintenance Pupillometry after administration of anesthetic drugs

Drug: Anesthesia Premedication, Induction and Maintenance; Procedure: Pupillometry after administration of anesthetic drugs

Interventions

Anesthesia Premedication, Induction and Maintenance DRUG

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.

Intervention Group

Pupillometry after administration of anesthetic drugs PROCEDURE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Orthopedic Institute

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Neoadjuvant Therapy; Maintenance

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Health Care Facilities Workforce and Services

Limitations and Caveats

In patients under general anesthesia the PLR could not be seen with the stimulus chosen for the experiment. PLR recorded at the end of surgery were attributable to a lack of anesthesia. The trial was terminated after 24 subjects participated.

Results Point of Contact

• Title: Matthias Behrends
• Organization: UCSF

matthias.behrends@ucsf.edu

415 476 3761

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 10, 2014
• Study Start: November 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-02

Locations

US (1)