ConsCIOUS2 Study of the Isolated Forearm Technique Commands

University of Wisconsin (UW)

Status: Completed

Conditions: Anesthesia Awareness

Treatments: Other: IFT Testing 2; Other: IFT Testing 3; Other: IFT Testing1; Other: IFT Testing 4

Study type: Interventional

Funder types: Other

Identifiers

NCT03503357

2017-0728

A530900 (Other Identifier)

SMPH\ANESTHESIOLOGY\ANESTHESIO (Other Identifier)

Details and patient eligibility

About

ConsCIOUS-2 is a multi-site study exploring the cognitive state of the Isolated Forearm Test (IFT) responder while under anesthetic.

Full description

500 participants between the ages of 18-40 who will be undergoing surgery requiring general anesthetic will be recruited for this study. This study will use the Isolated Forearm Test (IFT) to identify patients at risk of anesthesia awareness. In the IFT, induction of anesthesia is followed by inflation of a cuff on the dominant arm before neuromuscular blockade (paralysis) is induced. The cuff prevents paralysis of the hand allowing the patient to communicate to an observer through predefined hand movements, typically following a command like: "Mrs. Jones, if you can hear me, squeeze my hand". Participants will thus be asked to follow a series of commands intraoperatively to assess awareness.

Routinely recorded clinical data will be collected to frame the observations about IFT responsiveness, and non-invasive EEG data will also be collected to provide information about the "brain state" of the patients. Patient reported confusion and objectively measured confusion using the Nurse Based Delirium Screening Tool (NuDesc) will be collected post operatively. Finally, participants will be contacted 24 hours and 7 days following their operation to complete an anesthesia satisfaction questionnaire.

Enrollment: 344 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18-40 years
2. English (or local language) competent
3. Informed consent obtained
4. Patients clinically requiring general anesthesia and intubation
5. Able to safely follow the IFT commands when awake and prior to their operation, per discretion of the PI.

Exclusion criteria

1. Age < 18 years old, >40 years old
2. Unable or unwilling to sign consent
3. Unable to undergo postoperative questions
4. Contraindication to IFT test such as unable to have tourniquet on arm for the IFT (e.g. lymphedema or operative site), rapid sequence inductions and requiring paralysis for laryngoscopy and intubation, per discretion of the PI.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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344 participants in 4 patient groups

IFT Testing 1

Experimental group

Description:

Participants will be fitted with and IFT cuff and randomized to command list A intra-operatively to assess awareness.

Treatment:

Other: IFT Testing1

IFT Testing 2

Experimental group

Description:

Participants will be fitted with and IFT cuff and randomized to command list B intra-operatively to assess awareness.

Treatment:

Other: IFT Testing 2

IFT Testing 3

Experimental group

Description:

Participants will be fitted with and IFT cuff and randomized to command list C intra-operatively to assess awareness.

Treatment:

Other: IFT Testing 3

IFT Testing 4

Experimental group

Description:

Participants will be fitted with and IFT cuff and randomized to command list D intra-operatively to assess awareness.

Treatment:

Other: IFT Testing 4