ConsCIOUS2 Study of the Isolated Forearm Technique Commands

ConsCIOUS2: A Prospective Study of the Isolated Forearm Technique Commands, Long-term Sequelae and Electroencephalograph Correlates Following Laryngoscopy and Intubation in Patients 18 - 40 Years of Age

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03503357

Enrollment

344

Registered

2018-04-19

Start date

2018-04-04

Completion date

2019-12-23

Last updated

2021-12-03

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

Conditions

Anesthesia Awareness

Keywords

Consciousness, Electroencephalography, Anesthesia

Brief summary

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

Detailed 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.

Interventions

OTHERIFT Testing1

Command List A

OTHERIFT Testing 2

Command List B

OTHERIFT Testing 3

Command List C

OTHERIFT Testing 4

Command List D

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Responsiveness	Intra-operative	Identify the incidence of IFT responsiveness following intubation assessed by hand squeezing response following a randomized command sequence to assess for non-specific responses.

Secondary

Measure	Time frame	Description
Patient Reported Confusion Following Emergence	15 minutes and 60 minutes after PACU admission	Test the association between intra-operative IFT responsiveness and patient reported confusion following emergence from anesthesia and objectively assessed confusion using the NuDesc
EEG	Intra-operative	Collect EEG data to identify monitoring patterns that discriminate responders and non-responders
Anesthesia Awareness with Recall	24 hours and 7 days post-op	Identify the incidence of implicit memory in post anesthesia care unit and anesthesia awareness with recall 24 hours and 7 days postoperatively using the structured Modified Brice questionnaire
Anesthesia Satisfaction	24 hours and 7 days post-op	Identify changes in patient satisfaction associated with IFT responsiveness via a patient satisfaction questionnaire administered 24 hours and 7 days postoperatively.
Predisposing Factors	Pre-operative	Chart review of demographic factors that predispose to IFT responsiveness.

Countries

Australia, Belgium, Germany, Israel, Netherlands, New Zealand, United States

Outcome results

None listed

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