Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique

January 12, 2022 updated by: Raham Hasan Mostafa, MD, Ain Shams University

Detection of Responsiveness and Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique

Awareness during general anesthesia - that has an incidence between 0.1% and 0.9% of cases and may be more in elderly - remains a concern for anesthesiologists. Awareness experiences range from isolated auditory perceptions to reports of a patient being fully awake, immobilized, and in pain. The isolated forearm technique allows assessment of consciousness of the external world (connected consciousness) through a verbal command to move the hand (of a tourniquet-isolated arm) during intended general anesthesia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective: To compare inhalational induction versus intravenous induction regarding awareness during laryngoscopy and intubation in elderly patients undergoing day case elective surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 50 American society of anesthesiologists- Physical status (ASA-PS) I and II patients,
  • aged 60 to 80 years,
  • 70-80 kg,
  • both sexes,
  • with intact hearing,
  • undergoing elective day case surgery were included in the study.

Exclusion Criteria:

  1. Uncooperative patients,
  2. Language barrier problems,
  3. Psychological disorders,
  4. Suspected difficult intubation,
  5. History of awareness under anesthesia,
  6. History of substance abuse,
  7. The inability to have tourniquet on arm for the IFT (e.g., lymphedema or operative site)
  8. Neuromuscular disorders.
  9. Advanced renal, hepatic, cardiac, respiratory or neurological dysfunction
  10. If rapid sequence induction was indicated (not suitable for inhalation induction).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group A

In group A:

  • The researcher, who supervised the anesthesia, explained the concept of the study to all patients before induction, and then a tourniquet was placed around the dominant arm of the patients after placing a cotton bandage; to be inflated to 200mmHg or 40 mmHg above the systolic blood pressure of the patient; immediately before administration of the muscle relaxant later on.
  • Patients received inhalation induction using sevoflurane 8% and fentanyl 2 µg/kg was administered intravenously. After loss of consciousness, and BIS value of 50 or less, the tourniquet cuff was inflated then atracurium 0.5 mg/kg was given intravenously and sevoflurane reduced to 2%, then laryngoscopy and intubation were done when action of neuromuscular blocker (NMB) was confirmed by the disappearance of T3,T4. During this time, mask assisted ventilation with 100% oxygen was used to achieve normocapnia
Drug: Sevoflurane
IFT response, hemodynamics and BIS value were recorded during intubation period. Then the data acquisition was stopped and the isolated forearm cuff deflated. IFT values were noted by two independent observers
Other Names:
  • Inhalational induction
Active Comparator: Group B

In group B:

  • The researcher, who supervised the anesthesia, explained the concept of the study to all patients before induction, and then a tourniquet was placed around the dominant arm of the patients after placing a cotton bandage; to be inflated to 200mmHg or 40 mmHg above the systolic blood pressure of the patient; immediately before administration of the muscle relaxant later on.
  • In group B: propofol 1.5 mg/kg and fentanyl 2 µg/kg were administered intravenously. After loss of consciousness, and BIS value of 50 or less, the tourniquet cuff was inflated and then atracurium 0.5 mg/kg was given intravenously. Propofol infusion 6 mg/kg/hr was started, until action of neuromuscular blocker (NMB) was confirmed by disappearance of T3,T4, then laryngoscopy and intubation were done. The used dosing regimen is according to previous guidelines [8] [9].No inhalational agent was used. Mask assisted ventilation was used to achieve normocapnia.
Drug: TIVA
IFT response, hemodynamics and BIS value were recorded during intubation period. Then the data acquisition was stopped and the isolated forearm cuff deflated. IFT values were noted by two independent observers
Other Names:
  • Total Intravenous induction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IFT response was recorded at laryngoscopy and intubation
Time Frame: 10 minutes
Score is from zero to 5 Increasing score means increasing risk of awareness especially if >3 The primary outcome was IFT response was recorded at laryngoscopy and intubation to identify awareness at this stressful timepoint.
10 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bispectral index monitor (BIS)
Time Frame: 40 minutes

Value from 100 to zero. 100 means fully awake We aim to be with in 40-60 intraoperatively to decrease risk of awareness

BIS values were recorded at the following timings:

  • Baseline
  • After induction and muscle relaxation,
  • During laryngoscopy,
  • After successful intubation
  • After 20 minutes from skin incision
  • After 40 minutes from skin incision
40 minutes
Modified Brice questionnaire
Time Frame: 24 hours
2 hours and 24 hours after the end of anesthesia, patients were interviewed regarding the experience of dreaming or recall (of the induction period)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R 153 / 2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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