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

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

Interventional

Enrollment (Actual)

50

Phase

  • 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

      • 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

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
Intervention / Treatment
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
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.
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

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

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.

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)

September 5, 2021

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

November 15, 2021

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

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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