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Completed

NCT Number: NCT05019560

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.

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Key information

Conditions

Awareness, Anesthesia Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Inhalation; Gas Intraoperative Awareness Intraoperative Complications Lysosomal Storage Diseases Metabolic Diseases Metabolism, Inborn Errors Mucinoses Mucopolysaccharidoses Mucopolysaccharidosis IV Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recall Phenomenon Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Skin and Connective Tissue Diseases

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Sevoflurane

Drug

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

TIVA

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2021
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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