Skip to content

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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05019560
Enrollment
50
Registered
2021-08-25
Start date
2021-09-05
Completion date
2021-11-15
Last updated
2022-01-13

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

Conditions

Awareness, Anesthesia, Recall Phenomenon, Inhalation; Gas

Keywords

TIVA, Isoflurane, old age

Brief summary

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.

Detailed description

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

Interventions

DRUGSevoflurane

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

DRUGTIVA

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Randomization was performed using a computer-generated random number table in opaque sealed envelopes with 1:1 allocation ratio by an anesthesiologist not directly involved in the trial or patient care.

Intervention model description

Interventions: Patients were randomized into either Group A (who received inhalational induction) and Group B (who received total intravenous induction followed by maintenance infusion). Main outcome measure: IFT response was recorded at laryngoscopy and intubation to identify awareness at this stressful timepoint.

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
IFT response was recorded at laryngoscopy and intubation10 minutesScore 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

MeasureTime frameDescription
Bispectral index monitor (BIS)40 minutesValue 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
Modified Brice questionnaire24 hours2 hours and 24 hours after the end of anesthesia, patients were interviewed regarding the experience of dreaming or recall (of the induction period)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026