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

Phase 4CompletedNCT05019560

Ain Shams University50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Enrollment

Conditions

Awareness, Anesthesia Recall Phenomenon Inhalation; Gas

Interventions

SevofluraneDRUG

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

TIVADRUG

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

IFT response was recorded at laryngoscopy and intubation

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.

Time frame: 10 minutes

Secondary Outcomes

Bispectral index monitor (BIS)

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

Time frame: 40 minutes

Modified Brice questionnaire

2 hours and 24 hours after the end of anesthesia, patients were interviewed regarding the experience of dreaming or recall (of the induction period)

Time frame: 24 hours