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

Awareness, Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05019560
• Other study ID #: R 153 / 2021
• Status: Completed
• Phase: Phase 4
• Start date: September 5, 2021
• Est. completion date: November 15, 2021

Study information

• Verified date: January 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 15, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Awareness, Anesthesia
• Inhalation; Gas
• Intraoperative Awareness
• Recall Phenomenon

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes
Secondary	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	40 minutes
Secondary	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)	24 hours