- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05019560
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
Status
Completed
Intervention / Treatment
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
-
-
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Cairo, Egypt
- Ain Shams University
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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:
- 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).
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:
|
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:
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Active Comparator: Group B
In group B:
|
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:
|
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.
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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:
|
40 minutes
|
Modified Brice questionnaire
Time Frame: 24 hours
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2 hours and 24 hours after the end of anesthesia, patients were interviewed regarding the experience of dreaming or recall (of the induction period)
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24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R 153 / 2021
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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