Back to resultsAwareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique
Primary Purpose
Awareness, Anesthesia, Recall Phenomenon, Inhalation; Gas
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Sevoflurane
TIVA
Sponsored by
About this trial
This is an interventional diagnostic trial for Awareness, Anesthesia focused on measuring TIVA, Isoflurane, old age
Eligibility Criteria
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).
Sites / Locations
- Ain Shams University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
In group A: The researcher, who supervised the anesthesia, explained the concept of the study to all patients before induction, and then a tourniquet was placed around the dominant arm of the patients after placing a cotton bandage; to be inflated to 200mmHg or 40 mmHg above the systolic blood pressure of the patient; immediately before administration of the muscle relaxant later on. Patients received inhalation induction using sevoflurane 8% and fentanyl 2 µg/kg was administered intravenously. After loss of consciousness, and BIS value of 50 or less, the tourniquet cuff was inflated then atracurium 0.5 mg/kg was given intravenously and sevoflurane reduced to 2%, then laryngoscopy and intubation were done when action of neuromuscular blocker (NMB) was confirmed by the disappearance of T3,T4. During this time, mask assisted ventilation with 100% oxygen was used to achieve normocapnia
In group B: The researcher, who supervised the anesthesia, explained the concept of the study to all patients before induction, and then a tourniquet was placed around the dominant arm of the patients after placing a cotton bandage; to be inflated to 200mmHg or 40 mmHg above the systolic blood pressure of the patient; immediately before administration of the muscle relaxant later on. In group B: propofol 1.5 mg/kg and fentanyl 2 µg/kg were administered intravenously. After loss of consciousness, and BIS value of 50 or less, the tourniquet cuff was inflated and then atracurium 0.5 mg/kg was given intravenously. Propofol infusion 6 mg/kg/hr was started, until action of neuromuscular blocker (NMB) was confirmed by disappearance of T3,T4, then laryngoscopy and intubation were done. The used dosing regimen is according to previous guidelines [8] [9].No inhalational agent was used. Mask assisted ventilation was used to achieve normocapnia.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05019560
Brief Title
Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique
Official Title
Detection of Responsiveness and Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2021 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
November 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Awareness, Anesthesia, Recall Phenomenon, Inhalation; Gas
Keywords
TIVA, Isoflurane, old age
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
In group A:
The researcher, who supervised the anesthesia, explained the concept of the study to all patients before induction, and then a tourniquet was placed around the dominant arm of the patients after placing a cotton bandage; to be inflated to 200mmHg or 40 mmHg above the systolic blood pressure of the patient; immediately before administration of the muscle relaxant later on.
Patients received inhalation induction using sevoflurane 8% and fentanyl 2 µg/kg was administered intravenously. After loss of consciousness, and BIS value of 50 or less, the tourniquet cuff was inflated then atracurium 0.5 mg/kg was given intravenously and sevoflurane reduced to 2%, then laryngoscopy and intubation were done when action of neuromuscular blocker (NMB) was confirmed by the disappearance of T3,T4. During this time, mask assisted ventilation with 100% oxygen was used to achieve normocapnia
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
In group B:
The researcher, who supervised the anesthesia, explained the concept of the study to all patients before induction, and then a tourniquet was placed around the dominant arm of the patients after placing a cotton bandage; to be inflated to 200mmHg or 40 mmHg above the systolic blood pressure of the patient; immediately before administration of the muscle relaxant later on.
In group B: propofol 1.5 mg/kg and fentanyl 2 µg/kg were administered intravenously. After loss of consciousness, and BIS value of 50 or less, the tourniquet cuff was inflated and then atracurium 0.5 mg/kg was given intravenously. Propofol infusion 6 mg/kg/hr was started, until action of neuromuscular blocker (NMB) was confirmed by disappearance of T3,T4, then laryngoscopy and intubation were done. The used dosing regimen is according to previous guidelines [8] [9].No inhalational agent was used. Mask assisted ventilation was used to achieve normocapnia.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Inhalational induction
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
TIVA
Other Intervention Name(s)
Total Intravenous induction
Intervention Description
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
Primary Outcome Measure Information:
Title
IFT response was recorded at laryngoscopy and intubation
Description
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 Outcome Measure Information:
Title
Bispectral index monitor (BIS)
Description
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
Title
Modified Brice questionnaire
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Ain Shams University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request
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Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique
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