Awareness, AnesthesiaPhase 4NCT05019560
Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique
A Phase 4 study testing Sevoflurane and TIVA in people with Awareness, Anesthesia and Recall Phenomenon, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Awareness, Anesthesia, Recall Phenomenon, Inhalation; Gas
- What is being tested?
- Sevoflurane and TIVA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Sep 2021to 15 Nov 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Uncooperative patients,
- Language barrier problems,
- Psychological disorders,
- Suspected difficult intubation,
- History of awareness under anesthesia,
- History of substance abuse,
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Objective: To compare inhalational induction versus intravenous induction regarding awareness during laryngoscopy and intubation in elderly patients undergoing day case elective surgery.
- Conditions
- Awareness, Anesthesia, Recall Phenomenon, Inhalation; Gas
- Being tested
- Sevoflurane, TIVA
- Keywords
- TIVA, Isoflurane, old age
- Medical subject headings
- Intraoperative Awareness, Respiratory Aspiration, Mucopolysaccharidosis IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Inhalational induction
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
Also called Total Intravenous induction
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
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 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 Receives: Drug: Sevoflurane |
| Group B | Active comparator | 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. Receives: Drug: TIVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes
Secondary outcomes (2)
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
Measured: 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)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start5 Sep 2021
- Primary completion1 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awareness, AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raham Hasan Mostafa, MD, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019560
- Sponsor's protocol ID
- R 153 / 2021
- Status last verified
- Jan 2022
- First submitted
- 19 Aug 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Responsiveness and Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique
- ClinicalTrials.gov ID
- NCT05019560
- Acronym / sponsor ID
- R 153 / 2021
- Conditions
- Awareness, Anesthesia, Recall Phenomenon, Inhalation; Gas
- Keywords
- TIVA, Isoflurane, old age
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: SevofluraneIn 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 |
| Group B | Active comparator | Drug: TIVAIn 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (10 listed)
- Uncooperative patients,
- Language barrier problems,
- Psychological disorders,
- Suspected difficult intubation,
- History of awareness under anesthesia,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluraneAlso: Inhalational inductionIFT 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 | Drug | Group A |
| TIVAAlso: Total Intravenous inductionIFT 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 | Drug | Group B |
Primary outcome
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.
2 secondary outcomes
Bispectral index monitor (BIS)
Time frame: 40 minutes
Modified Brice questionnaire
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: No. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and TIVA in people with Awareness, Anesthesia and Recall Phenomenon, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IFT response was recorded at laryngoscopy and intubation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.