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

NCT05019560 | Completed Phase 4

• 1 other identifier: R 153 / 2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Awareness, Anesthesia; Recall Phenomenon; Inhalation; Gas

Keywords

TIVA; Isoflurane; old age

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Bispectral index monitor (BIS)

  40 minutes

• Modified Brice questionnaire

  24 hours

Study Arms (2)

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

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.

Drug: TIVA

Interventions

Sevoflurane DRUG

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

Also known as: Inhalational induction

Group A

TIVA DRUG

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

Also known as: Total Intravenous induction

Group B

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American society of anesthesiologists- Physical status (ASA-PS) I and II patients,
• aged 60 to 80 years,
• kg,
• both sexes,
• with intact hearing,
• undergoing elective day case surgery were included in the study.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Intraoperative Awareness; Respiratory Aspiration; Mucopolysaccharidosis IV

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Mucopolysaccharidoses; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Mucinoses; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 25, 2021
• Study Start: September 5, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 15, 2021
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)