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

NCT ID: NCT05019560

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-05
• Study Completion Date: 2021-11-15

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.

Conditions

Awareness, Anesthesia; Recall Phenomenon; Inhalation; Gas

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: 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

Group B

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.

Group Type: ACTIVE_COMPARATOR

TIVA

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Inhalational induction; Total Intravenous induction

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

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).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Raham Hasan Mostafa, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

R 153 / 2021

Identifier Type: -

Identifier Source: org_study_id