Detection of Responsiveness and Awareness in Old Aged Patients During Laryngoscopy and Intubation Using Isolated Forearm Technique
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- IFT response was recorded at laryngoscopy and intubation
研究概览
简要总结
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.
详细描述
Objective
To compare inhalational induction versus intravenous induction regarding awareness during laryngoscopy and intubation in elderly patients undergoing day case elective surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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
干预措施: Sevoflurane (Drug)
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.
干预措施: TIVA (Drug)
结局指标
主要结局
IFT response was recorded at laryngoscopy and intubation
时间窗: 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.
次要结局
- Bispectral index monitor (BIS)(40 minutes)
- Modified Brice questionnaire(24 hours)
研究者
Raham Hasan Mostafa, MD
Assistant Professor
Ain Shams University