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临床试验/CTRI/2024/03/064544
CTRI/2024/03/064544已完成4 期

Effect Of Conventional Direct Laryngoscopy And Left Head Rotation Technique On Laryngeal View In Patients Undergoing Surgery Under The General Anaesthesia– A Prospective, Randomized Cross Over Study

All India Institute of Medical Sciences Bathinda1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
144
试验地点
1
主要终点
To compare the Cormack Lehane grading in two techniques of Direct laryngoscopy with conventional sniffing position and with left head rotation technique

研究概览

简要总结

In this prospective randomised cross-over study, patients will be enrolled based on the aforementioned inclusion and exclusion criteria. All the selected subjects will be assessed preoperatively and will be explained about the study in their vernacular language. A detailed patient information sheet (PIS) will be given to the patients or their next of kin. Written informed consent will be taken from the patients prior to enrolment. Detailed history and physical examination of patients will be done preoperatively. On the day of the surgery, patients will be shifted to the operation theatre and standard ASA monitors including Non-invasive blood pressure (NIBP), electrocardiography (ECG) and pulse oximetry (SpO2) monitoring will be attached. Blood pressure will be monitored at an interval of 1 minute during induction of anaesthesia as well as the total laryngoscopy sequence. Bispectral Index (BIS) monitoring sensors will be placed on the forehead after cleaning the forehead with an alcohol-based solution. BIS will be maintained between 40 and 60. A wide-bore intravenous (IV) cannula will be inserted.

Following preoxygenation for 3 minutes, induction of anaesthesia will be done with intravenous midazolam(0.02mg/kg), Lignocaine hydrochloride 2% (1.5 mg/kg), propofol(1-2mg/kg), Fentanyl (2mcg/kg) and vecuronium (0.1mg/kg). The sequence of laryngoscopy will be determined using computer generated randomisation sequence as AB or BA (A – Laryngoscopy with Sniffing position technique and B-Laryngoscopy with LeHeR technique)  in order to avoid bias in favour of either laryngoscopy techniques.

In the Sniffing position technique, patients will be placed in the supine position and a pillow will be placed under the patient’s occiput to facilitate cervical flexion and the head will be extended to attain extension of the atlanto-occipital joint. In the LeHeR technique, patients will be placed in supine position with simple neck extension and head rotated to the left up to 45 degrees with the aid of a Goniometer or protractor. Following pre-oxygenation and induction, direct laryngoscopy with the first technique as per the assigned sequence will be done and an assessment of CL grading will be done. After assessment of CL grading, the laryngoscope will be removed and mask ventilation will be done for 3 minutes. Laryngoscopy with the second technique as per the assigned sequence will be done and CL grading will be assessed. The final intubation will be done after the completion of the second laryngoscopy technique. Intubation Difficulty Scale (IDS) Score will be assessed for the technique used.

Titrated doses of propofol at a rate of 100 to 200 mcg/kg/min will be used for maintenance (BIS between 40-60) until the laryngoscopy sequences and intubation are completed.  A bolus of propofol (0.5 mg/kg) will be administered if SBP is increased by more than 20% from the previous reading during the laryngoscopy sequence. After intubation, the further course of anaesthesia will be decided as per the discretion of the anaesthesiology in charge of that case.

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • age more than 18 years and less than 70 years 2) Body Mass Index between 18.5 and 35 kg/m2 3) American Society of Anaesthesiologists physical status I,II and III 4) Mallampati grade I,II and III.

排除标准

  • pregnant patients 2) Thyromental distance less than 6 cm 3) Mouth opening less than 3 finger breadths 4) Limited head rotation 5) Mid facial anomalies 6) Neck anomalies 7) Facial fractures obstructing the airway 8) known gastroesophageal reflux 9) patients posted for emergency surgery 10) patients with a known history of coronary artery disease 11) patients who are not willing to participate.

结局指标

主要结局

To compare the Cormack Lehane grading in two techniques of Direct laryngoscopy with conventional sniffing position and with left head rotation technique

时间窗: At the end of Direct laryngoscopy

次要结局

  • To compare the Intubation Difficulty Scale with two techniques of Direct laryngoscopy with conventional sniffing position and left head rotation technique(At the end of intubation)

研究者

发起方
All India Institute of Medical Sciences Bathinda
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dinesh kumar AR

AIIMS Bathinda

研究点 (1)

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