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临床试验/CTRI/2025/03/082560
CTRI/2025/03/082560招募中不适用

COMPARISON OF AMBU AURAGAIN AND PROSEAL LMA IN ADULT PATIENTS UNDERGOING LAPROSCOPIC SURGERY

Dr N DURGA MAHADEV1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月31日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
SUPRA GLOTTIC AIRWAY DEVIDES offer ease of Insertion , with less post operative complications along with high Oropharyngeal pressure

研究概览

简要总结

Patients will be assessed and scheduled for routine major surgery

10min before surgery

Pre-medication will be given with

Inj.Midazolam 0.02mg/kg IV , Inj.Fentanyl 1.5 µg/kg I.V

Induction is done with Inj. Propofol - 2mg/kg IV  mg/kg, and Inj. Atracurium - 0.5 mg/kg to facilitate SupraGlottic Airway Device(SAD) insertion.

SAD insertion will be done using an appropriate sized SAD as per the manufacturers recommendations and by an experienced anesthesiologist.

During insertion, the following manipulations were allowed: jaw thrust, adjusting insertion depth or head extension, and flexion beyond the sniffing position. If required, any maneuver among the three was opted as per the choice of the anesthesiologist. A maximum of three attempts was allowed. If not successful after three attempts, insertion was considered a failure and an alternative technique was used for airway management and excluded from the study.

The appropriate placement was confirmed by proper chest expansion, auscultation, and square waveform on the capnograph. Insertion time was defined as the time from the picking up of the device to the appearance of the first waveform of the end-tidal carbon dioxide. It was calculated by adding the time taken for each attempt, but the time between the two attempts will not be added.

We will assess the ease of insertion according to the above-mentioned maneuvers during insertion as follows: easy,fair,difficult.

The Ambu AuraGain cuff is inflated and we will note down the cuff pressure(CP). The amount of air required to inflate the cuff, up to 60 cm H2O in PROSEAL LMA, 30cm H2O or 45cm H2O in Ambu AuraGain will be noted for both SADs.

OLP will be recorded with the adjustable pressure limiting valve fully closed and oxygen flow maintained at 3 L/min. The pressure at which an audible leak occurred or up to a maximum pressure of 40 cm H2O was noted as OLP.

Ventilatory parameters like inspiratory tidal volume (ITV), expiratory tidal volume (ETV), EtCO2, peak airway pressure (PAP) were noted at 1, 5, 15, 30, 60, 90, 120 min after connecting the patient on to the ventilator. Leak percent = ITV-ETV/ITV x 100 is calculated

The anatomic position of devices will be evaluated using a fibre-optic bronchoscope and graded on a scale of 1-4 as follows:

1:Vocal cords fully visible;

2: Vocal cords partially visible or arytenoids cartilages visible;

3: Epiglottis visible;

4: No laryngeal structures visible.

A well-lubricated gastric tube will be passed through the female port into the gastric access channel of Ambu AuraGain ( F 10 - 12 ) and a drain tube of PROSEAL LMA (F 12 - 14 ).

Ease of gastric tube placement will be graded as follows: 1. (easy: one attempt); 2. (difficult: >1 attempt); 3. (impossible).

Hemodynamic parameters, SpO2, ETCO2 were noted just before device insertion, 1, 5, 15, 30,60,90,120 min after device insertion and then monitored throughout the surgery

Ventilatory Parameters are set according to the weight of the body

Maintenance of anaesthesia will be done using O2, N20, Sevoflurane and inj. Atracurium bromide (0.1 mg/kg) IV.

After completion of surgery all patient will be reversed with Inj. Neostigmine (0.05 mg/kg) and Inj. Glycopyrolate (0.004 mg/kg) IV.

Time taken for removal of SAD will be noted and presence of blood stains is to be observed.

Post Operative Vitals at 1, 5, 15, 30,60,90,120 min will be recorded.

Complications like Sorethroat, Cough, Nausea, Vomiting, Hoarseness of Voice will be recorded

The main purpose of this trial is to observe which SAD (AMBU AURAGAIN AND PROSEAL LMA) provides better hemodynamic stability and less postoperative complications

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients with normal airway MPG 1,2 ASA grade I.
  • III All subjects scheduled for elective laparoscopic surgery.

排除标准

  • Emergency Surgeries Individuals with known or anticipated Difficult Intubation Patient with ASA ≥ IV Pregnancy with high-risk of aspiration.

结局指标

主要结局

SUPRA GLOTTIC AIRWAY DEVIDES offer ease of Insertion , with less post operative complications along with high Oropharyngeal pressure

时间窗: HEMODYNAMICS WILL BE OBSERVED INTRAOPERATIVE AND POSTOPERATIVELY | BASELINE,1MIN,5MIN,15MIN,20MIN,30MIN,60MIN,120MIN

次要结局

  • WHICH IS THE BETTER HEMODYNAMICALLY STABLE(AMBU AURAGAIN OR PROSEAL LMA)

研究者

发起方
Dr N DURGA MAHADEV
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

NUKALA DURGA MAHADEV

P.D.U. Government Medical College Rajkot

研究点 (1)

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