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临床试验/CTRI/2024/11/077045
CTRI/2024/11/077045尚未招募4 期

Comparative Study Of Continuous Infusion With Intermittent Bolus Of Propofol During ERCP Using Laryngeal Mask Airway®Gastro™

Teerthanker Mahaveer Medical College and Research Centre1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年11月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To compare recovery time in both the groups.

研究概览

简要总结

After getting approval from  Institutional Ethical Committee (IEC), those patients who are fit in inclusion criteria will be included in our study and written and informed consent will be taken.

Patient will be randomized in two groups, (40 in each group)  using computer generated random number table.

Group CI – Continuos infusion of propofol using LMA®Gastro™

Group IB – Intermittent Bolus injection of propofol using LMA®Gastro™.

After shifting the patient to endoscopy room, patient will be asked to lie down  supine with head in sniffing position. ASA monitors will be attached. Baseline values of heart rate(HR), systolic blood pressure(SBP),diastolic blood pressure(DBP), and oxygen saturation will be recorded. Patient will be preoxygenated with 100% oxygen for 3 minutes.

Patient will be premedicated with 0.05mg/kg midazolam, 2mcg/kg fentanyl and 0.01mg/kg glycopyrrolate.

In the CI group,  infusion  of propofol will be started at 9-12 mg/kg/hr. Depth of anaesthesia will be assessed by loss of eyelash reflex/verbal contact. After induction, the infusion rate will lowered to the range of 2-5 mg/kg/hr then titrated by 1-2mg/kg/hr to maintain adequate sedation.

In the IB group, patient will be given  intravenous injection bolus 2mg/kg propofol, followed by additional small boluses of 10-20 mg propofol every 30-60 secs to maintain adequate sedation.

Induction time (in minutes) and Total Propofol used for induction (in mg) will be recorded.

Standard insertion technique will be used to insert the LMA®Gastro™ and endoscope, insertion will be performed by an experienced anaesthesiologist and the ease of insertion of the LMA®Gastro™ (Jaw Relaxation, Gagging,Cough,Patient Movement)[10], first attempt success rate of LMA®Gastro™ insertion will be recorded,

Time to insert endoscope via LMA®Gastro™, and Ease of endoscope insertion as rated by gastroenterologist (graded as easy or difficult) will be recorded.

Successful insertion of LMA®Gastro™ was defined by a square wave pattern capnography, symmetrical chest wall expansion and the absence of an audible oral air leak with a cuff pressure between 0-40 cmH20(Yellow zone). If insertion will not successful after two attempts, the trachea will be intubated using direct laryngoscopy and the patient will be excluded from the analysis.

Patient will be ventilated by intermittent  positive pressure ventilation in  supine/ lateral  position. At the end of procedure, the LMA®Gastroâ„¢ will be removed.

The recovery time was defined as the time from stopping propofol till the patient is conscious, alert, obeying command and the airway protective reflexes have returned. Recovery time for successful extubation (in minutes) will be recoded.

Any adverse event like postoperative nausea vomiting ,hypotension, bradycardia,  will be recorded till discharge from PACU.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • Patient giving informed and written consent Age 18-60 years American Society of Anaesthesiologists (ASA) physical status I-II[9] Patient posted for elective ERCP.

排除标准

  • Edentulous patient Mallampati class IV or any Facial deformity H/O Obstructive sleep apnea Allergy to propofol ,lipid emulsion or egg lecithin High risk of aspiration i.e. Gatroesophageal reflux disease Pregnant patients.

结局指标

主要结局

To compare recovery time in both the groups.

时间窗: To compare recovery time in both the groups at 1min,2min,3min,5min,10min,15min,20min,25min and every 5 min afterwards. | To compare the ease of LMA®Gastroâ„¢ insertion in both the group at Jaw relaxation of patient, Gagging cough reflex and Patient Movement

To compare the ease of LMA®Gastro™ insertion in both the groups.

时间窗: To compare recovery time in both the groups at 1min,2min,3min,5min,10min,15min,20min,25min and every 5 min afterwards. | To compare the ease of LMA®Gastroâ„¢ insertion in both the group at Jaw relaxation of patient, Gagging cough reflex and Patient Movement

次要结局

  • To note time to achieve induction and total dose of propofol required in both the groups.

研究者

发起方
Teerthanker Mahaveer Medical College and Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Harshit Dodiya

TMU MEDICAL COLLEGE AND HOSPITAL MORADABAD

研究点 (1)

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