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临床试验/CTRI/2024/11/077152
CTRI/2024/11/077152尚未招募不适用

POST-OPERATIVE SORE THROAT: COMPARING KINGVISION VIDEO LARYNGOSCOPE AND MACINTOSH LARYNGOSCOPE FOR ADULT PATIENTS REQUIRING TRACHEAL INTUBATION.

Kodagu Institute Of Medical Sciences and Teaching Hospital Madikeri1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
To compare incidence of postoperative sore throat(POST) after laryngoscopy and intubation using Macintosh laryngoscope and Kingvision video laryngoscope

研究概览

简要总结

POST-OPERATIVE SORE THROAT: COMPARING KINGVISION VIDEO LARYNGOSCOPE AND MACINTOSH  LARYNGOSCOPE FOR ADULT PATIENTS REQUIRING TRACHEAL  INTUBATION.

On previous day of surgery, all patients will have pre anesthetic evaluation. Patient’s airway will be evaluated using modified Mallampati classification and airway evaluating parameters like inter incisor distance, thyromental distance, sternomental distance. Patients who meet the inclusion criteria will be randomly assigned to two equal groups.

Group MCL: Endotracheal intubation done using Macintosh laryngoscope.

Group VDL : endotracheal intubation done using king vision video laryngoscope

On the day before surgery the patients will be explained how to rate the severity of   POST  by using a 04 point scale (0-3).The incidence of  POST Will be recorded using a yes/no questionnaire.  On the day of surgery, written informed consent will be obtained from all patients. Patient shifted to Operation theatre and standard multipara monitors are connected. IV access with 20G cannula will be established. Patients will be premedicated with injection injection Midazolam 0.02mg/kg , injection Fentanyl 2mcg/kg induction with injection Propofol 1-2 mg/kg , muscle relaxant with Vecuronium 0.1mg/kg. Patient in group MCL will be intubated with laryngoscope size 3 or 4 blade. Similarly, patients in group VDL Size 4 reusable blade will be used. Patients will be intubated with 7 and 8 mm endotracheal tube in women and men respectively. Pressure will be maintained between 20-25 cm of water, measured using portex cuff manometer. . Once the patient is intubated the observer will enter the Operation Theatre. General Anaesthesia will be maintained by 2% Sevoflurane  on completion of surgery reversal with mixture of inj. Neostigmine 0.05mg/kg and Glycopyrolate 0.01mg/kg will be administered. Post extubation vitals noted. Once the patient is shifted to Post Anaesthesia Care Unit, patient will be asked by observer about incidence of POST and will be labelled as time 0 hr. Then, at 1st hour,6th hour,12thhour and at 24th hour.

The data collected will be summarized and compiled. It will be entered into Microsoft Excel spreadsheet and then exported to data editor of SPSS version 26.0.Results will be expressed using charts and tables.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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

  • Patients undergoing surgery under general anesthesia 1.ASA PS grade 1 and 2 2.Mallampati classification 1 and 2 3.BMI less than 30kg/m2.

排除标准

  • 1.Duration of surgery more than 4 hours 2.Recent upper respiratory tract infection 3.Patients requiring throat pack insertion.

结局指标

主要结局

To compare incidence of postoperative sore throat(POST) after laryngoscopy and intubation using Macintosh laryngoscope and Kingvision video laryngoscope

时间窗: Incidence of sore throat- At 0th ,1st, 6th , 12th , 24th hour

次要结局

  • The severity of POST during first 24hours after surgery.(Severity of sore throat-At 0th, 1st, 6th , 12th , 24th hour)

研究者

发起方
Kodagu Institute Of Medical Sciences and Teaching Hospital Madikeri
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr PRIYANKA N H

KODAGU INSTITUTE OF MEDICAL SCIENCES AND TEACHING HOSPITAL,MADIKERI

研究点 (1)

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