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临床试验/CTRI/2019/08/020691
CTRI/2019/08/020691已完成不适用

A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY OF I-GEL VERSUS BASKA MASK IN PATIENTS RECEIVING GENERAL ANAESTHESIA

pondicherry institute of medical sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年8月16日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
To evaluate igel and baska mask’ oropharyngeal sealing pressure (OSP)

研究概览

简要总结

TITLE

A PROSPECTIVE RANDOMIZED COMPARATIVE STUDY OF I-GEL VERSUS BASKA MASK IN PATIENTS RECEIVING GENERAL ANAESTHESIA

SUMMARY

TYPE OF STUDY:

A Prospectiverandomized comparative study.

STUDY POPULATION:

Patients postedfor elective surgeries under general anaesthesia lasting for 1 to 3 hours at PIMSwere included in our study.

SAMPLE SIZE:

Fifty patients wererandomized into two groups of twenty five each.

PERIOD OF STUDY:

October 2018 toApril 2020.

OBJECTIVES:

1.   To evaluate theoropharyngeal sealing pressure (OSP) of i-gel and baska mask.

2.   The ease ofinsertion (assessed by the duration of time taken to insert them successfullyand the number of insertion attempts).

3.   To determine thesuccess rate of insertion based on positioning of the i-gel and baska maskconfirmed by boroscope.

4.   To detect thehemodynamic responses induced by airway insertion (blood pressure, heart rate,oxygen saturation and end-tidal carbon dioxide (EtCO2).

5.   The incidence ofpostoperative complications such as the presence of laryngospasm on emergence,blood on the mask, sore throat.

METHODS:

Fiftypatients posted for elective surgery under General Anaesthesia lasting for 1 to3 hours were enrolled and randomized into two groups I and B.

1.    Group I – I gel was used

2.    Group B – Baska mask was used

OUTCOME MEASURES:

1.    Oropharyngeal Sealing Pressure

2.    Number of Attempts

3.    Grade of Ease of Insertion

4.    Duration of Insertion

PARAMETERS MONITORED:

The following parameters were recorded at thetime of insertion and every minute for the first 5 minutes and then, every5mins for 15 minutes after successful insertion-

1.    Heart and Blood pressure

2.    EtCO2 and SpO2

The following parametersare noted after extubation–

1.    Laryngospasm

2.    Blood staining on the device or in mouthduring suction.

3.    Sore throat at half an hour after extubation,2nd hour, 4th hour, 6th hour and 24 hours.

RESULTS:

·       The Oropharyngeal Sealing Pressure was morewith Group B (29.4 cm of H2O) than Group I (26.32 cm of H2O).

·       Number of Attempts of Insertion and Grade ofEase of Insertion in both the groups were similar and had no statisticaldifference.

·       Mean duration of insertion was less in Group I(13.28 s) than Group B (13.80 s), but statistically not significant.

·       Parameters like blood pressure, heart rate,SpO2 and ETCO2 were compared and no statisticaldifference.

·       No complications occurred in either group.

CONCLUSION

•       Oropharyngealsealing pressure with Baska mask was better when compared with I gel (P <0.042).

•       Time taken toinsert was similar in both the groups.

•       But ease ofinsertion and number of attempts of insertions were similar in both the groups.

•       There was nohaemodynamic changes in both the groups within the study period.

•       There were nocomplications with either of the SAD’s.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • 1.Patients coming under American Society of Anesthesiologists grade I or II ASA I- Normal healthy individuals ASA II-Patient with mild systemic disease well compensated which include current smoker, mild lung disease, social drinker, well controlled Diabetes mellitus and hypertension.
  • 2.Age : above 18 yrs.
  • and below 65yrs 3.Mallampati grade I & II.
  • 4.Surgeries lasting for 1 to 3 hours (like short gynaecologic procedures, hernioplasties, incision and drainage and fibroadenoma excision.).

排除标准

  • 1.Emergency surgeries 2.Patients with known gastrointestinal reflux, sore throat, upper respiratory airway infections.

结局指标

主要结局

To evaluate igel and baska mask’ oropharyngeal sealing pressure (OSP)

时间窗: 2021 may

次要结局

  • 1.The ease of insertion.(2.To determine the success rate of insertion based on positioning of the igel and baska mask)

研究者

申办方类型
Private medical college

研究点 (1)

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