跳至主要内容
临床试验/CTRI/2024/06/069009
CTRI/2024/06/069009尚未招募不适用

Comparison of anosmic effect of inhalational agents and total intravenous anaesthesia - a prospective randomized study

Mahatma Gandhi Medical College and Research Institute Pondicherry1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年6月26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
52
试验地点
1
主要终点
Sense of smell of patients undergoing surgery under general anaesthesia and total intravenous anaesthesia

研究概览

简要总结

COMPARISON OF ANOSMIC EFFECT OF INHALATIONAL AGENTS AND TOTAL INTRAVENOUS ANAESTHESIA -A PROSPECTIVE COMPARATIVE STUDY

Study population:

All patients who will be undergoing elective surgery under general anaesthesia(GROUP-G)and Total Intravenous Anaesthesia (TIVA)(GROUP-T).

Study setting:Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute.

 Study period*:*After obtaining ethical clearance from the IHEC.

Inclusion and exclusion criteria:

Inclusion criteria:

1.     Patient should be in the age of 18-60years

2.     Patient to get fit under ASA 1andASA2

3.     Patient should undergo elective surgery under general anaesthesia and Total Intravenous Anaesthesia (TIVA).

 Exclusion criteria:

1.     Patient with history of anosmia.

2.     Patients who are potential for difficult airway management.

3.     Patient with history of preoperative URI or LRI within 14 days of recovery.

4.     Patients with severe hepatic or renal failure , allergy to medications of the study, BMI>30.

5.     Pregnant female

6.     Patient allergic to egg.

7.     Patient who  refused to give consent.

 After satisfying the inclusive and exclusive criteria , written informed consent will be

taken from the study participants. After informed consent the participants would made comfortable and made self test the odorants. Check both nostrils of the patient. Patient will be  asked to close both their eyes and one nostril and now the patient will be asked to sniff one of the Indian spices like clove oil & asafetida and identify. After one min patient will be asked to sniff coffee been seed in order to neutralize the previous odor of Indian spice and after another one min patient Will be asked to sniff another Indian spice. Repeat the procedure on other nostril. This will be done preoperatively and postoperatively after elective surgeries  under general anaesthesia(GROUP-G)and  total intravenous  anaesthesia(GROUP-T)

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

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 should be in the age of 18-60 years
  • Patient to go fit under ASA1 and ASA2
  • Patient should undergo elective surgery under inhalation agent and total intravenous anaesthesia.

排除标准

  • Patient with history of anosmia Patient who are potential for difficult airway management Patient with the history of URI and LRI Patient allergic to egg Patient who has refused to give consent.

结局指标

主要结局

Sense of smell of patients undergoing surgery under general anaesthesia and total intravenous anaesthesia

时间窗: 1st, 3rd, 5th, 7th and 9th hours of postoperatively

次要结局

  • Time taken for recovery of smell sensation(1st, 3rd, 5th, 7th and 9th hours of postoperatively)

研究者

发起方
Mahatma Gandhi Medical College and Research Institute Pondicherry
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

M Aarthi

Mahatma Gandhi Medical College and Research Institute

研究点 (1)

Loading locations...

相似试验