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临床试验/CTRI/2024/03/064653
CTRI/2024/03/064653进行中(未招募)4 期

Fentanyl and propofol versus fentanyl and etomidate for the insertion conditions of laryngeal mask airway:A prospective observational study

Mahatma Gandhi Memorial Medical College and Maharaja Yashwantrao Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月29日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
To assess insertion condition of laryngeal mask airway in terms of number of attempts required ,time required to insert LMA, ease of insertion of LMA

研究概览

简要总结

Introduction

Nowadays regional anaesthesia (various blocks) are being very commonly used along with sedation. Sometimes there arises a need to secure airway in maintaining spontaneous ventilation of the patients. In such scenarios Laryngeal mask airway(LMA) , a supraglottic device is the most preferred device used for airway management in day care surgeries. Smooth and successful insertion of LMA requires an adequate mouth opening and minimised airway reflexes.

Commonly used agents for induction of anaesthesia through LMA include propofol alone and in combination with opioids like fentanyl, butorphanol, muscle relaxants such as mivacurium, atracurium . Other drugs such as midazolam, clonidine, dexemedetomidine, ketamine and lignocaine can also be used.

So far LMA insertion has been facilitated using propofol either with ketamine or fentanyl and various studies have been done to compare the above two combinations . It has been found that fentanyl and propofol combination gives better insertion conditions for LMA as compared to ketamine propofol combination. But the combination of fentanyl and propofol is associated with bradycardia and hypotension therefore it needs to be avoided in cardiovascular-compromised patients. So, it is hypothesized whether a combination of fentanyl and etomidate would provide as good insertion conditions as that of fentanyl and propofol. Thus, with such considerations, the present study has been undertaken to compare the two combinations for insertion conditions of LMA.

Methodology

The present study will be conducted in THE DEPARTMENT OF ANAESTHESIOLOGY , M.Y. HOSPITAL AND MGM MEDICAL COLLEGE INDORE M.P.

Prior to the procedure, pre anaesthetic checkup will be done and Written informed consent will be obtained from the patients for participation in the study after explaining procedure in their local language.

Patient will be advised to be kept nil oral for 6 hours before surgery.

The patient will be allotted to either group A or group B using computer generated randomization table .

In the operation theatre standard monitors (electrocardiogram, noninvasive blood pressure, pulse oximeter and EtCO2) will be attached to the patient and baseline parameters will be recorded .

IV access will be secured using 20G cannula.

Ringer lactate @10ml/Kg will be used to preload the patient.

Patient will be premedicated with inj. glycopyrolate 10µg/kg and inj. midazolam 0.02mg/Kg

Patients will be preoxygenated with 100% oxygen for 3minutes using Bains circuit.

Induction of Anaesthesia will be achieved with Inj. fentanyl (2mcg/kg) + propofol (2mg/kg) intravenously in group A and Inj. fentanyl(2mcg/kg) + etomidate(0.3mg/kg) in group B intravenously.

Once adequate relaxation is achieved, appropriated size classic LMA will be inserted as per standard technique by an experienced anaesthesiologist (>3yrs of experience) and successful insertion will be confirmed using capnography. The insertion conditions will be recorded in terms of-

  1. number of attempts required

  2. time required to insert LMA

  3. ease of insertion of LMA

If ,adequate relaxation is not achieved with initial bolus dose, an additional bolus doses of propofol with 1mg/kg and etomidate with 0.15mg/kg will be given in the respective groups. Total drug dose required will be noted.

Anaesthesia will be maintained by O2 50% +N2O 50% + sevoflurane @2 MAC.

Hemodynamic parameters will be recorded at baseline, after induction, immediately after LMA insertion, at 1 minute, at 3 minutes, at 5minutes and at 10 minutes after LMA insertion and there after every 5mins till end of surgery

Any of Adverse effects as mentioned in table 4 and 5 ,will be recorded and treated as per standard protocol.

If, >2 attempts to insert LMA are required, case will be excluded from the study.

Observation Tables

1.Demographic details

 Group A/B
 Age (years)
 Sex
 Weight (kg)
 Height (m)
 ASA grade
 Mallampati grade

2.Insertion conditions

 Group A/B
 Number of attempts required
 Total time taken (in second)
 Ease of insertion (easy/ difficult)

3.Hemodynamic parameters

 HR spO2 MAP EtCO2
 Baseline
 After induction
 After 1 min.
 After 3 min
 After 5 min
 After 10 min
 Every 5 minute till  end of surgery

4.Complications related to study drugs

 Group A/ B
 Hypotension
 Bradycardia
 Apnoea
 Myoclonus

5.Complications related to airway manipulation

 Group A/B
 Inadequate jaw relaxation
 Gagging
 Coughing
 Limb movement
 Laryngospasm
  1. Drug dose required
 Group A (propofol)/ group B (etomidate)
 Total dose of drug Required(mg)

References

  1. S¸ Uzun, A Gözaçan, Ö Canbay et al.,Remifentanil for insertion of a laryngeal mask airway.. Department of Anaesthesiology and Reanimation, Faculty of Medicine, Hacettepe University, Ankara, Turkey ,the Journal of International Medical Research , 2007.

2.Aberra et al. Effect of ketofol versus propofol as an induction agent on ease of laryngeal mask airway insertion conditions and hemodynamic stability in pediatrics: an observational prospective cohort study, BMC Anesthesiology (2019) 19: 19:41

  1. P. K. Goh, C. L. Chi, C. Y. Wang, Y. K. Chans and P. L. Loo, “Randomized Double Blind Comparison of Ketamine-Propofol, Fentanyl-Propofol and Propofol-Saline on Hemodynamics and Laryngeal Mask Airway Insertion Conditions,” (Anaesthesia and Intensive Care, Vol. 33, No. 2, 2005, pp. 223-228. )

  2. Hashaam B. Ghafoor, Gauhar Afshan, Rehana Kamal, General Anesthesia with Laryngeal Mask Airway: Etomidate vs Propofol for Hemodynamic Stability Open Journal of Anesthesiology, 2012, 2, 161-165 doi:10.4236/ojanes.2012.24036 Published Online September 2012 (http://www.SciRP.org/journal/ojanes) 161

  3. Gupta A, Kaur S, Attri JP, Saini N. Comparative evaluation of ketamine-propofol, fentanyl-propofol and butorphanol-propofol on haemodynamics and laryngeal mask airway insertion conditions. J Anaesthesiol Clin Pharmacol. 2011;27(1):74.

  4. Ghatak T, Singh D, Kapoor R, Bogra J. Effects of addition of ketamine, fentanyl and saline with Propofol induction on hemodynamics and laryngeal mask airway insertion conditions in oral clonidine premedicated children. Saudi J Anaesth. 2012;6(2):140

  5. Ozgul U, Begec Z, Karahan K, Erdogan MA, Aydogan MS, Colak C, et al. Comparison of propofol and ketamine-propofol mixture (Ketofol) on laryngeal tube-suction II conditions and hemodynamics: a randomized, prospective, double-blind trial. Curr Ther Res. 2013;75:39–43

  6. Ghafoor HB, Afshan G, Kamal R. General anesthesia with laryngeal mask airway: etomidate vs propofol for hemodynamic stability. Open J Anesthesiol. 2012;2(4):161–5.

  7. Seyedhejazi M, Eydi M, Ghojazadeh M, Nejati A, Ghabili K, Golzari SE, et al. Propofol for laryngeal mask airway insertion in children: effect of two different doses. Saudi J Anaesth. 2013;7(3):266.

  8. Liou CM, Hung WT, Chen CC, et al: Improving the success rate of laryngeal mask airway insertion during etomidate induction by using fentanyl or succinylcholine. Acta Anaesthesiol Taiwan 2004; 42: 209 – 213.

研究设计

研究类型
Interventional
分配方式
Randomized
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

  • ASA grade 1 and 2 Patient with planned short surgical procedures and day care surgeries (upto 1.5 hours).

排除标准

  • Refusal to give consent or known allergy to any of the study drugs or Anticipated difficult airway or Relative or absolute Contraindation for laryngeal mask airway.

结局指标

主要结局

To assess insertion condition of laryngeal mask airway in terms of number of attempts required ,time required to insert LMA, ease of insertion of LMA

时间窗: Hemodynamic parameters will be recorded at baseline, after induction, at 1minute, at 3 minute, at 5 minute and there after every 5 minutes till end of surgery

次要结局

  • To compare hemodynamics of two study groups(Hemodynamic parameters will be recorded at baseline, after induction, at 1minute, at 3 minute, at 5 minute and there after every 5 minutes till end of surgery)

研究者

发起方
Mahatma Gandhi Memorial Medical College and Maharaja Yashwantrao Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Ankita verma

Mahatma Gandhi Memorial Medical College

研究点 (1)

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