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CTRI Number  CTRI/2024/03/064653 [Registered on: 22/03/2024] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of anaesthetic drug combinations to study better relaxation  
Scientific Title of Study   Fentanyl and propofol versus fentanyl and etomidate for the insertion conditions of laryngeal mask airway:A prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita verma 
Designation  junior resident 
Affiliation  Mahatma Gandhi Memorial Medical College 
Address  Department of Anaesthesiology, Maharaja Yashwant Rao Hospital and Mahatma Gandhi Memorial Medical College, Indore, Madhya Pradesh
Indore
Indore
MADHYA PRADESH
452001
India 
Phone  8894923612  
Fax    
Email  anksv2261@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepali Valecha 
Designation  Assistant professor  
Affiliation  Mahatma Gandhi Memorial Medical College, Indore  
Address  Department of Anaesthesiology, Maharaja Yashwant Rao Hospital and Mahatma Gandhi Memorial Medical College Indore madhya pradesh

Indore
MADHYA PRADESH
452001
India 
Phone  9424405405  
Fax    
Email  deepalisidhwani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepali Valecha 
Designation  Assistant professor  
Affiliation  Mahatma Gandhi Memorial Medical College, Indore  
Address  Department of Anaesthesiology, Maharaja Yashwant Rao Hospital and Mahatma Gandhi Memorial Medical College Indore madhya pradesh

Indore
MADHYA PRADESH
452001
India 
Phone  9424405405  
Fax    
Email  deepalisidhwani@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, MY hospital and MGM college, Indore 
 
Primary Sponsor  
Name  Mahatma Gandhi Memorial Medical College and Maharaja Yashwantrao Hospital 
Address  Department of Anaesthesiology Mahatma Gandhi Memorial Medical College and Maharaja Yashwantrao hospital, Indore, Madhya Pradesh, pin code 452001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ankita verma  Maharaja Yashwant Rao Hospital and Mahatma Gandhi Memorial Medical College Indore madhya pradesh   Ground floor, OT complex, department of Anaesthesiology office, MY hospital
Indore
MADHYA PRADESH 
8894923612

anksv2261@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics and scientific review committee M.G.M. medical college & M.Y. hospital, indore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fentanyl and etomidate  Induction of anaesthesia will be achieved with Inj.fentanyl @2mcg/kg + inj.etomidate @0.3mg/kg. If adequate relaxation is not achieved with initial bolus dose, an additional bolus dose of etomidate with 0.15mg/kg will be given. Total drug dose required will be noted. 
Intervention  Fentanyl and propofol  Induction of anaesthesia will be achieved with Inj. Fentanyl @2mcg/kg+ Inj. Propofol @2mg/kg. If adequate relaxation is not achieved with initial bolus dose, an additional bolus dose of propofol with 1mg/kg will be given. Total drug dose required will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade 1 and 2
Patient with planned short surgical procedures and day care surgeries (upto 1.5 hours) 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  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  
 
Secondary Outcome  
Outcome  TimePoints 
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  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   29/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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 

6. 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 
3. 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. )
4. 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
5. 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.
6. 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
7. 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
8. 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.
9. 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.
10. 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.


 
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