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CTRI Number  CTRI/2024/04/064980 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 23/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of study drugs fentanyl, dexmedetomidine and lidocaine on extubation quality and the changes in the blood pressure, heart rate and oxygen saturation. 
Scientific Title of Study   Effect on quality of extubation and hemodynamic response - comparison between fentanyl, dexmedetomidine and lidocaine, a prospective randomised 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  Dr Moguram Soumya 
Designation  PG student anaesthesia  
Affiliation  nizams institute of medical sciences 
Address  Speciality block operation theatre Department of anaesthesia nizams institute of medical sciences Punjagutta

Hyderabad
TELANGANA
500082
India 
Phone  7989313628  
Fax    
Email  Soumyamoguram123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr ARCHANA PATHY 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Nizams institute of medical sciences 
Address  Department of anaesthesia Speciality block operation theatre Nizams institute of medical sciences Punjagutta

Hyderabad
TELANGANA
500086
India 
Phone  8885494278  
Fax    
Email  docarchana.pathy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Moguram Soumya 
Designation  PG STUDENT 
Affiliation  nizams institute of medical sciences 
Address  Department of anaesthesia Speciality block operation theatre Nizams institute of medical sciences Punjagutta Hyderabad

Hyderabad
TELANGANA
500082
India 
Phone  7989313628  
Fax    
Email  Soumyamoguram123@gmail.com  
 
Source of Monetary or Material Support  
nizams institute of medical sciences Punjagutta Hyderabad Telangana India 500082 
 
Primary Sponsor  
Name  MOGURAM SOUMYA 
Address  Nizams institute of medical sciences Punjagutta Hyderabad India 500082 
Type of Sponsor  Other [self funding] 
 
Details of Secondary Sponsor  
Name  Address 
Prachi kar  Nims hospital, Punjagutta, Hyderabad  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Moguram Soumya   Nizams institute of medical sciences  Department of anaesthesia Speciality block Punjagutta Hyderabad, 500082
Hyderabad
TELANGANA 		 7989313628

Soumyamoguram123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS INSTITUTIONAL ETHICS COMMITTE  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 
Intervention  Dexmedetomidine and lidocaine  Using fentanyl as a standard of care the drugs are compared for extubation response. After the MAC is zero, one group of patients will be given dexmedetomidine (0.5micrograms/kg) IV and another group of patients will be given Lidocaine (1.5milligrams/kg) IV and seen for response using quality extubation score, ramsay sedation score, grading of airway reflexes and hemodynamics at eight different intervals as mentioned in the time points section above. 
Comparator Agent  Fentanyl  Fentanyl in this study is the standard of care. At the end of the procedure skin will be infiltrated with 0.25% bupivacaine, inhalational agents will be stopped and fentanyl (0.5 micrograms/kg) bolus will be given after the Minimum alveolar concentration(MAC) is zero and Train of four(TOF) more than 0.5.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I and II
Posted for elective laparoscopic cholecystectomy  
 
ExclusionCriteria 
Details  BMI more than 30 kg/m2
Predicted airway difficulty
Significant comorbidities
Patients on heart rate control drugs
History of recent upper respiratory tract infections
Local anaesthetic allergy
Coagulation abnormalities
Not willing for consent  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
ASSESSMENT OF QUALITY OF EXTUBATION, AIRWAY RESPONSE AND HEMODYNAMIC RESPONSE IS THE PRIMARY OUTCOME OF THE STUDY.  BASELINE VITALS
A0 (just before the study drug administration)
A1 (one minute after study drug administration)
A5 (five minutes after study drug administration)
E0 (before extubation)
E1 (one minute after extubation)
E5 (five minutes after extubation)
E10 (ten minutes after extubation) 
 
Secondary Outcome  
Outcome  TimePoints 
To assess for adverse effects like sedation, respiratory depression, hypotension and Bradycardia  1 year 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   01/06/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [soumyamoguram123@gmail.com].

  6. For how long will this data be available start date provided 01-03-2024 and end date provided 02-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   I have received approval from institutional research committee and institutional ethics committee following the approval of ctri I want to go ahead with the recruitment. 
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