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CTRI Number  CTRI/2023/11/060084 [Registered on: 21/11/2023] Trial Registered Prospectively
Last Modified On: 14/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparing the level of sevoflurane needed for adequate general anaesthesia using 2 different drugs-lignocaine vs morphine  
Scientific Title of Study   Comparison of endtidal sevoflurane concentration required for optimal depth of anaesthesia during opioid free general anesthesia using intravenous lignocaine versus standard care. 
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 Sunil Rajan 
Designation  Professor 
Affiliation  AMRITA INSTITUTE OF MEDICAL SCIENCES  
Address  Amrita institute of medical sciences, Department of Anaesthesia, A BLOCK, 6TH TOWER 1ST FLOOR, Ponekkara P O. .

Ernakulam
KERALA
682041
India 
Phone  9447464652  
Fax  04842802020  
Email  sunilrajan@aims.amrita.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunil Rajan 
Designation  Professor 
Affiliation  AMRITA INSTITUTE OF MEDICAL SCIENCES  
Address  Amrita institute of medical sciences, Department of Anaesthesia, A BLOCK, 6TH TOWER 1ST FLOOR, Ponekkara P O. .

Ernakulam
KERALA
682041
India 
Phone  9447464652  
Fax  04842802020  
Email  sunilrajan@aims.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri sreekumar  
Designation  student  
Affiliation  AMRITA INSTITUTE OF MEDICAL SCIENCES  
Address  Amrita institute of medical sciences, Department of Anaesthesia, A BLOCK, 6TH TOWER 1ST FLOOR, Ponekkara P O. .

Ernakulam
KERALA
682041
India 
Phone  9947419155  
Fax  04842802020  
Email  gayatrisk_cgnr@hotmail.com  
 
Source of Monetary or Material Support  
Amrita institute of medical sciences, Department of Anaesthesia, A BLOCK, 6TH TOWER 1ST FLOOR, Ponekkara P O. 
 
Primary Sponsor  
Name  AMRITA INSTITUTE OF MEDICAL SCIENCES  
Address  Amrita institute of medical sciences, Department of Anaesthesia, A BLOCK, 6TH TOWER 1ST FLOOR, Ponekkara P O. 
Type of Sponsor  Private 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 GAYATHRI SREEKUMAR  amrita institute of medical sciences   Amrita institute of medical sciences, Department of Anaesthesia, A BLOCK, 6TH TOWER 1ST FLOOR, Ponekkara P O.
Ernakulam
KERALA 		 9947419155
04842802020
gayatrisk_cgnr@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of Amrita school of Medicine   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C031||Malignant neoplasm of lower gum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  comparing of endtidal sevoflurane concentration required for depth of anesthesia in patients between morphine and lignocaine   Group L will receive lignocaine bolus 1.5 mg/kg over 10min followed by infusion lignocaine 1 mg/kg/h throughout the surgery. 
Comparator Agent  comparing the end tidal sevoflurane concentration reuired for optimal depth of anaesthesia in patients receiving morphine   Group B will be given morphine 0.2mg/kg bolus over 10min followed by an infusion of morphine 2mg/h throughout surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists physical status (ASA PS) 2 to 3,
Carcinoma tongue and alveolus undergoing tumor resection surgeries requiring nasal intubation 
 
ExclusionCriteria 
Details  i.Patients with basal HR <60/min,
ii.on beta blockers,
iii.having cardiac arrhythmias, heart blocks, congestive heart failure,
iv.liver disorders with aspartate aminotransferase /alanine transaminase >2-3 times normal
v.renal diseases with estimated glomerular filtration rate <60ml/min/1.73m2
vi.hypersensitivity to lignocaine
vii.awake fiberoptic bronchoscope assisted intubation, 
viii.carcinoma maxilla, craniofacial resection, exenteration, scalp, mastoid and surgeries requiring neuro assistance
ix.supplemental regional anaesthesia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary objective is to compare the endtidal sevoflurane concentration required to maintain intraoperative bispectoral index (BIS) values between 40 to 60 au in patients receiving opioid free anesthesia (OFA) using intravenous lignocaine versus standard regimen using morphine during tumor resection in patients with head and neck malignancies undergoing wide excision and reconstruction surgeries.  at start to end of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
1)comparison of BIS during induction, nasal intubation and anastomosis of free flap, 2)intraoperative changes in heart rate and mean arterial pressure,
3)consumption of sevoflurane, need for additional analgesic like low dose ketamine or dexmedetomidine,
4)incidence of hypertension, hypotension, arrhythmia, bradycardia,
5)intraoperative awareness,
6)need to stop intravenous lignocaine in OFA patients, 7)need for vasopressors or inotropes in both groups. 		 start of surgery to end of surgery  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 1 
Date of First Enrollment (India)   01/12/2023 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary   This is a prospective randomized single blinded study.There will be 2 group of patients . Groupl L will receive lignocaine at a bolus dose of 1.5mg/kg followed by a infusion dose of 1mg/kg/hour and group b will receive morphine at dose of 0.2mg/kg followed by an infusion dose of 2mg/hr .The primary objective is to compare the end tidal sevoflurance concentration required for optimal depth of anaesthesia in patients receiving lignocaine and standard morphine in patients with head and neck malignancies undergoing tumour resection and reconstructive surgeries to maintain an intraoperative BIS between 40 to 60 . The secondary objectives include comparison of BIS during induction, nasal intubation and anastomosis of flap, intraoperative changes in heart rate, mean arterial pressure ,consumption of sevoflurane,need for additional analgesics , incidence of hypertension/bradycardia/hypotension/arrhthymia,recall of events on 2nd post operative day and need to stop opioid free analgesics. Data from both groups will be compared. 
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