comparing the level of sevoflurane needed for adequate general anaesthesia using 2 different drugs-lignocaine vs morphine
Phase 1
- Conditions
- Health Condition 1: C01- Malignant neoplasm of base of tongueHealth Condition 2: C031- Malignant neoplasm of lower gum
- Registration Number
- CTRI/2023/11/060084
- Lead Sponsor
- AMRITA INSTITUTE OF MEDICAL SCIENCES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
American Society of Anesthesiologists physical status (ASA PS) 2 to 3,
Carcinoma tongue and alveolus undergoing tumor resection surgeries requiring nasal intubation
Exclusion Criteria
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.Timepoint: at start to end of surgery
- Secondary Outcome Measures
Name Time Method 1)comparison of BIS during induction, nasal intubation and anastomosis of free flap, 2)intraoperative changes in heart rate and mean arterial pressure, <br/ ><br>3)consumption of sevoflurane, need for additional analgesic like low dose ketamine or dexmedetomidine, <br/ ><br>4)incidence of hypertension, hypotension, arrhythmia, bradycardia, <br/ ><br>5)intraoperative awareness, <br/ ><br>6)need to stop intravenous lignocaine in OFA patients, 7)need for vasopressors or inotropes in both groups.Timepoint: start of surgery to end of surgery