comparing the level of sevoflurane needed for adequate general anaesthesia using 2 different drugs-lignocaine vs morphine

Comparison of endtidal sevoflurane concentration required for optimal depth of anaesthesia during opioid free general anesthesia using intravenous lignocaine versus standard care. - nil

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/060084

Enrollment

Registered

2023-11-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C031- Malignant neoplasm of lower gum

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

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

Exclusion criteria: i.Patients with basal HR 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 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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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.Timepoint: start of surgery to end of surgery	—

Measure

Time frame

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.Timepoint: start of surgery to end of surgery

—

Countries

India

Contacts

Public ContactDr Gayathri sreekumar

AMRITA INSTITUTE OF MEDICAL SCIENCES

sunilrajan@aims.amrita.edu9447464652

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026