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Effects of Minimal-Flow Sevoflurane and Multimodal Analgesia in Head and Neck Cancer Surgery

ConditionsHead and Neck CancerAnesthesiaRenal ProtectionAcute Kidney InjuryMultimodal Analgesia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorNational Taiwan University Hospital

About this trial

This study evaluates the anesthetic-sparing and renal protection effects of minimal-flow sevoflurane anesthesia combined with multimodal analgesia using dexmedetomidine, ketamine, and lidocaine in head and neck cancer patients undergoing free flap microvascular surgery. The 2x2 factorial randomized controlled trial aims to compare sevoflurane usage and renal function changes with different fresh gas flow rates and multimodal analgesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-99 years

Scheduled for head and neck cancer tumor resection and free flap reconstruction surgery

Disqualifiers

Preoperative tracheostomy

History of previous head and neck cancer tumor resection

Anemia (hematocrit <30% or recent transfusion)

Hypertension on ACEI/ARB medications

Trial design

Design model

Factorial

Treatments tested in this trial

  • Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture

    Drug

    Multimodal analgesia using dexmedetomidine-ketamine-lidocaine mixture vs placebo normal saline

  • Minimal flow sevoflurane

    Device

    Minimal flow sevoflurane anesthesia (0.5 L/min) vs low flow sevoflurane (1 L/min)

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Group 1 (HL-D)Experimental treatment 2 interventions
Group B: Group 2 (HL-ND)Experimental treatment 1 intervention
Group C: Group 3 (L-D)Experimental treatment 1 intervention
Group D: Group 4 (L-ND)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Sevoflurane usage (mL/h)

Volatile anesthetic consumption hourly

Time frame
Intraoperative period
2

Renal function

Changes in renal function (serum renin, AVP levels, urine KIM-1, NGAL levels)

Time frame
Perioperative period

Secondary outcomes

1

Acute kidney injury

Incidence of acute kidney injury

Time frame
Perioperative period
2

Hemodynamic stability_1

Hemodynamic stability, present as heart rate fluctuation

Time frame
Intraoperative period
3

Hemodynamic stability_2

Hemodynamic stability, present as blood pressure fluctuation

Time frame
Intraoperative period
4

Hemodynamic stability_3

Hemodynamic stability, present as vasoactive drug amount of usage

Time frame
Intraoperative period

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: