Comparision between Etomidate infusion and propofol infusion in head and neck onco surgeries

Not yet recruiting

• Conditions: Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,

• Registration Number: CTRI/2021/12/038938
• Lead Sponsor: Shree Krishna Hospital

Brief Summary

After obtaining ethical committee approval & obtaining patients written informed consent, patients of ASA- II, III and IV Physical status who are undergoing Head and Neck Onco surgeries will be recruited to participate in the randomized trial and participant would be randomly allocated to ES or PS group.

Pre operatively an intravenous cannula will be inserted; a fluid load of 10ml/kg of crystalloid solution will be administered intravenously prior to induction. All patients will be prepared with Lignocaine gargles, 10% Lignocaine spray puffed on posterior pharyngeal wall, 4% Lignocaine nebulisation. Lastly after giving headup position and starting Oxygen via nasal prongs, nasal cavity with be packed with nasal wicks soaked in 1 ampoule of Adrenaline+ 4% Lignocaine+ 8-10 drops of Xylometazoline. Inj. Dexmedetomidine (0.5mcg/kg) I.V in loading dose through infusion will be started in all the patients 10 minutes before induction followed by maintenance dose of 0.2-0.7 mcg/kg intraoperatively according to haemodynamics.

Routine monitoring ECG, Manual BP, NIBP, and pulse oximetry, ET CO2, will be done intra operatively.



All patients will be pre-medicated with IV Inj. Glycopyrrolate (0.004 mg/kg) IV, Inj. Fentanyl (2 microgram/kg) intravenously slowly and Inj. Lignocaine (preservative free) IV will be given. After preoxygenation with 100% Oxygen through closed circuit for 5 minutes, patients will be induced with IV Inj. Propofol 2mg/kg or Inj. Etomidate 0.2 mg/kg intravenously After check ventilation, adequate muscle relaxation will be achieved with Inj. Succinylcholine (2 mg/kg) intravenously. Nasal dilatation will be achieved with appropriate dilator and a Flexometallic endotracheal tube will be inserted through nasal cavity which will be further negociated with help of laryngoscope. Cuff will be inflated with air, bilateral air entry will be checked and confirmed and tube fixed at the nasal bridge. Long acting muscle relaxant Inj. Vecuronium 0.1mg/kg IV will be given. Patients will be maintained on inhalational agent Sevoflurane, Oxygen and Air through closed circuit using controlled ventilation.

Simultaneously at maintenance doses Inj. Propofol (80 mcg/kg/min) or Etomidate(10mcg/kg/min) infusion will be started in PS and ES groups respectively and will be continued till the excision of primary tumour and neck dissection has been completed. Haemodyanamic parameters will be monitored and muscle relaxing agent using peripheral nerve stimulator with train of four) will be given accordingly intraoperatively.

I) Hemodynamic stability assessed by

HR

BP

ECG

SP02

ETCO2

Total volume of blood and blood products given, if any

Any new event and intervention done for it, if any

A decrease of >20% in blood pressure from baseline will be defined as hypotension.

A decrease of >20% in heart rate from baseline will be defined as bradycardia.

(II) Requirement of inhalational agent

A. Dial concentration

B. Fresh gas flow

C. Exact duration of surgery



(III) Side Effects will be assessed by the following parameters

A. Nausea and Vomiting

B. Thrombophlebitis

C. Hypotension

D. Myoclonus

E. Any other event

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-12-24
• Study Start: 2021-12-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1)Patients of ASA II, III and IV Physical status 2)Age 30-70 years of either gender 3)Patients undergoing Head and Neck Onco surgeries.

Exclusion Criteria

1)patient refusal 2)Hypersensitivity to active substance or any of its excipients 3)Renal insufficiency 4)Patients with history of convulsion 5)Patients in sepsis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)To assess hemodynamic stability in patients undergoing Head and Neck Onco surgery with etomidate infusion and compare it with propofol infusion during maintenance of anesthesia	0mins, 5 mins, 10mins, 15mins.......
2)To assess and compare post operative recovery in these two group of patients	0mins, 5 mins, 10mins, 15mins.......

Secondary Outcome Measures

Name	Time	Method
To assess the requirement of inhalational agent, sevoflurane with etomidate and propofol infusion respectively

Trial Locations

Locations (1)

Shree Krishna Hospital; 🇮🇳 Anand, GUJARAT, India

Shree Krishna Hospital

🇮🇳Anand, GUJARAT, India

Amee Thesia

Principal investigator

9714332686

ameemt1904.at@gmail.com