| CTRI Number |
CTRI/2021/12/038938 [Registered on: 27/12/2021] Trial Registered Prospectively |
| Last Modified On: |
24/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Comparision between Etomidate infusion and propofol infusion in head and neck onco surgeries |
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Scientific Title of Study
|
Comparative study between Etomidate infusion versus Propofol infusion as maintenance of anesthesia for hemodynamic stability and recovery in Head and Neck Onco surgeries
|
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alpa Patel |
| Designation |
Professor |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department of Anaesthesia
Pramukhswami Medical College and Shree Krishna Hospital Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9825084282 |
| Fax |
|
| Email |
alpamp@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amee Thesia |
| Designation |
Resident doctor |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department of Anaesthesia
Pramukhswami Medical College and Shree Krishna Hospital Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9714332686 |
| Fax |
|
| Email |
ameemt1904.at@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amee Thesia |
| Designation |
Resident doctor |
| Affiliation |
Pramukhswami Medical College |
| Address |
Department of Anaesthesia
Pramukhswami Medical College and Shree Krishna Hospital Karamsad
Anand
GUJARAT
388325
India |
| Phone |
9714332686 |
| Fax |
|
| Email |
ameemt1904.at@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Shree Krishna Hospital |
| Address |
Karamsad, Anand, Gujarat |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amee Thesia |
Shree Krishna Hospital |
Department of Anaesthesia
Pramukhswami Medical College, Karamsad, Anand, Gujarat
Anand
GUJARAT |
9714332686
ameemt1904.at@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| H.M.Patel Center forMedical Care andEducation |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (2) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etomidate |
Etomidate infusion will be started for maintenance anesthesia at 10mcg/kg/min and hemodynamic parameters, post op recovery and sevoflurane required will be noted and these parameters will compared with those in propofol infusion started for maintenance anesthesia at 80mcg/kg/min Continuous infusion of either agents in respective participants will be started after induction for maintenance anesthesia and continued till primary tumor excision and neck dissection is completed (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 |
| Comparator Agent |
Propofol |
Etomidate infusion will be started for maintenance anesthesia at 10mcg/kg/min and hemodynamic parameters, post op recovery and sevoflurane required will be noted and these parameters will compared with those in propofol infusion started for maintenance anesthesia at 80mcg/kg/min
Continuous infusion of either agents in respective participants will be started after induction for maintenance anesthesia and continued till primary tumor excision and neck dissection is completed
(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 |
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
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
2)To assess and compare post operative recovery in these two group of patients |
0mins, 5 mins, 10mins, 15mins....... |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the requirement of inhalational agent, sevoflurane with etomidate and propofol infusion respectively
|
0mins, 5 mins, 10mins, 15mins....... |
|
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Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2021 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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
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