| CTRI Number |
CTRI/2024/06/069417 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to compare the effects of different combination of sedative drugs in patients undergoing surgery for head and neck cancer |
|
Scientific Title of Study
|
A Randomized Study to Compare Efficacy of Combination of Dexmedetomidine and Midazolam versus Fentanyl and Midazolam in Head and Neck Cancer patients for Awake Flexible Nasotracheal Intubation in Department of Anaesthesia SMS Medical College Jaipur |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushil Kumar Bhati |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Anesthesiology Sawai Mansingh Medical College, second floor Dhanvantri block,JLN Marg Jaipur Rajasthan
Department of Anesthesiology Sawai Mansingh Medical College, second floor Dhanvantri block,JLN Marg Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414779786 |
| Fax |
|
| Email |
drsushilbhati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakshi Sharma |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Anesthesiology Sawai Mansingh Medical College, second floor Dhanvantri block,JLN Marg Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9902235223 |
| Fax |
|
| Email |
sakshisharma060296@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushil Kumar Bhati |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Anesthesiology Sawai Mansingh Medical College, second floor Dhanvantri block,JLN Marg Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414779786 |
| Fax |
|
| Email |
drsushilbhati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Sawai Mansingh Medical College Jaipur, Rajasthan
Pin code-302004 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology Sawai Mansingh Medical College Jaipur Rajasthan |
| Address |
Department of Anesthesiology, Sawai Mansingh Medical College Jaipur, Rajasthan
Pin code-302004 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SMS Medical College and Hospital Jaipur |
Tonk road/ JLN marg, Jaipur 302004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sushil Kumar Bhati |
Sawai Mansingh Medical College Jaipur |
Department of Anaesthesiology, Dhanwantri block Sawai Mansingh Medical College,JLN Marg, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
9414779786
drsushilbhati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS,JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Awake nasotracheal intubation |
Awake nasotracheal intubation using flexible bronchoscope in which group 1 will be receiving Midazolam 0.03mg/kg and an infusion of Dexmedetomidine 1mcg/kg diluted in 50ml saline over 10 minute whereas group 2 will be receiving Midazolam 0.03mg/kg and an infusion of Fentanyl 2mcg/kg diluted in 50ml saline over 10 minute |
| Comparator Agent |
Dexmedetomidine and Midazolam versus Fentanyl and Midazolam |
To compare the efficacy of combination of Dexmedetomidine and Midazolam versus Fentanyl and Midazolam in head and neck cancer patients for awake flexible nasotracheal intubation in which group 1 will be receiving intravenous Midazolam 0.03mg/kg and an infusion of Dexmedetomidine 1mcg/kg diluted in 50ml saline over 10 minute whereas group 2 will be receiving intravenous Midazolam 0.03mg/kg and an infusion of Fentanyl 2mcg/kg diluted in 50ml saline over 10 minute |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing head and neck cancer surgeries requiring awake nasotracheal intubation with flexible bronchoscope, patient willing to participate in the study, adult patient aged between 30-70 years of either gender, patient belonging to ASA grade I,II,III. |
|
| ExclusionCriteria |
| Details |
Patients with history of obstructive sleep apnoea, nasal trauma, nasal surgery and bleeding diathesis, patient with history of allergy to the study drugs, non-cooperative or mentally retarded patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-Mean time required for intubation in minutes
2-Sedation score-Observers Assessment of Alertness score/Sedation Score (OAA/S)
3-ease of intubation score |
1-Baseline
2-10 minutes after the drug infusion
3-one minute post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean of Haemodynamic parameters (HR,SpO2, SBP, DBP, MAP), proportion of cases with complications, recall of procedure |
Just after surgery, 1 hour after surgery |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/07/2024 |
| 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 |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Awake nasotracheal intubation is recommended technique for securing airway in patients with anticipated difficult intubation while keeping the patient concious but sedated with intact respiratory drive to ensure better patient comfort and cooperation during the procedure.This study aims to compare the efficacy of combination of Dexmedetomidine and Midazolam versus Fentanyl and Midazolam in head and neck cancer patients for awake flexible nasotracheal intubation. For this a total of eighty four patients ( n=84) undergoing surgery for head and neck cancer fulfilling the inclusion criteria will be divided into two groups of 42 patients each Group A and B. Group A patients will be receiving Midazolam 0.03mg/kg and an infusion of Dexmedetomidine 1mcg/kg diluted in 50 ml saline over 10 minutes whereas group B will be receiving Midazolam 0.03mg/kg and an infusion of Fentanyl 2mcg/kg diluted in 50 ml saline over 10 minutes. Level of sedation will be assessed using modified Observers Assessment of Alertness Sedation Score (OAA/S) . After adequate Sedation intubation will be done using flexible bronchoscope and the position of endotracheal tube will be confirmed by end tidal capnography . Anaesthesia will be induced and maintained. After completion of the surgery all anaesthetic agents will be withdrawn , residual neuromuscular block will be reversed with injection Neostigmine 0.06mg/kg and injection Glycopyrrolate 0.001mg/kg . Patient will be extubated when fully awake having good motor power and obeying verbal commands following which the patient will be shifted to recovery room and monitored. 2 hours post extubation patient will be evaluated for recall of the procedure. |