FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/067063 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the beneficial effects of dexmedetomidine drug by adding to lignocaine nebulization in patients undergoing general anesthesia for better outcome. 
Scientific Title of Study   Comparison of Lignocaine Nebulization versus Lignocaine with Dexmedetomidine Nebulization for Awake Fiberoptic Intubation: A Double Blind Randomized Controlled Trial 
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 T G KHAAR MUGILAN  
Designation  POST GRADUATE  
Affiliation  Sri Manakula Vinayagar Medical College and Hospital  
Address  Department of Anesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Madagadipet, Kalitheerthalkuppam, Puducherry 605107

Pondicherry
PONDICHERRY
605009
India 
Phone  8903307624  
Fax    
Email  tgkhaarmugilan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr C PRASATH 
Designation  PROFESSOR  
Affiliation  Sri Manakula Vinayagar Medical College and Hospital  
Address  Department of Anesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Madagadipet, Kalitheerthalkuppam, Puducherry 605107

Pondicherry
PONDICHERRY
605107
India 
Phone  9787740890  
Fax    
Email  drpathin2@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr C PRASATH 
Designation  PROFESSOR  
Affiliation  Sri Manakula Vinayagar Medical College and Hospital  
Address  Department of Anesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Madagadipet, Kalitheerthalkuppam, Puducherry 605107

Pondicherry
PONDICHERRY
605107
India 
Phone  9787740890  
Fax    
Email  drpathin2@gmail.com  
 
Source of Monetary or Material Support  
Sri Manakula Vinayagar Medical College and Hospital, Madagadipet, Kalitheerthalkuppam, Puducherry India 605107  
 
Primary Sponsor  
Name  Dr T G KHAAR MUGILAN  
Address  Department of Anesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Madagadipet, Kalitheerthalkuppam, Puducherry 605107 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr T G KHAAR MUGILAN   Sri Manakula Vinayagar Medical College and Hospital   Room no : 106 First floor, OT Complex Department of Anesthesiology
Pondicherry
PONDICHERRY 
8903307624

tgkhaarmugilan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMVMCH - Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: V299||Motorcycle rider (driver) (passenger) injured in unspecified traffic accident,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nebulization Lignocaine   4%Lignocaine 5ml diluted with 2ml normal saline given via nebulization only once for 20 minutes  
Intervention  Nebulization Lignocaine + Dexmedetomidine   4%Lignocaine 5ml + Dexmedetomidine 1.5mcg/kg diluted with normal saline upto 7 ml given via nebulization only once for 20minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients scheduled to undergo elective surgeries under general anesthesia.
2.Patients of ASA physical status I&II.
3.Patients of either sex.
4.Age 18 to 60 years.
5.Body Mass Index 18 to 35 kg/m2. 
 
ExclusionCriteria 
Details  1.Patients with difficult airway.
2.Pregnant/Lactating Women.
3.Severe mental illness, or Cognitive dysfunction (unable to communicate or cooperate)
4.Patients with thrombocytopenia or coagulopathy.
5.Patients with nasal polyps, history of
previous nasal surgery/nasal trauma.
6.Patients allergic to the drugs involved in the
study.
7.Patients refusal for participation in the study. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Estimate and compare mean intubation time in Lignocaine Nebulization and Lignocaine with Dexmedetomidine Nebulization for Awake Fiberoptic Intubation  Seconds (during intubation) 
 
Secondary Outcome  
Outcome  TimePoints 
1.To Estimate and compare hemodynamic changes and level of sedation in both groups
2.To Assess and compare intubation condition, vocal cord position, cough severity, patient tolerance and postoperative patient satisfaction in both groups 
1,2,3,5,10,20Minutes  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   20/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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 Fiberoptic Intubation (AFOI) is a newer, emerging and effective technique for establishing airway access in patients having both anticipated and unanticipated difficult airway with respect to compromised airway, inadequate mouth opening as in temporomandibular joint disease, mandibular-maxillary fixation, severe facial trauma and burns, oropharyngeal mass, limited surgical field, when neck extension is to be avoided, vertebral artery insufficiency etc. Preparing the patient before AFOI is the crucial step for adequate airway anesthesia and for ease intubation. Topical application of local anaesthesia by nebulization technique is one of the promising techniques used to anaesthetize the airway. The purpose of the study is to evaluate the effect of adding dexmedetomidine to lignocaine for optimum airway anesthesia in awake fibre optic intubation and to evaluate the beneficial effects of dexmedetomidine like anxiolytic, hypnotic, sedative.Since the patient will be awake during intubation, we assume that adding dexmedetomidine will be beneficial and provide better patient tolerability during the procedure. Enrolled patients will be allotted to one of the groups (AorB). Based on the randomization sequence, the patients will be allocated into two groups, Group A and Group B.Group A patients will receive 4%Lignocaine 5ml nebulization and the patient belonging to Group B will receive Dexmedetomidine 1.5mcg/kg + 4%Lignocaine 5ml nebulization. According to the sequence,the drugs(Lignocaine&Dexmedetomidine-Lignocaine) will be handed over to the anesthesiologist and advised to give respective drug nebulization as per code received by patient. 
Preanesthetic evaluation will be conducted with thorough airway examination including modified Mallampati grading, thyromental distance and upper lip bite test. The procedure of awake fiberoptic intubation will be explained to all patients and informed consent will be obtained. After shifting the patient to preoperative room, an intravenous line will be secured with 18 G IV cannula and baseline parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure(DBP), mean arterial blood pressure(MAP) and oxygen saturation (SpO2 ) will be measured. Inj. Glycopyrrolate 0.2mg IV will be given 30 minutes before surgery and two drops of Xylometazoline 0.1% will be instilled in both nostrils. Patients will be nebulized for 20 mins before nasal intubation along with oxygenation with face mask @ 4 L/min flow. All patients will receive Inj. Midazolam 1 mg intravenously at 15th minute of nebulization. To ensure double blindness, patients will be nebulized by an anesthesiologist who is not involved in further study. Another anesthesiologist will perform the procedure and record the data. Continuous monitoring of vitals will be done at baseline, at 5, 10, 15, 20 min during nebulization, just before procedure, at 1, 2, 3, 4, 5 min during procedure and post procedure at 1, 3, 5, 10 and 15 mins. Sedation level will be assessed at baseline, at 5, 10, 15, 20 min during nebulization and just before procedure with Ramsay Sedation score.Adequacy of local anaesthesia will be confirmed by heaviness of the tongue and dryness of posterior pharynx of patients. Patient will be pre-oxygenated with 100% oxygen at 8L/min for 3-5 minutes. After application of lignocaine gel, Awake fiberoptic intubation will be performed using flexible videoendoscope , 5.0 mm outer diameter preloaded with 7.0 mm ID ET tube for female patient and 7.5 mm ID ET tube for male patient respectively. During videoendoscopy, 2 ml lignocaine 4% will be administered by spray as you go technique. Patient tolerance during and after AFOI will be assessed by grading system. ET tube position will be confirmed by auscultation and capnography. The amount of total lignocaine required in each patient will be also noted. 
Intubation time was defined as the time from passing the videoendoscope tip through the nostril to the first reading obtained by the capnograph after endotracheal intubation. The mean intubation time will be assessed. A Grading system will be used for assessing intubating conditions, vocal cord positions and patient tolerance during and after intubation. General anaesthesia will be administered with Inj. Fentanyl 2-3 mcg/kg IV, Inj. Propofol 2-3 mg/kg IV and Inj.Vecuronium 0.1 mg/kg IV or Inj. Atracurium 0.5 mg/kg IV. Anaesthesia will be maintained with Oxygen and Nitrous Oxide (50:50), Sevoflurane up to 2% v/v and intermittent dose of Vecuronium 0.02 mg/kg IV for muscle relaxation. Reversal will be given with Inj.Neostigmine 2.5 mg and Inj. Glycopyrrolate 0.5 mg IV at the end of the surgery. Postoperatively, after 24 hours patient satisfaction will be assessed using the grading system.


 
Close