| CTRI Number |
CTRI/2025/05/087140 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of intranasal dexmedetomidine and lignocaine spray on the laryngoscopy response during intubation. |
|
Scientific Title of Study
|
Comparison between intranasal dexmedetomidine and oropharyngeal lignocaine spray on attenuation of stress response during laryngoscopy for tracheal intubation in patients undergoing elective surgeries - A triple blinded 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 |
Raichel Kurian |
| Designation |
Post graduate registrar in department of Anaesthesiology |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesiology
Christian Medical College
Vellore
Tamil Nadu, India
Vellore TAMIL NADU 632004 India |
| Phone |
8547726721 |
| Fax |
|
| Email |
kurian.raichel@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.Sajan Philip George |
| Designation |
Professor in department of Anaesthesiology |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesiology
Christian Medical College
Vellore
Tamil Nadu India
Vellore TAMIL NADU 632004 India |
| Phone |
0416 2282105 |
| Fax |
|
| Email |
sajanpg@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Raichel Kurian |
| Designation |
Post graduate registrar in department of Anaesthesiology |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesiology
Christian Medical College
Vellore
Tamil Nadu, India
TAMIL NADU 632004 India |
| Phone |
8547726721 |
| Fax |
|
| Email |
kurian.raichel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid Research Fund , Institutional review board, Christian medical college Vellore district Tamil Nadu India pin 632004 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Fluid Research Fund |
| Address |
Office of Research Christian Medical College Vellore Tamil Nadu pin 632 002 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Raichel Kurian |
Christian Medical College Vellore |
Department of Anaesthesiology
Christian Medical College
Vellore
Tamil Nadu, India pin 632004 Vellore TAMIL NADU |
8547726721
kurian.raichel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institutional Review Board christian medical college vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
1 mcg per kg intranasal Dexmedetomidine using mucosal atomization device 30 minutes prior to induction of anaesthesia. 1microgram per kilogram dose of dexmedetomidine is given as a single dose 30 minutes prior to anaesthesia in the nose using a spraying device in the holding bay. Placebo with normal saline will be given for patients belonging to the lignocaine at this time with equivalent volume to dose of lignocaine which is 1.5miligram per kiligram |
| Comparator Agent |
Lignocaine |
1.5mg per kg of 10 percent lignocaine spray using mucosal atomizer device in the oropharynx just prior to induction of anaesthesia. A single dose of 10% lignocaine spray is used and 1.5 milligram per kg dose is given in the mouth ie oropharynx just before starting induction of anaesthesia in operation theatre using atomizing device . Patients will receive normal saline as placebo just prior to induction if the belong to the dexmedetomidine group with equivalent volume of the dose which is 1 microgram per kilogram. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults of age 18 and 60 years of ASA I and II undergoing elective surgery under general anaesthesia with oral endotracheal tube intubation |
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergy to either dexmedetomidine or lignocaine
ASA III and IV
Anticipated difficult airway
Severe upper respiratory tract infection
Known cardiac disease or liver disease
BMI greater than 30kg per m2
Pregnant women
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of intranasal dexmedetomidine and lignocaine spray on the laryngoscopy response in patients undergoing elective surgeries |
baseline , 2 minute, 5 minutes, 10 minutes post tracheal intubation. Heart rate and Blood pressure will be measured |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of sore throat in patients post endotracheal intubation |
more than 6 hours to less than 10 hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="204" Sample Size from India="204"
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 3 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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="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
|
Through this study we aim to compare the effect of preoperative
intranasal dexmedetomidine and lignocaine spray in attenuation of haemodynamic
responses to laryngoscopy for endotracheal intubation in patients undergoing
elective surgeries. Patients planned for elective surgeries who are willing to
participate and meets inclusion criteria will be enrolled for the study. An
informed consent will be obtained from patients preoperatively using an
information sheet. Participants of the study will be divided into two groups by
computer generated block randomization. Group A will receive a 1mcg per kg of
intranasal dexmedetomidine with atomizing device of company MAD
Nasal Intranasal Mucosal Atomization Device 30
minutes prior to induction in holding bay. Group B will receive 1.5mg per kg of 10 percent lignocaine spray prior to induction onto the oropharyngeal mucosa with
atomization device. Both groups will receive normal saline placebo at the
respective time. All patients will
have standard ASA monitoring with peripheral intravenous access. General
anaesthesia will be administered as per standard institutional protocols. Induction
will be done with propofol 1 to 2mg per kg, Fentanyl 1 to 2mcg per kg and titrated to
effect to maintain haemodynamics, Atracurium 0.5mg per kg. Anaesthesia will be maintained with a MAC
of 0.7 to 0.8 of isoflurane. Unanticipated difficult
airway, Intubation time, number of attempts, haemodynamic response to scopy as Heart rate and Blood Pressure at baseline, 2 ,5 and 10 min post tracheal
intubation to be noted. Any bradycardia, hypotension, tachycardia or
hypertension greater than 20 percent will be treated as per standard guidelines. Incidence of
sore throat post surgery will be documented.
|