| CTRI Number |
CTRI/2024/02/063320 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of a drug named Dexmedetomidine which is administered through nose before insertion of tube through windpipe for management of anaesthesia |
|
Scientific Title of Study
|
The effect of Intranasal Dexmedetomidine on Hemodynamic responses during Double Lumen Tube insertion- A 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 |
Roys Prathima G |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology, Christian Medical College, Vellore, Tamilnadu, India
Vellore TAMIL NADU 632004 India |
| Phone |
8660889336 |
| Fax |
|
| Email |
roysprathima34@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Balaji Kuppuswamy |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology, Christian Medical College, Vellore, Tamilnadu, India
Vellore TAMIL NADU 632004 India |
| Phone |
7406777127 |
| Fax |
|
| Email |
balooswamy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Balaji Kuppuswamy |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology, Christian Medical College, Vellore, Tamilnadu, India
TAMIL NADU 632004 India |
| Phone |
7406777127 |
| Fax |
|
| Email |
balooswamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid Research Grant, Christian Medical College, Vellore- 632004 Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Roys Prathima G |
| Address |
Dr Roys Prathima G, Department of Anaesthesiology, Christian Medical College, Vellore- 632004, Tamilnadu, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Roys Prathima G |
Christian Medical College |
Department of Anaesthesiology, Christian Medical College Vellore TAMIL NADU |
8660889336
roysprathima34@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insstitutional Review Board and Ethics Committee of CMC Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal Dexmedetomidine group |
Intranasal Dexmedetomidine-1mcg/kg administered 45 minutes prior to induction and Hemodynamic responses To Laryngoscopy and Endobronchial intubation with DLT is observed |
| Comparator Agent |
Placebo group |
Intranasal Normal saline- 2ml administered 45 minutes prior to induction and Hemodynamic Responses to Laryngoscopy and Endobronchial intubation with DLT is observed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective lung surgery including pulmonary lobectomy, pneumonectomy, metastasectomy, decortication, etc who require Left sided DLT placement
ASA Physical status I to III
|
|
| ExclusionCriteria |
| Details |
1. Patients with difficult airway
2. Surgeries requiring Right sided Double Lumen Tube insertion
3. Uncontrolled hypertensives
4. Heart disease with ejection fraction less than 40%
5. Body mass index more than 35 kg/ m2
6. History suggestive of sensitivity to drugs used during the study
7. Patients with bradycardia (heart rate < 50 beats per minute) or any heart block
8. Nasal pathology
9. History of reactive airway disease
10. Hepatic or Renal impairment
11. Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Hemodynamic responses between Dexmedetomidine and Placebo given in addition to drugs used in our current standard of care during laryngoscopy and DLT insertion |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the requirement of additional anaesthetic drugs ( fentanyl, propofol) in order to maintain the hemodynamics within 20% of baseline values during Laryngoscopy and DLT insertion
2. To assess the incidence of hypotension and bradycardia during drug administration and during laryngoscopy and DLT insertion
3. To assess the intraoperative requirement of rescue medication ( phenylephrine, ephedrine) to treat the hypotension and bradycardia |
1 hour |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
07/03/2024 |
| 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="7" 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
|
Tracheal intubation and laryngoscopy may cause sympathetic stimulation, which can cause tachycardia and hypertension. To abolish the pressor response to laryngoscopy and endotracheal intubation, many medication combinations have been tried with varying degrees of efficacy.
The purpose of this study is to evaluate the effect of Intranasal Dexmedetomidine on hemodynamic responses to laryngoscopy and endobronchial intubation with a double lumen tube. Patients coming for elective lung surgery meeting the required inclusion criteria will be enrolled for this study. Information about the study will be conveyed and consent obtained in the preoperative period.
Patients will be divided into two groups by computer-generated block randomization: Group A will receive Intranasal dexmedetomidine (1mcg/kg) diluted in 2 ml syringe and Group B will receive placebo (0.9 % saline) in 2 ml syringe in equal volume into both nostrils.
Patients in pre induction room, after connecting to standard ASA monitors – ECG, Pulse Oximetry, Blood Pressure, study drug will be administered belonging to either Group A (Dexmedetomidine) or Group B (Placebo). 45 minutes after administration of the study drug, patients will be wheeled into Operating Theatre. After connecting standard ASA monitors, all patients will be induced with IV propofol upto 2mg/kg, fentanyl 1 mcg/kg, lignocaine 1.5mg/kg and vecuronium 0.1 mg/kg, in accordance with the current standard of care given in our hospital. Anaesthesia will be maintained with sevoflurane to get a MAC of 1 until tracheal intubation. After 3 minutes of mask ventilation, laryngoscopy and DLT insertion will be performed by an anaesthesiologist at the level of final year MD registrar or above. If the first attempt by the registrar is unsuccessful, subsequent attempts will be done by the senior anaesthesiologist posted on the list.
Episodes of hypotension will be treated with a bolus of Ephedrine hydrochloride 3-6mg or Phenylephrine 25-50 mcg. Bradycardia will be treated with 0.3-0.6 mg atropine bolus. Any hypertension or tachycardia will be treated with additional doses of propofol and/or fentanyl. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR), will be recorded at baseline and regular intervals. All incidences of hypotension and bradycardia will be documented and the number of doses of rescue medication administered will be noted. The total laryngoscopy and DLT insertion time, total fiberoptic bronchoscopy time and total isolation time will be noted.
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