| CTRI Number |
CTRI/2023/10/058557 [Registered on: 12/10/2023] Trial Registered Prospectively |
| Last Modified On: |
15/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Inhalational versus intravenously administered dexmedetomidine for blunting hemodynamic responses to laryngoscopy and intubation: a randomized double blind comparative study |
|
Scientific Title of Study
|
Clinical comparison of nebulised versus intravenously administered dexmedetomidine for obtunding hemodynainic responses to laryngoscopy and intubation: a randomized double blind comparative study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajkumar Saraswat |
| Designation |
RESIDENT DOCTOR, DEPARTMENT OF ANAESTHESIA |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
| Address |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL, SITAPURA, JAIPUR
Jaipur
RAJASTHAN
302022
India |
| Phone |
7069977268 |
| Fax |
|
| Email |
raj.saraswat46@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AKSHITA SINGLA |
| Designation |
Assistant Professor, Department of Anaesthesia |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
| Address |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL, SITAPURA, JAIPUR
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL, SITAPURA, JAIPUR
Jaipur
RAJASTHAN
302022
India |
| Phone |
8558084975 |
| Fax |
|
| Email |
dr.akshita.singla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajkumar Saraswat |
| Designation |
RESIDENT DOCTOR, DEPARTMENT OF ANAESTHESIA |
| Affiliation |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
| Address |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL, SITAPURA, JAIPUR
Jaipur
RAJASTHAN
302022
India |
| Phone |
7069977268 |
| Fax |
|
| Email |
raj.saraswat46@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL, JAIPUR |
|
|
Primary Sponsor
|
| Name |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
| Address |
SITAPURA, JAIPUR |
| 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 |
| Dr Rajkumar Kishorkumar Saraswat |
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIA, OT COMPLEX.
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
7069977268
raj.saraswat46@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Institutional Ethics Committee Mahatma Gandhi Medical College and Hospital |
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 |
| Comparator Agent |
Intravenous Dexmedetomidine |
1 mcg/kg dexmedetomidine in 100ml normal saline intravenously 30 mins prior to induction of general anaesthesia. |
| Intervention |
Nebulised versus Intravenously administered dexmedetomidine |
1 mcg/kg dexmedetomidine diluted to total volume of 5ml with normal saline 30 mins prior to induction of general anaesthesia versus 1 mcg/kg dexmedetomidine in 100ml normal saline intravenously 30 mins prior to induction of general anaesthesia. |
| Comparator Agent |
Nebulized Dexmedetomidine |
1 mcg/kg dexmedetomidine diluted to total volume of 5ml with normal saline 30 mins prior to induction of general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Elective surgeries under general anaesthesia
Patients of either sex having age 18-55years
Body weight 50 to 70 kgs
American society of anaesthesiologists (ASA) physical status I – II
Patient’s written and informed consent |
|
| ExclusionCriteria |
| Details |
Patient refusal for the anaesthetic technique.
Patients having mouth opening < 3 Cms or predicted difficult airway.
Patient with severe renal, hepatic, respiratory and cardiac disease.
Any bleeding disorder or patient on anticoagulants
History of allergy to study drug
Patient belonging to ASA CLASS III, IV & V
Patients on any sedatives, antipsychotics, antidepressants, anxiolytics or anticonvulsants and betablockers.
Patient with any nasal pathology like nasal ulcer, nasal polyp, nasal septum deviation.
Patients with difficult airway like cervical spine instability, facial fractures, partially obstructing laryngeal lesions (e.g., papilloma), craniofacial abnormalities, and temporo mandibular joint ankylosis.
Patient coming for emergency surgery
Pregnant patients
H/O Covid infection during last 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study will be to compare intravenous dexmedetomidine with nebulised dexmedetomidine as premedication for attenuation of laryngoscopic and intubation response. |
Vitals will be recorded on starting the study drugs and after every 5 minutes interval till the endotracheal tube is inserted. Also, vitals will be recorded immediately after intubation, 1,3 and 5 minutes after intubation thereafter every 5 minutes up to 30 minutes after insertion of endotracheal tube than at extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcome of the study will be to study and compare the sedation score and
to study and compare the complications encountered with the two routes |
Sedation score will be calculated at 20 mins after giving drug and any complications will be noted during whole procedure. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/10/2023 |
| Date of Study Completion (India) |
14/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published on Cureus.
Published: February 23, 2024
DOI: 10.7759/cureus.54768 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dexmedetomidine is well known to attenuate the laryngoscopic response when administered intravenous, however its adverse effects have limited its use. Various studies have been done to study effectiveness of intranasal dexmedetomidine. however there has been no mention of the comparison of side effects between the two routes. Studies with nebulization with dexmedetomidine are limited. The proposed study intends to use a different route of administration(nebulization) to determine its efficacy in attenuation of laryngoscopic response with lesser incidence of adverse effects. A human clinical study only can provide insight in to such issues. |