| CTRI Number |
CTRI/2023/05/052183 [Registered on: 01/05/2023] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To know how dexmedetomidine (used as sedative, antihypertensive) used via 2 different routes i.e., inhalation or through intravenous infusion helps in reducing blood pressure and heart rate while inserting a tube in trachea (windpipe) for providing general anaesthesia |
|
Scientific Title of Study
|
A comparative evaluation of nebulised and intravenous dexmedetomidine on attenuation of haemodynamic response to laryngoscopy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reshma B M |
| Designation |
Associate professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology,1st floor, OT complex, Dr B R Ambedkar medical hospital, Kadugondanahalli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reshma B M |
| Designation |
Associate professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology,1st floor, OT complex, Dr B R Ambedkar medical hospital, Kadugondanahalli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reshma B M |
| Designation |
Associate professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology,1st floor, OT complex, Dr B R Ambedkar medical hospital, Kadugondanahalli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Reshma B M |
| Address |
Department of Anaesthesiology, 1st floor, OT complex, Dr B R Ambedkar medical hospital, Bengaluru -560045 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| M Salim Iqbal |
Department of Anaesthesiology, 1st floor, OT complex, Dr B R Ambedkar medical hospital, Bengaluru -560045 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Reshma B M |
Dr B R Ambedkar medical hospital |
1st floor, OT complex, department of Anesthesiology, Kadugondanahalli, Bengaluru
Bangalore
KARNATAKA |
8892019120
lucky3276@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee |
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 |
Dexmedetomidine |
Intravenous dexmedetomidine 1mcg/kg will be given 30 minutes before induction. |
| Intervention |
Dexmedetomidine |
Nebulised dexmedetomidine 1mcg/kg will be given 30 minutes before induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective surgeries under general anaesthesia
2. Patients belonging to American Society of Anaesthesiologists Physical Status (ASA-PS) 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patient allergic to study drug
3. BMI > 30 kg/m2.
4. Patients with difficulty airway, unanticipated difficult laryngoscopy and intubation
( lasting > 15 seconds or more than 2 attempts at intubation)
5. Pregnancy and lactation.
6. Patient on opioids, sedatives, or beta blockers. |
|
|
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. To assess the effect of nebulized and intravenous dexmedetomidine on mean
arterial pressure response following laryngoscopy. |
1. Following laryngoscopy at baseline, every minute for 5 minutes and at 10th minute. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine the dose sparing effect of induction dose of propofol.
2. To assess the sedation scores preoperatively, using Modified Ramsay sedation score.
3.To assess for side effects if any. |
1. After induction of anaesthesia.
2. Every 5 minutes after drug administration for 30 minutes.
3. From start of drug administration till end of surgery. (every 5 minutes) |
|
|
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)
|
16/05/2023 |
| Date of Study Completion (India) |
24/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/10/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dexmedetomidine is a highly selective alpha-2 adrenergic agonist. It is a short-acting sedative, hypnotic, anxiolytic, and analgesic with sympatholytic properties. Its pleiotropic effects have increasingly led to a reduction in anesthetic and analgesic requirements, hence used in the perioperative period. It can be used in various routes like intravenous, intramuscular, nasal, oral, subcutaneous, etc. In our study, we aim to study the efficacy of inhaled dexmedetomidine to intravenous dexmedetomidine in the suppression of intubation response. We hypothesize that dexmedetomidine, when given through the inhalation route, attenuates the intubation response with a better hemodynamic profile with minimal side effects in comparison with intravenous dexmedetomidine. |