CTRI Number |
CTRI/2021/10/037670 [Registered on: 29/10/2021] Trial Registered Prospectively |
Last Modified On: |
27/10/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
DEXMEDETOMIDINE TO REDUCE COUGH AND STRESS RESPONSE DURING EXTUBATION |
Scientific Title of Study
|
EFFECT OF A SINGLE DOSE OF DEXMEDETOMIDINE ON EXTUBATION STRESS RESPONSE DURING ANAESTHETIC EMERGENCE.
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Bhavish S |
Designation |
P G Student |
Affiliation |
Ramaiah Medical College |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,
M. S. RAMAIAH MEDICAL COLLEGE,
BENGALURU-560054, KARNATAKA.
Bangalore KARNATAKA 560054 India |
Phone |
7760463025 |
Fax |
|
Email |
bhavish.s.reddy@protonmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Leena H Parate |
Designation |
Associate professor |
Affiliation |
Ramaiah Medical College |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,
M. S. RAMAIAH MEDICAL COLLEGE,
BENGALURU-560054, KARNATAKA.
Bangalore KARNATAKA 560054 India |
Phone |
8217790902 |
Fax |
|
Email |
l_parate@protonmail.com |
|
Details of Contact Person Public Query
|
Name |
Bhavish S |
Designation |
P G Student |
Affiliation |
Ramaiah Medical College |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,
M. S. RAMAIAH MEDICAL COLLEGE,
BENGALURU-560054, KARNATAKA.
Bangalore KARNATAKA 560054 India |
Phone |
7760463025 |
Fax |
|
Email |
bhavish.s.reddy@protonmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Ramaiah Medical College |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,
M. S. RAMAIAH MEDICAL COLLEGE,
BENGALURU-560054, KARNATAKA.
|
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 |
Bhavish S |
Ramaiah Medical College Hospital |
Post Graduate,
Department Of
Anesthesia, M.S.
Ramaiah Medical
College, Bangalore
Bangalore
KARNATAKA
Bangalore KARNATAKA |
7760463025
bhavish.s.reddy@protonmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics committee M S Ramaiah Medical College |
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 |
Single bolus dose of dexmedetomidine 0.5mcg/kg i.v. diluted in 100ml of NS given over a duration of 10 minutes starting half hour prior to expected time of extubation extubation |
Comparator Agent |
Normal Saline |
100 ml of normal saline given over 10 minutes half hour prior to expected extubation |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
ASA 1 and 2 patients aged between 18 and 60 years scheduled to undergo elective surgery under general anaesthesia with endotracheal intubation. |
|
ExclusionCriteria |
Details |
1. Presence of an upper or lower respiratory tract infection.
2. Anticipated difficult airway.
3. Hepatic or renal dysfunction.
4. Poorly controlled hypertension.
5. Surgeries involving the upper airway.
|
|
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 assess and grade the severity of cough response at the time of extubation. |
During anesthetic emergence from surgery. Half hour after administering the test and control agents on the day of intervention only. no long term follow up planned |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study: a) Hemodynamic response namely heart rate, systolic blood pressures, diastolic blood pressures and mean arterial pressures at the time of extubation. b) Adverse events i.e. desaturation (spo292%), breath holding spells (apnoea15 seconds), laryngospasm, postoperative nausea and vomiting (PONV) at the time of extubation. c) Post-operative sedation. |
T0- basal parameters before anaesthetic induction; T1- before extubation; T2- after extubation; T3- 5 minutes after extubation. outcome is assessed on day of intervention only. no long term follow up is planned |
|
Target Sample Size
|
Total Sample Size="220" Sample Size from India="220"
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
|
N/A |
Date of First Enrollment (India)
|
31/10/2021 |
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="2" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Not published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhavish.s.reddy@protonmail.com].
- For how long will this data be available start date provided 01-10-2021 and end date provided 01-01-2023?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
|
Endotracheal intubation is a
commonly used mode of securing and isolating the airway in patients receiving
general anaesthesia. This is well tolerated when the patient is under adequate
anaesthetic depth. However during emergence from general anaesthesia, an
extubation stress response involving cough and adverse hemodynamic changes like
tachycardia and hypertension has been identified and studied by various
authors. (1-5) It is a significant and alarming event to the patient
undergoing extubation and may cause various distressing complications like
surgical site re-bleeding, laryngospasm, hypertension, myocardial ischemia,
oxygen desaturation, and violent behavior leading to injury to the patient,
healthcare personnel and support staff. (1,2) It is desirable to
avoid these unfavourable changes in patients during the time of extubation
after surgery.
Many pharmacologic agents like lignocaine, opioids, calcium channel
blockers, esmolol, magnesium sulphate, propofol, etc. have been shown to
attenuate these responses. (2,3,6) Dexmedetomidine is one such drug.
It is an alpha-2 adrenergic receptor agonist. It finds use in the intensive
care setting for sedation of intubated patients and also in non-intubated
patients for sedation in the perioperative period without depressing the
respiratory drive. (2) It has been used in various doses ranging
from 0.5mcg/kg to 1mcg/kg; with all doses providing adequate sedation but higher
doses increasing the risk of adverse hemodynamic outcomes. (4) It has also been found that a single
bolus administration of dexmedetomidine is associated with a lower incidence of
emergence delirium and pain scores as compared to a continuous infusion. (5)
Thus, a single bolus dose of dexmedetomidine is an easy and
straightforward technique to reduce extubation stress response.
We intend to study the effect of a
single bolus dose of dexmedetomidine on the prevention of cough response at the
time of extubation. We also intend to study hemodynamic changes, adverse events
and post-operative sedation over the course of emergence from general
anaesthesia. |