| CTRI Number |
CTRI/2018/02/012009 [Registered on: 20/02/2018] Trial Registered Prospectively |
| Last Modified On: |
29/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of dexmedetomidine with different induction agents on smooth initiation of anesthesia and better cardiovascular stability during intubation. |
|
Scientific Title of Study
|
Effect of Dexmedetomidine on induction and hemodynamic response to laryngoscopy and intubation with Propofol and Sevoflurane |
| Trial Acronym |
EDIHLIPS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navya C N |
| Designation |
Assistant professor |
| Affiliation |
Sri MuthuKumaran Medical College, Hospital And Research Institute, |
| Address |
Dr Navya C N
Assistant Professor
Department of Anaesthesiology
SMMCHRI
Chennai – 600069
Sri MuthuKumaran Medical College, Hospital And Research Institute,
chikkarayapuram,
near Mangadu
chennai 600069
Chennai
TAMIL NADU
600069
India |
| Phone |
9791793965 |
| Fax |
|
| Email |
drcn.navya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navya C N |
| Designation |
Assistant professor |
| Affiliation |
Sri MuthuKumaran Medical College, Hospital And Research Institute, |
| Address |
Dr Navya C N
Assistant Professor
Department of Anaesthesiology
SMMCHRI
Chennai – 600069
Sri MuthuKumaran Medical College, Hospital And Research Institute,
chikkarayapuram,
near Mangadu
chennai 600069
TAMIL NADU
600069
India |
| Phone |
9791793965 |
| Fax |
|
| Email |
drcn.navya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navya C N |
| Designation |
Assistant professor |
| Affiliation |
Sri MuthuKumaran Medical College, Hospital And Research Institute, |
| Address |
Dr Navya C N
Assistant Professor
Department of Anaesthesiology
SMMCHRI
Chennai – 600069
Sri MuthuKumaran Medical College, Hospital And Research Institute,
chikkarayapuram,
near Mangadu
chennai 600069
TAMIL NADU
600069
India |
| Phone |
9791793965 |
| Fax |
|
| Email |
drcn.navya@gmail.com |
|
|
Source of Monetary or Material Support
|
| monitory support- self
material support: srimuthukumaran medical college hospital and research institute |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| 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 Navya C N |
Sri MuthuKumaran Medical College, Hospital And Research Institute |
department of Anesthesiology
Operation Theatre complex
Chennai
TAMIL NADU |
9791793965
drcn.navya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri MuthuKumaran Medical College, Hospital And Research Institute,instituitinal ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I &II patients posted for elective surgeries under general anesthesia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
inj dexmedetomidien 1mcg/kg infusion and inj propofol |
On arrival in the operating room, the patients baseline heart rate, blood pressure and oxygen saturation (SpO 2) will be recorded after 5 min settling in the operative room. A 20G intravenous cannula will be inserted for drug and continuous fluid administration.
after premedication and
Prior induction: Dexmedetomidine (1.0µg / kg) over 10 min in both the groups.
GroupD P: patients were induced with titrating dose of 1% Propofol (10 mg/ml) injected manually at the rate of 1.5 ml every 5 seconds.
All patients will be relaxed with IV Vecuronium 0.1mg/kg.
Patient will be ventilated for 3min. Laryngoscopy using Macintosh laryngoscope and appropriate sized cuffed endotracheal intubation will be done.
|
| Intervention |
inj dexmedetomidine and sevoflurane induction |
10 ins before induction : inj dexmedetomidine 1mcg/kg iv infusion over 10 mins
Group DS: patients will be induced with (8%) Sevoflurane at tidal breathing using circle system. |
| Comparator Agent |
NOT APPLICABLE |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA I or II (no or minimal co-morbid disease)
2.Patients scheduled for elective surgeries
|
|
| ExclusionCriteria |
| Details |
1.History of allergy or contraindications study drug
2.Concomitant use of medications which may exaggerate the heart rate response of Dexmedetomidine including digoxin or β-adrenergic antagonists.
3.Predicted difficulty in intubation,
4.pregnant patients
5.nursing women
6.morbid obesity
7.Coronary artery disease
8.ischemic heart disease
9.heart blocks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective:
1. To compare the Mean Arterial Pressure and Heart Rate response to induction with Propofol and Sevoflurane after dexmedetomidine 1ïg/kg IV infusion.
2. To compare effectiveness of Dexmedetomidine 1ïg/kg with propofol and Dexmedetomidine 1ïg/kg with sevoflurane in attenuating cardiovascular response during laryngoscopy and intubation |
1. 5min after settling in OT
2. 2 min after administration of drug,
3.1min after induction and
4.at 1, 3, 5 and 10 min after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary objective: To compare time of induction and smoothness of induction |
The time of start of injection of propofol or mask placement with sevoflurane 8% was considered as ‘starting point of induction’. The patients were asked every 5 seconds, to open the eyes and loss of response to this command was defined as loss of verbal contact. Eyelash reflex will be then checked for additional confirmation of loss of consciousness which is defined as ‘induction end point’. The time taken for anesthetic induction will be recorded for both groups |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There are many studies on dexmedetomidine for
attenuation of stress response during laryngoscopy and intubation, but none of
the studies evaluate the effect of dexmedetomidine with different induction
agents. This study aims to evaluate the effect of dexmedetomidine on induction
with respect to hemodynamic response,dose required and smoothness of induction also to
evaluate the combined effect of dexmedetomidine with propofol and sevoflurane
on cardiovascular response to laryngoscopy and intubation. |