| CTRI Number |
CTRI/2021/11/038005 [Registered on: 12/11/2021] Trial Registered Prospectively |
| Last Modified On: |
11/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of intravenous and inhalational Dexmedetomidine in reducing response in terms of heart rate and blood pressure after laryngoscopy |
|
Scientific Title of Study
|
Comparison of Intravenous v/s Inhalational Dexmedetomidine on Laryngoscopic Response: A Prospective, Randomized, Double-blinded study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivanya Singh |
| Designation |
Junior Resident- Academic |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department Of Anaesthesiology, Level 6 -Medical College Wing, AIIMS Rishikesh Campus, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Dehradun District, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9810291836 |
| Fax |
|
| Email |
shivanyasingh111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Gupta |
| Designation |
Associate Professor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department Of Anaesthesiology, LEVEL 6 -Medical College Wing, AIIMS Rishikesh Campus, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Dehradun DISTRICT,UTTARAKHAND STATE
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Gupta |
| Designation |
Associate Professor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department Of Anaesthesiology,Level 6 -Medical College Wing, AIIMS Rishikesh Campus, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Dehradun District, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9811894899 |
| Fax |
|
| Email |
drpriyankagupta84@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
veerbhadra road, Rishikesh, uttarakhand |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priyanka Gupta |
Department of anesthesia, main OT complex level 6, AIIMS Rishikesh |
Departement ofanesthesia, Level-6 medical college
AIIMS
Dehradun
UTTARANCHAL |
09811894899
drpriyankagupta84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS RISHIKESH |
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 |
inhalational and intravenous dexmedetomidine |
one group will receive nebulization of dexmedetomidine preoperatively another group will receive intravenous infusion of dexmedetomidine preoperatively |
| Comparator Agent |
Intravenous Dexmedetomidine |
one group of patients will receive inhalational dexmedetomidine preoperatively, another group of patients will receive intravenous infusion of dexmedetomidne preoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II Patients undergoing elective surgery under general anaesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1.Anticipated Difficult laryngoscopy and intubation or more than one attempt for intubation taken.
2.Patient having cardiovascular dysfunction.
3.Pre-existing hepatic or renal impairment.
4.Pregnant patients.
5.Patient refusal for consent.
6.Allergic to Study Drug.
7.Uncontrolled Hypertensive
8.Patients with raised intracranial pressure.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Mean Arterial Pressure and Heart rate changes following laryngoscopy between the study groups. |
at laryngoscopy, just after intubation, 1, 5, 10 min following intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the propofol consumption during induction among the studied groups |
dose of propofol will be calculated after completion of laryngoscopy and intubation |
To compare preinduction hemodynamics and sedation following
administration of Dexmedetomidine. |
15 minutes following administartion of intravenous or inhalational dexmedetomidine in preoperative area |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
15/11/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, randomized, double-blinded, study to compare effectiveness of preoperative Inhalational Dexmedetomidine with Intravenous Dexmedetomidine in reducing the hemodynamic response to laryngoscopy among patients undergoing endotracheal intubation for elective surgery under general anaesthesia. the primary outcome is to compare the Mean Arterial Pressure and Heart Rate changes following laryngoscopy between the study groups at specific time intervals. Secondary outcome is to compare preinduction hemodynamics and sedation following administration of Dexmedetomidine and to compare the propofol consumption during induction among the studied groups. ASA-I/II, aged 18-60 patients undergoing elective surgery requiring endotracheal intubation will be included. Total included patient are 130, 65 patients in each group.
|