| CTRI Number |
CTRI/2023/08/056218 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of a drug "dexmedetomidine" to prevent rise in blood pressure on general anesthesia |
|
Scientific Title of Study
|
Effect of intranasal dexmedetomidine on laryngoscopic pressor response and
intraoperative hemodynamic changes under general anesthesia: A double blinded
randomized placebo controlled trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun kumar A N |
| Designation |
Post graduate |
| Affiliation |
Pondicherry Institute of Medical Science |
| Address |
Department of Anesthesiology
Pondicherry Institute of Medical Science
Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9159281914 |
| Fax |
|
| Email |
arunkumar.arunbala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramya vel |
| Designation |
Professor |
| Affiliation |
Pondicherry institute of medical science |
| Address |
Department of Anesthesiology
Pondicherry Institute of Medical Science
Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487630425 |
| Fax |
|
| Email |
ramyavel1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun kumar A N |
| Designation |
Post graduate |
| Affiliation |
Pondicherry institute of medical science |
| Address |
Department of Anesthesiology
Pondicherry Institute of Medical Science
Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9159281914 |
| Fax |
|
| Email |
arunkumar.arunbala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology
Pondicherry Institute of Medical Science
Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry -605014 |
|
|
Primary Sponsor
|
| Name |
Pondicherry institute of medical science |
| Address |
Kalathumettupathai, Ganapathichettikulam, Village No.20,
Kalapet, Puducherry - 605 014 |
| 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 Arun kumar A N |
Department of Anesthesiology , Pondicherry Institute of Medical Sciences Hospital |
Pondicherry institute of medical sciences Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry - 605 014, INDIA.
Pondicherry
PONDICHERRY |
9159281914
arunkumar.arunbala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS Institute 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 |
| Intervention |
Intranasal dexmedetomidine |
Intranasal Dexmedetomidine will be given 0.1mcg/kg 30 mins before elective surgery |
| Comparator Agent |
Intranasal Normal saline |
Intranasal Normal saline will be given 30 mins before elective surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients belongs to 18 to 60 years of age
2. ASA I, ASA II (American Society of Anesthesiologist classification)
3. Patients undergoing endotracheal intubation in elective surgery under General
anesthesia
4. Duration of surgery lasting less than 3 hours |
|
| ExclusionCriteria |
| Details |
1. Patients undergoing Emergency surgeries
2. Anticipated difficult airway
3. Reduced cardiopulmonary reserve
4. Patient on beta blockers
5. Previous nasal surgery
6. Laparoscopic surgery
7. Laryngoscopic time exceeding 45 seconds
8. Laryngoscopy attempts more than 2 times |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate, Blood Pressure & Oxygen saturation
|
A baseline heart rate, blood pressure & oxygen saturation will be measured before
administration of the study drug, then at the time of administration and 10 mins once until the time
of scheduled intubation.
â–ª Post intubation vitals are measured at 1,2,3,4,5 & every 10 minutes until end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ramsay sedation score
visual analog score |
4 hrs in postoperative period |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/08/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Intranasal dexmedetomidine reduces laryngoscopic pressor response and maintain better perioperative hemodynamics when used as premedication.
1.Intranasal Dexmedetomidine is more effective in comparison with intranasal normal saline on attenuation of laryngoscopic response and maintaining hemodynamic stability during general anaesthesia. 2.Intranasal Dexmedetomidine has good analgesic effect and better recovery in post operative period |