| CTRI Number |
CTRI/2018/02/012197 [Registered on: 28/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
25/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial intended to study the effect of drug dexmedetomidine in preventing agitation in adults after surgery under general anaesthesia |
|
Scientific Title of Study
|
Dexmedetomidine infusion for prevention of emergence agitation after nasal surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratheek Reddy |
| Designation |
Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College and Hospitals
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
pratheek2223@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tejesh CA |
| Designation |
Associate Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College and Hospital
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejesh CA |
| Designation |
Associate Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College and Hospital
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Self funded by Investigators.
Department of Anaesthesiology,
MS Ramaiah Medical College,
Bangalore |
|
|
Primary Sponsor
|
| Name |
Tejesh CA |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College and Hospitals
Bangalore |
| Type of Sponsor |
Other [Investigator] |
|
|
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 |
| Tejesh CA |
MS Rahaiah Hospital |
Department of Anaesthesiology,
MS Ramaiah Hospital
New BEL road
Bangalore
Bangalore
KARNATAKA |
9886481848
drtejeshca@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee MS Ramaiah College and Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Health patients without any comorbidities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Dexmedetomidine as an intravenous infusion at the rate of 0.4mcg/kg/hr from the beginning of induction of general anaesthesia till extubation |
| Comparator Agent |
Placebo |
Volume matched saline infusion |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA)grade 1 and 2
Patients undergoing nasal surgery under general anaesthesia and requiring nasal packing after surgery |
|
| ExclusionCriteria |
| Details |
Known or suspected allergy to α2 adrenergic agonists.
Use of monoamine oxidase inhibitors, adrenergic blocking agents or clonidine.
Uncontrolled hypertension and Diabetes mellitus.
Heart block greater than first degree.
Cognitive impairment.
Chronic use of antipsychotic medications.
Kidney or liver disease.
Body Mass index ≥30kg/m²
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Emergence agitation assessed by Ricker sedation-agitation scale |
Emergence agitation assessed by Ricker sedation-agitation scale immediately after extubation of the patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time to verbal response and extubation
2.Introperative analgesic requirement
3.Duration of PACU stay |
1.After patient awakening from anaesthesia
2.At the end of Intraoperative period
3.At the time of discharge from recovery room |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2015 |
| Date of Study Completion (India) |
01/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomised, double blind, placebo controlled study to evaluate the efficacy of dexmedetomidine infusion at 0.4mcg/kg/hr from the beginning of induction till extubation for the prevention of emergence agitation in 100 ASA 1 & 2 adults aged 20-60yr undergoing nasal surgery under general anaesthesia. The primary outcome measure is the incidence of emergence agitation as assessed by Ricker sedation-agitation scale. |