| CTRI Number |
CTRI/2017/03/008044 [Registered on: 08/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/03/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study will compare which drug is better for prevention of agitation occurring after awakening from anaesthesia given for nasal surgeries |
|
Scientific Title of Study
|
Comparison between dexmedetomidine and midazolam for emergence agitation after nasal surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranjali Kurhekar |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Dept of Anaesthesiology,
Shri Sathya Sai Medical College and Research Institute,
Tiruporur Guduvanchery Main Road, Ammapettai, Kancheepuram Dist.
Dept of Anaesthesiology,
Shri Sathya Sai Medical College and Research Institute,
Tiruporur Guduvanchery Main Road, Ammapettai, Kancheepuram Dist.
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
04427440700 |
| Fax |
04427440138 |
| Email |
pranjalikurhekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranjali Kurhekar |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Dept of Anaesthesiology,
Shri Sathya Sai Medical College and Research Institute,
Tiruporur Guduvanchery Main Road, Ammapettai, Kancheepuram Dist.
Dept of Anaesthesiology,
Shri Sathya Sai Medical College and Research Institute,
Tiruporur Guduvanchery Main Road, Ammapettai, Kancheepuram Dist.
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
04427440700 |
| Fax |
04427440138 |
| Email |
pranjalikurhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranjali Kurhekar |
| Designation |
Associate Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Dept of Anaesthesiology,
Shri Sathya Sai Medical College and Research Institute,
Tiruporur Guduvanchery Main Road, Ammapettai, Kancheepuram Dist.
Dept of Anaesthesiology,
Shri Sathya Sai Medical College and Research Institute,
Tiruporur Guduvanchery Main Road, Ammapettai, Kancheepuram Dist.
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
04427440700 |
| Fax |
04427440138 |
| Email |
pranjalikurhekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute.
Tiruporur-Guduvanchery main road, Ammapettai, Kancheepuram district
Tamilnadu - 603108 |
|
|
Primary Sponsor
|
| Name |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Tiruporur Guduvanchery Main Road, Ammapettai
Kancheepram Dist, Tamilnadu 603108 |
| 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 Pranjali Kurhekar |
Shri Sathya Sai Medical College and Research Institute, Ammapettai |
Second floor, main OT complex,Department of Anaesthesiology, hospital block.
Kancheepuram
TAMIL NADU |
9486414942
04427440138
pranjalikurhekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA physical status I and II posted for nasal surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I - Inj dexmedetomidine |
Group I would receive Inj dexmedetomidine as 0.5 mcg/kg by intravenous route over 15 minutes and then 0.1mcg/kg/hr as infusion |
| Comparator Agent |
Group II - Inj Midazolam |
Group II receive Inj midazolam as 0.02 mg/kg IV over 15 minutes and then 0.02 mg/kg/hr IV |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Posted for nasal surgeries
2.ASA physical status I and II
3. Elective surgeries |
|
| ExclusionCriteria |
| Details |
1. ASA physical status III and above
2. Heart disease and rhythm disturbances
3. psychiatric illness and anxiety disorder
4. History of post traumatic stress disorder
5. Emergency surgeries
6. Pregnancy
7. History of obstructive sleep apnea
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of emergence agitation between Inj Dexmedetomidine and Inj Midazolam group. |
At regaining consciousness, at extubation, every 5 minutes till 30 minutes are over |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare perioperative vitals, sedation and recovery profile |
At baseline, at 5 minutes, at 15 minutes after starting drug infusion then every 15 minutes till end of surgery. sedation and recovery profile at return of consciousness, at extubation and then every 5 minutes for 30 minutes. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
05/09/2016 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 randomised comparison between two drugs, Inj Midazolam and Inj Dexmedetomidine for prevention of emergence agitation following nasal surgeries. After obtaining valid informed consent patients will receive drug as per allotment group. For Group I, 100 mcg of Inj dexmedetomidine would be added into normal saline to make total volume of 50 mL. For Group II, 5 mg of inj midazolam would be added to normal saline to make total of 50 mL. Infusions will be started as per mentioned earlier. All standard monitors would be connected and vitasl will be monitored as mentioned in outcomes. General anaesthesia will be induced with inj propofol 2mg/kg, Fentanyl 2mcg/kg and vecuronium 0.1 mg/kg. Patients will be intubated with appropriate size entotracheal tube and will be maintained with oxygen , nitrous oxide, sevoflurane and inj vecuronium for relaxation. Additional analgesia will be decided by anaesthesiologist assigned to the case. Infusion and inhalational agents will be stopped at end of surgery when nasal packing is started. total duration of inhalational agent and time of discontinuation would be noted. Time from discontinuation to eye opening would be noted. patients would be reversed and extubated. Agitation score would be seen as per ’Riker’s agiatation sedation score’( RASS). Score of 5 and above will be taken as agitation and score of 3 and below will be taken as sedation.Patients would be monitored with same scale every 5 minutes for half an hour and then every 15 minutes for 2 hours. |