| CTRI Number |
CTRI/2024/08/072071 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to compare Dexmedetomidine with Midazolam as Sedative Agent in Medical Thoracoscopy. |
|
Scientific Title of Study
|
Randomized Control Study to compare the utility of Dexmedetomidine with Midazolam for conscious sedation in Medical Thoracoscopy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aswini Mohan |
| Designation |
MD student |
| Affiliation |
ESIC Medical College Hospital ,hyderabad |
| Address |
2nd year post graduate,Department of pulmonary medicine,ESIC medical college Hospital ,sanathnagar,Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9526941225 |
| Fax |
|
| Email |
tgmachus@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Surendar Reddy |
| Designation |
Proffesor and HOD |
| Affiliation |
ESIC Medical college Hospital ,Hyderabad |
| Address |
Department of pulmonary medicine,ESIC medical college Hospital,sanathnagar,Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9700565999 |
| Fax |
|
| Email |
surendark918@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Surendar Reddy |
| Designation |
Proffesor and HOD |
| Affiliation |
ESIC Medical college Hospital ,Hyderabad |
| Address |
Department of pulmonary medicine,ESIC medical college Hospital,sanathnagar,Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9700565999 |
| Fax |
|
| Email |
surendark918@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, Sanath nagar, Hyderabad, Telangana, India, 500038. |
|
|
Primary Sponsor
|
| Name |
Dr Aswini Mohan |
| Address |
2nd year post graduate,department of pulmonary medicine,ESIC Medical college and Hospital,Sanath nagar,Hyderabad,Telangana, India, 500038 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| K Surendar Reddy |
Proffesor and HOD,Department of Pulmonary Medicine,ESIC medical College and Hospital ,sanathnagar,Hyderabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aswini Mohan |
ESIC Medical College and Hospital |
Sixth floor, A side, Hospital block, Department of pulmonary medicine.
Hyderabad
TELANGANA |
9526941225
tgmachus@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESIC Institutional 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 |
Dexmedetomidine |
Inj.Dexmedetomidine 1 mcg/kg will be given intravenously over 10 minutes as loading dose before the initiation of the procedure, followed by maintenance infusion dose of 0.5 mcg/kg/h for 1 hour during medical thoracoscopy procedure. |
| Comparator Agent |
Midazolam |
Single dose of Inj.Midazolam 2mg intravenously will be given before initiation of the procedure of medical thoracoscopy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with pleural effusion undergoing medical thoracoscopy,Age 18years to 80years |
|
| ExclusionCriteria |
| Details |
Age less than 18 years,patients with known allergy or contraindication to study drugs,patients who donot give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare pulmonologist rated overall satisfaction on visual analogue scale for patients undergoing medical thoracoscopy under conscious sedation between dexmeditomedine and midazolam |
1hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the lowest mean oxygen saturation ,patient rated pain score for patients undergoing medical thoracoscopy under conscious sedation between dexmeditomedine and midazolam |
1h |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2 |
|
Date of First Enrollment (India)
|
21/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single blinded ,randomised controlled study to compare the utility of Dexmeditomedine with Midazolam for conscious sedation in Medical thoracoscopy conducted in the department of pulmonary medicine ,ESIC Medical college Hospital ,Hyderabad .Patients will be Randomised into study group and control group in 1:1 ratio ,allocation done using closed envelope method.Patients of control group receives inj Midazolam 2mg iv,while patients of study group receives will receive inj Dexmeditomedine 1mcg/kg over 10 minutes followed by infusion 0.5mcg/kg/h for 1hr during procedure.during procedure vitals will be monitored,sedation will be assessed by RAAS score,procedure satisfaction will be assessed by visual analogue scale from pulmonologist.procedural and post procedural pain will be analysed with Visual analogue scale from the patient for statistical comparison mean,standard deviation,percentage will be used and continous variable analysed with student t test and categorical variable by chisquare test |