| CTRI Number |
CTRI/2017/03/008077 [Registered on: 14/03/2017] Trial Registered Prospectively |
| Last Modified On: |
27/02/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of two drugs, dexmedetomidine and esmolol as blood pressure controlling agents in patients undergoing ENT surgeries. |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of dexmedetomidine as a hypotensive agent in comparison to esmolol in ASA grade 1-2 patients undergoing ENT 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 Shilpa Bansal |
| Designation |
Assistant professor |
| Affiliation |
Adesh university |
| Address |
Dept of Anaesthesiology and intensive care
Adesh institute of medical sciences and research
Adesh university
Barnala road bathinda 151001
Punjab
Barnala road bathinda
Punjab 151001
Bathinda
PUNJAB
151001
India |
| Phone |
09915433522 |
| Fax |
|
| Email |
Shilpa_shinde24@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Bansal |
| Designation |
Assistant professor |
| Affiliation |
Adesh university |
| Address |
Dept of Anaesthesiology and intensive care
Adesh institute of medical sciences and research
Adesh university
Barnala road bathinda 151001
Punjab
Barnala road bathinda
Punjab 151001
Bathinda
PUNJAB
151001
India |
| Phone |
09915433522 |
| Fax |
|
| Email |
Shilpa_shinde24@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Bansal |
| Designation |
Assistant professor |
| Affiliation |
Adesh university |
| Address |
Dept of Anaesthesiology and intensive care
Adesh institute of medical sciences and research
Adesh university
Barnala road bathinda 151001
Punjab
Barnala road bathinda
Punjab 151001
Bathinda
PUNJAB
151001
India |
| Phone |
09915433522 |
| Fax |
|
| Email |
Shilpa_shinde24@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and intensive care
Adesh Institute of medical sciences, Adesh University,
Barnala road bathinda |
|
|
Primary Sponsor
|
| Name |
Dr Shilpa bansal |
| Address |
Assistant prof. Dept of anaesthesiology and intensive care, Adesh Institute of medical sciences,Barnala road bathinda Punjab |
| 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 shilpa bansal |
Dept of ENT and dept. of Anaesthesiology and Intensive care |
adesh institute of medical sciences and research,
adesh university, barnala road bathinda
Bathinda
PUNJAB |
9915433522
shilpa_shinde24@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, Adesh University, bathinda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grade I-II patients of both sexes aged between 18-60 yrs, undergoing Otorhinolaryngeal (ENT) surgeries., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INJ. DEXMEDITOMIDINE |
Patients in D group(assigned to receive dexmedetomidine )
will receive loading dose of 1 μg/kg dexmedetomidine diluted in 10 ml 0.9% saline infused over 10 min before starting of surgery, followed by continous infusion (0.4- 0.8 μg/kg/h).
|
| Intervention |
INJ. ESMOLOL |
Patients in E group (assigned to receive esmolol) patients will receive esmolol as a loading dose (1 mg/kg) infused over 1 min followed by continuous infusion of (0.4-0.8 mg/kg/h).
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18- 60 yrs of both the sexes, undergoing planned Otorhinolaryngeal (ENT) surgeries with ASA grade I-II. |
|
| ExclusionCriteria |
| Details |
1.Patients refusing to give informed consent.
2.Patients with recurrent sinus surgery and patients with systemic co-morbidities like hypertension, coronory artery disease, renal or hepatic disease, cerebro vascular accidents.
3.Patients with coagulopathies or receiving drugs which have effects on coagulation profile.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| primary outcome is to compare the quality of the surgical field using a predefined category scale |
surgical field score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the efficacy and safety of dexmedetomidine with Esmolol as a hypotensive agent in ENT surgeries with attention on analgesia requirement, recovery profile, and tolerability in adult patients. |
sedation score, visual analogue score, modified aldrete score |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2017 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective, randomised ,double blind, parallel group with active controlled trial to compare
the efficacy and safety of dexmedetomidine with
Esmolol as a hypotensive agent in 60 (30 in each group) ASA grade I-II patients of both sexes aged between 18-60 yrs, undergoing Otorhinolaryngeal (ENT) surgeries with attention on the
amount of blood loss, quality of the surgical field as primary outcome measures and analgesia requirement, recovery profile, and
tolerability in adult patients as secondary outcome measures. |