| CTRI Number |
CTRI/2020/07/026711 [Registered on: 21/07/2020] Trial Registered Prospectively |
| Last Modified On: |
20/07/2020 |
| 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
|
A STUDY TO COMPARE THE EFFECTS BETWEEN DEXMEDETOMIDINE AND ESMOLOL TO REDUCE THE BLOOD PRESSURE, INTURN DECREASING THE BLOOD LOSS DURING SURGERIES OF NOSE AND TO FIND OUT WHICH AMONGST THESE TWO IS SAFE AND BETTER. |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF EFFECT OF LOW DOSE DEXMEDETOMIDINE INFUSION WITH THAT OF LOW DOSE ESMOLOL INFUSION ON INTRAOPERATIVE HEMODYNAMICS, ANESTHETIC REQUIREMENTS AND RECOVERY PROFILE IN PATIENTS UNDERGOING NASAL SURGERIES – A DOUBLE BLIND RANDOMIZED STUDY IN TERTIARY CARE CENTRE. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHRIDEVI GUDI |
| Designation |
POST GRADUATE |
| Affiliation |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES, BENGALURU |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES, NO.15, CHIKKASANDRA, HESARAGHATTA MAIN ROAD
POST GRADUATE GIRLS HOSTEL,SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES, NO.15, CHIKKASANDRA, HESARAGHATTA MAIN ROAD
Bangalore
KARNATAKA
560090
India |
| Phone |
8147402996 |
| Fax |
|
| Email |
sggudi2908@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ASHWINI H |
| Designation |
PROFESSOR |
| Affiliation |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES, BENGALURU |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES, NO.15, CHIKKASANDRA, HESARAGHATTA MAIN ROAD
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES, NO.15, CHIKKASANDRA, HESARAGHATTA MAIN ROAD
Bangalore
KARNATAKA
560090
India |
| Phone |
8971265579 |
| Fax |
|
| Email |
drashwinih@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHRIDEVI GUDI |
| Designation |
POST GRADUATE |
| Affiliation |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES, BENGALURU |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES, NO.15, CHIKKASANDRA, HESARAGHATTA MAIN ROAD
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES, NO.15, CHIKKASANDRA, HESARAGHATTA MAIN ROAD
Bangalore
KARNATAKA
560090
India |
| Phone |
8147402996 |
| Fax |
|
| Email |
sggudi2908@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute of medical sciences and research centre |
|
|
Primary Sponsor
|
| Name |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANESTHESIOLOGY NO.15, HESARAGHATTA ROAD, CHIKKASANDRA, BENGALURU- 560090 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shridevi Gudi |
SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ANESTHESIOLOGY SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES, NO.15, CHIKKASANDRA, HESARAGHATTA MAIN ROAD
Bangalore
KARNATAKA |
8147402996
sggudi2908@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE(HUMAN) AT SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M950||Acquired deformity of nose, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Esmolol |
Inducing controlled hypotension using Esmolol 0.3mg/kg bolus and 0.03mg/kg/hr infusion and dexmedetomidine 0.3mcg/kg bolus and 0.3mcg/kg/hr infusion |
| Intervention |
induced hypotension |
Inducing controlled hypotension using low dose Dexmedetomidine 0.3mcg/kg bolus and 0.3mcg/kg/hr infusion and esmolol 0.3mg/kg bolus and 0.03mg/kg/hr infusion to reduce mean arterial pressure so as to provide clear surgical field and decrease the requirement of anesthetic agents, enhancing the recovery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.American society of anaesthesiologists (ASA) grade 1 and 2 patients aged 20-50 years undergoing nasal surgeries under general anaesthesia
2.Patients willing to give consent |
|
| ExclusionCriteria |
| Details |
1.Pregnant women
2.Allergy to the study drugs
3.Morbidly obese patients with body mass index (BMI) >30 kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of low dose dexmedetomidine infusion with that of low dose esmolol infusion on the intraoperative hemodynamic profile, blood loss during surgery and emergence from anesthesia. |
Maintaining Mean arterial pressure of 65-70mmHg throughout the surgery and measuring once every 5 minutes for the initial 20 minutes and once every 10 minutes thereafter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of these infusions on intraoperative anesthetic and analgesic requirements. |
Concentration of sevoflurane in % recorded once every 5 minutes for initial 20 minutes and once every 10 minutes thereafter |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2020 |
| 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="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
COMPARATIVE STUDY OF EFFECT OF LOW DOSE DEXMEDETOMIDINE INFUSION WITH THAT OF LOW DOSE ESMOLOL INFUSION ON INTRAOPERATIVE HEMODYNAMICS, ANESTHETIC REQUIREMENTS AND RECOVERY PROFILE IN PATIENTS UNDERGOING NASAL SURGERIES – A DOUBLE BLIND RANDOMIZED STUDY IN TERTIARY CARE CENTRE.Good surgical field visibility is one of the basic prerequisites for precise and safe otorhinolaryngological operations. Controlled hypotension (CH) at a moderate level (mean blood pressure –MAP 65-70mmHg) is often preferred during nasal surgical procedures such as Functional Endoscopic Sinus Sugery (FESS) and septorhinoplasty in order to reduce hemorrhaging and thus reduce complications via improved surgical field visibility.
This study is primarily designed to evaluate and compare the effect of the infusion of low dose esmolol with that of low dose dexmedetomidine on the intraoperative hemodynamic profile, blood loss during nasal surgery and emergence from anesthesia.
Objectives of the study: 1) To compare the efficacy of low dose dexmedetomidine infusion with that of low dose esmolol infusion on the intraoperative hemodynamic profile, blood loss during surgery and emergence from anesthesia. 2) To evaluate the effect of these infusions on intraoperative anesthetic and analgesic requirements. |