| CTRI Number |
CTRI/2020/05/025037 [Registered on: 05/05/2020] Trial Registered Prospectively |
| Last Modified On: |
02/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to compare different drugs with different routes in nasal surgery to compare blood loss, visiblity and better outcome. |
|
Scientific Title of Study
|
A Placebo Controlled Study To Compare The Hypotensive Effect Of Intravenous Dexmedetomidine Infusion Versus Premedication With Oral Metoprolol Under Sevoflurane Anaesthesia For Functional Endoscopic Sinus Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Chawla |
| Designation |
Professor Department Of Anaesthesia |
| Affiliation |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
| Address |
Department of Anaesthesiology and critical care sgrdimsar vallah
amritsar
Sri Guru Ramdas Institute Of Medical Sciences And
Research
Vallah
Amritsar
PUNJAB
143501
India
Amritsar
PUNJAB
143501
India |
| Phone |
9915530033 |
| Fax |
|
| Email |
drchawla30@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Chawla |
| Designation |
Professor Department Of Anaesthesia |
| Affiliation |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
| Address |
Department of Anaesthesiology and critical care sgrdimsar vallah
amritsar
Sri Guru Ramdas Institute Of Medical Sciences And
Research
Vallah
Amritsar
PUNJAB
143501
India
PUNJAB
143501
India |
| Phone |
9915530033 |
| Fax |
|
| Email |
drchawla30@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukhman Kaur Gill |
| Designation |
P G Resident Department Of Anaesthesia |
| Affiliation |
Sri Guru Ram Das Institute Of Medical Sciences And Research |
| Address |
department of anaesthesia
sri guru ram das institute of health sciences and research
vallah
amritsar
Amritsar
PUNJAB
143601
India |
| Phone |
6239705523 |
| Fax |
|
| Email |
sukhugill6666@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of anaesthesia
Sri Guru Ram Das Institute Of Medical Sciences And Research
vallah
amritsar |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 Sunil Chawla |
Sri Guru Ram das institute of Medical Sciences And Research |
main operation theratre
department of anaesthesia
sri guru ram das university of health sciences
vallah
amritsar
Amritsar
PUNJAB
Amritsar
PUNJAB |
9915530033
drchawla30@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethnics comittee Sri Guru Ram Das Institute Of Medical Sciences And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J019||Acute sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intravenous dexmedetomidine infusion versus premedication with oral metoprolol for hypotensive anaesthesia in patients undergoing FESS with sevoflurane anaesthesia |
to evaluate the efficacy of intravenous dexmedetomidine, oral metoprolo as a premedicant with inhalational sevoflurane for inducing hypotension in terms of mean arterial pressure and surgical field visibility |
| Comparator Agent |
to compare efficacy of intravenous dexmedetomidine infusion versus premedication with oral metoprolol versus placebo for hypotensive anaesthesia in patients unddergoing FESS under sevoflurane anaesthesia |
to evaluate the efficacy of intravenous dexmedetomidine, oral metoprolol as a premedicant with inhalational sevoflurane for inducing hypotension in terms of mean arterial pressure and surgical field visibility.
study will be conducted on 90 patients posted for functional ensoscopic sinus surgery with 3 groups of 30 each.
group A will be given intravenous infusion of dexmedetomidine intraoperatively loading dose 1mcg/kg over 10 minutes followed by maintainence dose of 0.2-0.5mcg/kg/hr.
group B will be given oral metoprolol as premedicant 50 mg orally night before surgery and 50 g orally 2 hours before surgery.
group C will be given placebo normal saline infusion at same rate and placebo tablets as premedication orally before surgery
anaesthesia will be given with sevoflurane |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status grade I and II |
|
| ExclusionCriteria |
| Details |
1. patients on any of the study drugs prior to surgery
2. patients with known hypersensitivity to study drugs
3. patients having history of drug abuse
4. patients who are mentally retarded
5. coagulation defects
6. conditions contraindicated for induced hypotension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the efficacy of intravenous dexmedetomidine, oral metoprolol as a premedicant with inhalational sevoflurane for inducing hypotension in terms of mean arterial blood pressure and surgical field visibility |
baseline, every minute for first 5 minutes, every 5 minutes for next 15 minutes and then every 15 minutes till the end of surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the incidence of intra-operative and post-operative complications associated with study drugs or technique of induced hypotension |
intraoperatively and upto 24 hours after surgery
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2020 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
a placebo controlled study to compare the hypotensive effect of intravenous dexmedetomidine infusion versus premedication with oral metoprolol under sevoflurane anaesthesia for functional endoscopic sinus surgery in terms of mean arterial pressure and surgical field visibility. study will be done on 90 patients psted for FESS with 30 patients in each 3 groups. group A will be given intravenous infusion of dexmedetomidine intraoperatively loading dose of 1mcg/kg followed by continuous infusion of 0.2-0.5mcg/kg/hr. group B will be given oral metoprolol as a premedicant 50 mg night before surgery and 50 mg 2 hours prior to surgery. group C will be given placebo. anaesthesia will be given by inhalational sevoflurane in all 3 groups and supplementing with propofol as needing for lowering blood pressure. intraopeartive hemodynamic parameters, blood loss, field visibility will be checked. post operative surgeons satisfaction score will be noted with complications occuring perioperatively. |