| CTRI Number |
CTRI/2023/07/055404 [Registered on: 20/07/2023] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare total intravenous anaesthesia (propofol) with inhalational anaesthetic agent desflurane in terms of surgical field quality in functional endoscopic sinus surgery |
|
Scientific Title of Study
|
Comparison of total intravenous anesthesia with propofol versus desflurane as inhalational agent on surgical field quality in functional endoscopic sinus surgery: A randomized, prospective, comparative, observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aastha Shukla |
| Designation |
Post Graduate Student |
| Affiliation |
Fortis Hospital |
| Address |
First floor, Department of Anesthesia, Fortis hospital, Mohali
Rupnagar
PUNJAB
160062
India |
| Phone |
9599737177 |
| Fax |
|
| Email |
aastha4shukla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar Harish |
| Designation |
Consultant Anaesthesia |
| Affiliation |
Fortis Hospital |
| Address |
First floor, Department of Anesthesia, Fortis hospital, Mohali
Rupnagar
PUNJAB
160062
India |
| Phone |
9417661053 |
| Fax |
|
| Email |
hearty2brainy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Kumar Harish |
| Designation |
Consultant Anaesthesia |
| Affiliation |
Fortis Hospital |
| Address |
First floor, Department of Anesthesia, Fortis hospital, Mohali
Rupnagar
PUNJAB
160062
India |
| Phone |
9417661053 |
| Fax |
|
| Email |
hearty2brainy@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Fortis hospital, Sector 62, Phase 8, Mohali, Punjab-160062 |
|
|
Primary Sponsor
|
| Name |
Fortis hospital |
| Address |
Sector 62, Phase 8, Mohali |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Aastha Shukla |
Fortis hospital |
First floor, Department of Anesthesia, Fortis hospital, Mohali
Rupnagar
PUNJAB |
9599737177
aastha4shukla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Fortis hospital, Mohali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J349||Unspecified disorder of nose and nasal sinuses, (2) ICD-10 Condition: J329||Chronic sinusitis, unspecified, (3) ICD-10 Condition: J310||Chronic rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Desflurane as inhalational agent with dexmedetomidine as adjuvant |
Dexmedetomidine at 1mcg/kg for 10 mins as induction dose followed by 0.2mcg-0.7mcg/ kg as maintenance dose. It will be stopped once the dissection phase is over.
Desflurane as inhalational agent will be administered ac cording to the MAC of the drug and modified with BIS.
Rescue antihypertensive(Nitroglycerine) will be given whenever the required MAP is not reached. |
| Intervention |
Total intravenous anaesthesia with propofol for hypotensive anaesthesia with dexmedetomidine as adjuvant |
Dexmedetomidine at 1mcg/kg for 10 mins as induction dose followed by 0.2mcg-0.7mcg/ kg as maintenance dose.
Propofol will be given in the dose range of 50-150 mcg/kg/min and dose modification done as per BIS.
Both the drugs will be stopped at the end of dissection phase.
Rescue antihypertensive(Nitroglycerine) will be given whenever the required MAP is not reached. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age- 18 to 65 years of both gender
ASA grade I and II
undergoing Functional Endoscopic Sinus Surgery |
|
| ExclusionCriteria |
| Details |
Age <18 and >65 years
ASA grade III and IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| surgical field quality |
at 5 minutes, at 10 minutes, 20 minutes, at 30 minutes, at 40 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time of emergence from anaesthesia
2.Requirement of rescue hypotensive agent |
usage of rescue hypotensive agent to maintain mean arterial pressure between 55-65 mm Hg |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
27/07/2023 |
| 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="0"
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 study aims to compare the surgical field quality and emergence from anaesthesia in two groups of patients, one group receiving PROPOFOL and the other group receiving DESFLURANE. Both the groups will be receiving DEXMEDETOMIDINE infusion. Bispectral Index monitoring will be done to standardise the depth of anaesthesia in both groups.
To achieve bloodless surgical field during endoscopic sinus surgery, hypotensive anaesthesia plays a very crucial role. Controlled hypotension, defined as MAP of 55-65 mm Hg, , helps to control blood loss during surgery and improve the quality of surgical field by using anaesthetic and vasoactive agents. Total Intravenous Anaesthesia (TIVA) with propofol has long been used in endoscopic sinus surgeries to decrease intraoperative blood loss and reduce duration of surgery. The use of Dexmedetomidine has also been tried to achieve hypotensive anaesthesia in Functional Endoscopic Sinus Surgery. |