| CTRI Number |
CTRI/2024/04/066065 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Providing anesthesia without using opioids for all nose surgeries |
|
Scientific Title of Study
|
Opioid Free anethesia for nasal surgeries A comparative 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 |
Sahana S |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri institute of Medical Sciences and Research Centre |
| Address |
Department of Anesthesia Fourth Floor Sapthagiri Institute of Medical Sciences and Research Centre Navy Layout Hesarghatta Main Road Chikkabanavara
Bangalore
KARNATAKA
560090
India |
| Phone |
7619304166 |
| Fax |
|
| Email |
sahanasuresh1320@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nandini R |
| Designation |
Assistant Professor |
| Affiliation |
Sapthagiri institute of Medical Sciences and Research Centre |
| Address |
Department of Anesthesia Ground Floor Sapthagiri Institute of Medical Sciences and Research Centre Navy Layout Hesarghatta Main Road Chikkabanavara
Bangalore
KARNATAKA
560090
India |
| Phone |
9740576516 |
| Fax |
|
| Email |
nandyrags21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nandini R |
| Designation |
Assistant Professor |
| Affiliation |
Sapthagiri institute of Medical Sciences and Research Centre |
| Address |
Department of Anesthesia Ground Floor Sapthagiri Institute of Medical Sciences and Research Centre Navy Layout Hesarghatta Main Road Chikkabanavara
Bangalore
KARNATAKA
560090
India |
| Phone |
9740576516 |
| Fax |
|
| Email |
nandyrags21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute of Medical Sciences and Research Centre Department of Anesthesiology GrounD Floor OT Complex |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute Of Medical Sceinces and Research Centre |
| Address |
Navy Layout Hesarghatta Main Road Chikkabanavara |
| 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 Sahana S |
Sapthagiri Institute Of Medical Sceinces and Research Centre |
Department of Anesthesiology Fourth Floor OT Complex Hesarghatta Main Road Chikkabanavara
Bangalore
KARNATAKA |
7619304166
sahanasuresh1320@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute Of Medical Sceinces and Research Centre |
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 |
| Comparator Agent |
Opioid based anesthesia |
Drugs used for analgesia is opioid according to their body weight |
| Intervention |
Opioid free anesthesia |
Drugs used for analgesia are paracetamol, lignocaine(preservative free), Magnesium sulphate and dexmeditomidine according to there body weight |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2, undergoing elective bilateral functional endoscopic sinus surgery |
|
| ExclusionCriteria |
| Details |
Allergy/contraindication to any drugs used in this study
Bleeding disorders
Unstable hemodynamics
Pregnant patients
Patients currently taking opioid for chronic pain Patients with asymptomatic sinus bradycardia Patients with OSA, obesity, difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of post operative analgesia in both the groups for 1st 24 hours |
Duration of post operative analgesia in both the groups for 1st 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparition of both groups with respect to post operative nausea and vomiting, hemodynamics stability |
post operative nausea and vomiting episodes |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| 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="0"
Months="2"
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
|
Functional endoscopic sinus surgery (FESS) is the most commonly performed otolaryngological procedures .This surgery is usually conducted under general anesthesia under controlled hypotension improve surgical field and to increases the likelihood of successful surgery. Opioid-sparing techniques are gaining popularity among anesthesiologist due to opioid related side effects. Here we are comparing opioid free and opioid based general anesthesia groups in nasal surgeries with respect to post-operative analgesia, post operative nausea and vomiting, hemodynamics stability. Results of this study will guide us about the benefits and advantages of opioid free anesthesia.
|