| CTRI Number |
CTRI/2022/01/039288 [Registered on: 10/01/2022] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy of opioid free anaesthesia vs opioid anaesthesia in terms of post-op VAS score, hemodynamic stability, postoperative nausea and vomiting,and sedation score |
|
Scientific Title of Study
|
comparision of efficacy of opioid free anaesthesia vs conventional opioid anaesthesia for nasal surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hariharan |
| Designation |
Post graduate resident |
| Affiliation |
Sri ramachandra institute of higher education and research center,Porur, Chennai-600116 |
| Address |
department of anaethesiology,Sri ramachandra institute of higher education and research center,Porur,chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9443371594 |
| Fax |
|
| Email |
5594hariharanmbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr aruna parameswari |
| Designation |
head of the department |
| Affiliation |
Sri ramachandra institute of higher education and research center,Porur, Chennai-600116 |
| Address |
department of anaethesiology, Sri ramachandra institute of higher education and research center,Porur,chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9840529863 |
| Fax |
|
| Email |
reetharun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hariharan |
| Designation |
Post graduate resident |
| Affiliation |
Sri ramachandra institute of higher education and research center,Porur, Chennai-600116 |
| Address |
department of anaesthesiology,Sri ramachandra institute of higher education and research center,Porur,chennai
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9443371594 |
| Fax |
|
| Email |
5594hariharanmbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri ramachandra institute of higher education and research center, Porur chennai |
|
|
Primary Sponsor
|
| Name |
hariharan |
| Address |
Department of anesthesiology ,Sri ramachandra institute of higher education and research center |
| Type of Sponsor |
Other [other (self)] |
|
|
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 hariharan |
Sri ramachandra institute of higher education and research center |
department of anaethesiology,Sri ramachandra institute of higher education and research center, Porur, Chennai
Kancheepuram
TAMIL NADU |
9443371594
5594hariharanmbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri ramachandra University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional opioid based Anesthesia using inj fentanyl iv is comaprator agnet |
conventional opioid based Anesthesia - inj fentanyl iv given 2mcg/kg 3minutes prior to intubation |
| Intervention |
Inj dexmedetomidine iv/inj lignocaine iv(opioid free Anesthesia protocol) |
Study is going to conduct in Patient undergoing nasal surgery under general anaesthesia-inj dexmedetomidine iv loading dose 1mcg/kg over 10minutes followed by 0.2 to 0.7mcg/kg maintance dose till surgery gets over, i.v lignocaine 1.5mg/kg throughout intraoperative period till surgery gets over |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Elective Nasal surgeries (septoplasty/ FESS)
2.Patient belonging to ASA class I and II
|
|
| ExclusionCriteria |
| Details |
•Patients with ASA class III and IV
•Patient with endorgan dysfunction
•Hemodynamically unstable patients
•Emergency cases
•Pregnant and lactating women
•Patients on α blocker and patients with HR <55/min.
•Asthmatic patients
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postop Analgesic efficacy - Postopertive pain for 24 hours |
Postop Analgesic efficacy - Postopertive pain for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intraoperative hemodynamics
2.Intraoperative sevoflurane requirements to maintain adequate BIS (end tidal values) – data captured every 15 min
3.Intraoperative bleeding in the surgical field
4.Post operative nausea and vomiting
5.Postop sedation |
I/O hemodynamics will be assessed-T0(prior to infusion of study drug),T1(at completion of infusion of study drug)
,T2(after administration of induction agent),T3(immediately after intubation),T4 (at the start of the procedure)
,T5,T6 &T7(15 min,30 min &60 min after procedure starts),T8(Immediately after extubation),T9,T10(5 min,30 min after extubation)
PONV &Postop sedation will be assessed on 30 mins,1st hour,1 and half hours,2,4,6,8,12,24th hour |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2022 |
| Date of Study Completion (India) |
10/07/2022 |
| Date of First Enrollment (Global) |
15/01/2022 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Cureus2023 Jul 24;15(7):e42409.
doi: 10.7759/cureus.42409. eCollection 2023 Jul. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
INTRODUCTION • Opioid free anesthesia in bariatric surgery has been shown to be associated with quicker recovery during the post operative period, shorter hospital stay with consequent reduction in health care cost, early ambulation of patients and minimization of side effects of opioids. Similar such benefits are being shown in other surgeries • we compare the efficacy of opioid free anesthesia with conventional opioid based anesthesia for nasal surgeries. PRIMARY OUTCOME is measure • Postop Analgesic efficacy - Postopertive pain for 24 hours (VAS every 30 min for first 2 hours in PACU, then at 4,6,8,12,24 hours) SECONDARY OUTCOME is to measure • Intraoperative hemodynamics • Intraoperative sevoflurane requirements to maintain adequate BIS (end tidal values) – data captured every 15 min • Intraoperative bleeding in the surgical field • PONV• Postop sedation
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