| CTRI Number |
CTRI/2024/12/078412 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of effect of opioid free anaesthesia with conventional opioid based anaesthesia in major spine surgery |
|
Scientific Title of Study
|
Comparison of effect of opioid free anaesthesia with conventional opioid based anaesthesia in major spine surgery : A Randomized Comparative trial |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Pramilla Soni |
| Designation |
Associate Professor |
| Affiliation |
Dr S N Medical college jodhpur |
| Address |
Dr SN MEDICAL COLLEGE department of anaesthesiology,
Sector-D, Shastri Nagar
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9468940551 |
| Fax |
|
| Email |
drpramila82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramila Soni |
| Designation |
Associate professor |
| Affiliation |
Dr S N Medical college jodhpur |
| Address |
Dr SN MEDICAL COLLEGE , Department of Anaesthesiology
Sector-D, Shastri Nagar, Jodhpur.
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9468940551 |
| Fax |
|
| Email |
drpramila82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Bhagyashree |
| Designation |
PG Student |
| Affiliation |
Dr S N Medical college jodhpur |
| Address |
Dr SN MEDICAL COLLEGE , Department of Anaesthesiology
Sector-D, Shastri Nagar, Jodhpur.
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9783805380 |
| Fax |
|
| Email |
dahiya.bhagyashree@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr SN MEDICAL COLLEGE department of anaesthesiology, Sector-D, Shastri Nagar, Jodhpur,
Rajasthan 342003 India
|
|
|
Primary Sponsor
|
| Name |
Dr SN Medical College jodhpur |
| Address |
Residency Rd, Sector-D, Shastri Nagar, Jodhpur, Rajasthan 342003 |
| Type of Sponsor |
Government 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 Bhagyashree |
Hospital |
Department of
Anaesthesiology
MDM and MGH Hospital spine OT
Jodhpur
RAJASTHAN |
09783805380
dahiya.bhagyashree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr SNMC Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G64||Other disorders of peripheral nervous system, (2) ICD-10 Condition: G64||Other disorders of peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Opioid Based group receive intravenous fentanyl |
Administration of fentanyl bolus 2mcg/kg bolus 3 minute prior to induction of anaesthesia followed by infusion fentanyl 0.5 mcg/kg/hours intraoperative period |
| Comparator Agent |
Opioid free group receive intravenous dexmedetomidine and lignocaine |
Administration of dexmedetomidine bolus 1mcg/kg 10 minutes prior to induction of anaesthesia followed by infusion 0.5 mcg/kg/hours and lignocaine 1mg/kg bolus 3 minutes prior to induction of anaesthesia followed by infusion 1mg/kg/hours during intraoperative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• The Patients of age ≥18-70 yrs of either gender of ASA category 1,2 and 3 undergoing major spine surgery under general anaesthesia who are haemodynamically stable and declared fit in pre- anaesthetics checkup. |
|
| ExclusionCriteria |
| Details |
Patient refusal, Patient having known history to allergy to dexmedetomidine, lignocaine and fentanyl and other anaesthetic drugs, patient with history of substance abuse, patient psychiatric illness, cardiac and hepatic insufficiency.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the total dose of rescue analgesic requirement up to 48 hours post operatively after major spine surgery. |
To compare the total dose of rescue analgesic requirement up to 48hours post operatively. From the time patient wakes up from anesthesia to 48
hours post operatively. When VAS is more than 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative pain intensity by visual analogue score in both the groups.
Hemodynamic stability and respiratory parameters (SBP, DBP, MAP, HR, SPO2).
The length of post operative hospital stays in both the groups.
The side effects such as nausea, vomiting, and respiratory depression, pruritus etc.
Post anaesthesia discharge scores according to modified aldrete score.
|
Modified aldrete score will be noted before discharge from post anaesthesia care unit.if score more than and equal to 9 patients will be dicharege. Haemodynamics and respiratory parameters and VAS will be noted on arrival in operation theater than every 15 minutes in intraoperative periods than every hourly upto 6 hours than every 4 hourly upto 24 hours than 6 hourly upto 48 hours. If any side effects and total duration of hospital stay will be also noted. |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
02/01/2025 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is to compare the effects of opioid free anaesthesia with conventional opioid based anaesthesia in patient undergoing to major spine surgery .
Two groups one is opioid based groups in which fentanyl is use as bolus before the induction of general anaesthesia and intravenous infusion of fentanyl will be started during intraoperative period. than all vital parameters and VAS will be noted .Second groups is opioid free groups in which Dexmedetomidine and lignocaine will be used as bolus and infusion during the intraoperative periods. And all haemodynamic parameters and VAS will be noted. than extubation done .Modified aldrete score will be noted in both the groups. Then total dose of rescue analgesia requirement will be noted upto the 48 hours in spine surgery. In rescue analgesia injection diclofenac intravenous given along with paracetamol infusion if VAS more than 4 and total doses of intravenous diclofenac will be compared in both groups. We will also noted the post operative pain intensity and SBP, DBP, MAP, HR, SPO2 upto 48 hours at specific interval time , side effects and total length of hospital stay , compare in both groups. These are compare in both groups. |