| CTRI Number |
CTRI/2020/07/026378 [Registered on: 06/07/2020] Trial Registered Prospectively |
| Last Modified On: |
03/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Opioid Free Anaesthesia for Postoperative Pain control in Bariatric Surgery |
|
Scientific Title of Study
|
Randomized Controlled Trial on Comparison of Opioid Free Anaesthesia versus Opioid Anaesthesia for Postoperative Pain Control and Intubation Stress Attenuation in Laparoscopic Sleeve Gastrectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prabhakaran Subramaniam |
| Designation |
Consultant |
| Affiliation |
GEM Hospital and research centre,Coimbatore |
| Address |
No 45,Department of bariatric(metabolic) Surgery,Gem Hospial,Pankaja mill road,Ramanathapuram,Coimbatore
No 45,Gem Hospial,Pankaja mill road,Ramanathapuram,Coimbatore
Coimbatore
TAMIL NADU
641015
India |
| Phone |
9894282831 |
| Fax |
|
| Email |
prabhakar.s.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhakaran Subramaniam |
| Designation |
Consultant |
| Affiliation |
GEM Hospital and research centre,Coimbatore |
| Address |
No 45,Gem Hospial,Pankaja mill road,Ramanathapuram,Coimbatore
No 45,Gem Hospial,Pankaja mill road,Ramanathapuram,Coimbatore
Coimbatore
TAMIL NADU
641015
India |
| Phone |
9894282831 |
| Fax |
|
| Email |
prabhakar.s.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhakaran Subramaniam |
| Designation |
Consultant |
| Affiliation |
GEM Hospital and research centre,Coimbatore |
| Address |
No 45,Gem Hospial,Pankaja mill road,Ramanathapuram,Coimbatore
No 45,Gem Hospial,Pankaja mill road,Ramanathapuram,Coimbatore
Coimbatore
TAMIL NADU
641015
India |
| Phone |
9894282831 |
| Fax |
|
| Email |
prabhakar.s.doc@gmail.com |
|
|
Source of Monetary or Material Support
|
| GEM Hospital and Research centre,Coimbatore |
|
|
Primary Sponsor
|
| Name |
GEM Hospital and Research centre |
| Address |
No 45,Gem Hospial,Pankaja mill road,Ramanathapuram,Coimbatore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| GEM Hospital and Research centre |
No 45,Gem Hospial,Pankaja mill road,Ramanathapuram,Coimbatore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabhakaran |
GEM Hospital and Research centre |
No 45,Gem Hospial,Pankaja mill road,Ramanathapuram,Coimbatore
Coimbatore
TAMIL NADU |
9894282831
prabhakar.s.doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gem hospital and research centre, Coimbatore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Opioid free anaesthesia vs opioid anaesthesia |
Opioid free anaesthesia in one group and opioid anaesthesia in other,opioid group will contain fentanyl 2mcg/kg during induction,whereas opioid free group will not have fentanyl,instead will be having dexmedetomidine bolus 0.5 mcg/ kg ,30 minutes before induction and dexmedetomidine infusion 0.2-0.7 mcg/kg after induction intraoperatively, both groups will contain paracetamol 15mg/kg and lignocaine 1-2mg/kg,given 10 minutes before intubation in opioid free anaesthesia group,and after intubation intraoperatively in opioid group respectively.Diclofenac ,dexamethasone,ondansetron,and local anaesthesia infiltration were given in both groups intraoperatively |
| Comparator Agent |
Opioid free anaesthesia vs opioid anaesthesia |
Opioid free anaesthesia in one group and opioid anaesthesia in other,opioid group will contain fentanyl 2mcg/kg during induction,whereas opioid free group will not have fentanyl,instead will be having dexmedetomidine bolus 0.5 mcg/ kg ,30 minutes before induction and dexmedetomidine infusion 0.2-0.7 mcg/kg after induction intraoperatively, both groups will contain paracetamol 15mg/kg and lignocaine 1-2mg/kg,given 10 minutes before intubation in opioid free anaesthesia group,and after intubation intraoperatively in opioid group respectively.Diclofenac ,dexamethasone,ondansetron,and local anaesthesia infiltration were given in both groups intraoperatively |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 25 to 60 years |
|
| ExclusionCriteria |
| Details |
Patients with severe bradycardia,uncontrolled hypertension,heart blocks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare pain score between two groups |
Different time points,Immediately after extubation followed by half an hour hourly for two hours,then fourth hourly for till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intubation stress response,discharge readiness,post operative opioid consumption,sedation score,post operative nausea and vomiting |
Different time points,immediately after intubation followed by every minute for ten minutes,postoperatively every half an hour for two hours followed by every fourth hourly till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2 |
|
Date of First Enrollment (India)
|
09/07/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anaesthetic challenge in bariatric surgery includes postoperative pain relief as its vital component. Owing to have better pain control, early mobilisation and faster recovery it is better to reduce the use of respiratory depressants. Furthermore, perioperative cognitive dysfunction and opioid induced hyperalgesia remains a concern with any opioid based technique. Therefore our study aims at comparing opioid free anaesthesia for postoperative pain relief and attenuation of intubation stress response with opioid anaesthesia group in patients undergoing laparoscopic sleeve gastrectomy. |