| CTRI Number |
CTRI/2021/04/033097 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
24/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARISON OF POST-OPERATIVE ANALGESIC EFFICACY OF OPIOID FREE ANAESTHESIA USING INTRAVENOUS PARACETAMOL, LIGNOCAINE AND MAGNESIUM SULFHATE VERSUS STANDARD OPIOID ANAESTHESIA USING INTRAVENOUS TRAMADOL FOR PREEMPTIVE ANALGESIA IN ABDOMINAL SURGERIES UNDER GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
A COMPARISON OF EFFICACY OF OPIOID FREE ANAESTHESIA USING INTRAVENOUS PARACETAMOL(15MG/KG) VERSUS STANDARD OPIOID ANAESTHESIA USING INTRAVENOUS TRAMADOL(2MG/KG) IN ABDOMINAL SURGERIES UNDER GENERAL ANAESTHESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Surendran |
| Designation |
postgraduate student |
| Affiliation |
JLN medical college, Ajmer |
| Address |
Department of anaesthesia, JLN medical college, Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9446505237 |
| Fax |
|
| Email |
nehasurendran92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neena Jain |
| Designation |
Seniro Professor |
| Affiliation |
JLN medical college, Ajmer |
| Address |
Department of anaesthesia, JLN medical college, Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008666 |
| Fax |
|
| Email |
drneenaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neena Jain |
| Designation |
Seniro Professor |
| Affiliation |
JLN medical college, Ajmer |
| Address |
Department of anaesthesia, JLN medical college, Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008666 |
| Fax |
|
| Email |
drneenaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN medical college Ajmer |
|
|
Primary Sponsor
|
| Name |
JLN medical college Ajmer |
| Address |
Opp. Patel Stadium
Rajasthan
305001 |
| 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 Neha |
JLN medical colleage, Ajmer |
Department of anaesthesia, JLN medical college, Ajmer
Ajmer
RAJASTHAN |
9446505237
nehasurendran92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, JLN medical college |
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 |
Intravenous paracetamol(1gm), lignocaine (2mg/kg) and magnesium sulphate (50mg/kg) versus intravenous tramadol(2mg/kg) |
In this study, we will compare post-operative analgesic efficacy of opioid free anaesthesia (OFA) using paracetamol (15mg/kg), lignocaine (2mg/kg) and magnesium sulfate (50mg/kg) verses standard opioid anesthesia (OA) regimen using tramadol (2mg/kg) for preemptive analgesia in Abdominal surgeries under general anaesthesi. With, primary objective of 24hour post-operative analgesic consumption |
| Intervention |
Opioid free versus standard opioid anaesthesia |
Group A
Case (OFA group) Opioid free anesthesia (OFA) - Injection Lignocaine (2mg/kg)+ Injection MgSO4 (2gm/8mmol) + Injection Paracetamol (1gm) in 100 ml NS
Group B
Control (OA group) Opioid anesthesia (OA) control - injection
Tramadol(2mg/kg)+ injection Midazolam(0.2mg/kg) in 100 ml NS
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective Abdominal surgery under general anaesthesia.
Age between 18 to 65 years.
ASA physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
Pregnant or Breastfeeding women
Emergency surgery
Patients refusal.
Patient sensitive / allergic to any of the study drugs.
Patients with neuro-psychiatric illness.
Cardiovascular disease patients (1 and 2 degree heart block)
Patients on beta blockers.
Severe bradycardia (HR<50bpm) or LVF.
Severe hepatic and renal disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of our study will be the 24hour post-operative analgesic consumption in both the groups |
Outcome will be assessed at 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 16hr, 20hr and 24hr postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of analgesia using( NRS)
Duration of post-operative analgesia
Effect on hemodynamic parameters intraoperatively.
Stress response to laryngoscopy at the time of intubation.
Recovery time (Aldrete score 9)
QoR-15 (post- operative patient comfort)
Sedation (Ramsay sedation score)
Post operative nausea vomiting
Complications like pruritus, respiratory distress, sedation, bradycardia, hypotension. |
Outcomes will be assessed intraoperatively at baseline, 1, 2, 3, 5, 15, 30, 45, 60, 75, 90, 105, 120, 135 and 150 minutes. Postoperatively outcomes will be assessed at 0hr, 2hr, 4hr, 6hr, 8hr, 12hr, 16hr, 20hr and 24hr |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2021 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, we will compare post-operative analgesic efficacy of opioid free anaesthesia (OFA) using paracetamol (15mg/kg), lignocaine (2mg/kg) and magnesium sulfate (50mg/kg) verses standard opioid anesthesia (OA) regimen using tramadol (2mg/kg) for preemptive analgesia in Abdominal surgeries under general anaesthesia. PRIMARY OBJECTIVE: · 24hour post-operative analgesic consumption SECONDARY OBJECTIVES: · Quality of analgesia using (numeric rating scale NRS) · Duration of post-operative analgesia (time for demand of rescue analgesic) · Effect on hemodynamic parameters intraoperatively (Hypertension/hypotension or tachycardia/ bradycardia). · Stress response to laryngoscopy at the time of intubation. · Recovery time (Aldrete score >9) · QoR-15 (post- operative patient comfort) · Sedation (Ramsay sedation score) · Post operative nausea vomiting (PONV) · Complications like pruritus, respiratory distress, sedation, bradycardia (<50bpm), hypotension (decrease in SBP>30% baseline or <100mm Hg. |