| CTRI Number |
CTRI/2021/04/032968 [Registered on: 20/04/2021] Trial Registered Prospectively |
| Last Modified On: |
19/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of IV dexmedetomidine and lidocaine for analgesic (painkiller) requirement in patients undergoing laparoscopic surgeries |
|
Scientific Title of Study
|
Comparing efficacy of intravenous dexmedetomidine and lidocaine on perioperative analgesic consumption in patients undergoing Laparoscopic surgery |
| Trial Acronym |
IDLIS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashita Mowar |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
OT Complex, First Floor, Department of Anaesthesiology, Shri Ram Murti Smarak Institute Of Medical Sciences, Bhojipura, Barielly- Nainital Road, Barielly
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9568578724 |
| Fax |
|
| Email |
drash.royals@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashita Mowar |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
OT Complex, First Floor, Department of Anaesthesiology, Shri Ram Murti Smarak Institute Of Medical Sciences, Bhojipura, Barielly- Nainital Road, Barielly
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9568578724 |
| Fax |
|
| Email |
drash.royals@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashita Mowar |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
OT Complex, First Floor, Department of Anaesthesiology, Shri Ram Murti Smarak Institute Of Medical Sciences, Bhojipura, Barielly- Nainital Road, Barielly
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9568578724 |
| Fax |
|
| Email |
drash.royals@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ram Murti Smarak Institute of Medical Sciences, Bhojipura, Barielly- Nainital Road, Barielly, Uttar Pradesh- 243202 |
|
|
Primary Sponsor
|
| Name |
Shri Ram Murti Smarak Institute of Medical Sciences |
| Address |
Shri Ram Murti Smarak Institute of Medical Sciences, Bhojipura, Barielly- Nainital Road, Barielly, Uttar Pradesh- 243202 |
| 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 Ashita Mowar |
Shri Ram Murti Smarak Institute Of Medical Sciences |
OT Complex, First Floor, Department of Anaesthesiology, Shri Ram Murti Smarak Institute Of Medical Sciences, Bhojipura, Barielly- Nainital Road, Barielly
Bareilly
UTTAR PRADESH |
9568578724
drash.royals@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Dexmedetomidine |
In Group-D dexmedetomidine loading infusion (1µg/kg) will be administered over 10 min followed by continuous IV infusion at 0.5 mcg/kg/h. |
| Comparator Agent |
Intravenous Lignocaine |
Group-L will receive a bolus of 1.5 mg/kg lidocaine hydrochloride 2% (400 mg/20 ml) slowly followed by a continuous intravenous infusion of 2 mg/kg/h lidocaine |
| Comparator Agent |
Intravenous Normal Saline |
Group N will receive normal saline as infusion by same method. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A total of 93 patients aged 18-60 yrs. of either sex with ASA physical status I/II undergoing elective laparoscopic surgeries will be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
patient refusal, hypersensitivity to the drugs being evaluated, Body Mass Index (BMI) more than 40 kg/m2, pregnancy, significant comorbid conditions like uncontrolled hypertension, congestive heart failure, myocardial infarction in the past 6 months, heart block, fixed cardiac output lesions, chronic liver or kidney illnesses and chronic use of opioids/opioid addiction, steroids, or inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders, patients requiring inotropes or antihypertensive medications intraoperatively. |
|
|
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 |
| The primary outcome measure of our study is to compare the analgesic effects of intraoperative lidocaine and dexmedetomidine infusion on intraoperative and immediate postoperative opioid consumption in patients undergoing laparoscopic surgeries and assessing the VAS at predetermined points i.e., immediately after tracheal extubation, 15 min, 30 min and then hourly until the first rescue analgesic. Mean and cumulative VAS scores and sedation scores shall be compared between the three groups. |
immediately after tracheal extubation, 15 min, 30 min and hourly until the first rescue analgesic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome measures include analysing intraoperative hemodynamic profile (heart rate and mean arterial pressure) and incidence of adverse effects including intraoperative and postoperative hemodynamic changes, post-operative constipation, sedation, pruritus, PONV and analyzing recovery profile (by comparing RASS at predetermined end points |
At baseline(0), induction, tracheal-intubation, before pneumoperitoneum, 15-minute intervals, end-surgery in both groups, immediately after tracheal extubation, 15 min ,30 min, and hourly till RASS score zero. |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
23/04/2021 |
| 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="0"
Months="6"
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)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drash.royals@gmail.com].
- For how long will this data be available start date provided 18-01-2022 and end date provided 18-01-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This prospective randomized double blinded study will carried out on 93 patients in the age group of 18 to 60 yrs of either sex ASA physical status I and II who will be undergoing elective laproscopic surgery. The patients will be divided into three groups which will recieve intravenous dexmedetomidine lignocaine and normal saline. The primary outcome of the study is to compare the analgesic effects of intraoperative lignocaine and dexmedetomidine infusion on intraoperative and immediate post operative opioid consumption. The secondary outcome will include hemodynamics and incidence of adverse effects if any |