| CTRI Number |
CTRI/2021/10/037396 [Registered on: 20/10/2021] Trial Registered Prospectively |
| Last Modified On: |
17/10/2021 |
| 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
|
Comparison of lidocaine and dexmedetomidine to see anaesthetic sparing effect in laparoscopic surgery |
|
Scientific Title of Study
|
Perioperative infusion of lidocaine vs dexmedetomidine - anaesthetic sparing effect in laparoscopic surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajeev Ranjan |
| Designation |
Junior Resident |
| Affiliation |
IGIMS |
| Address |
ward block, 1st floor, Department of Anesthesia and CCM ,IGIMS, Sheikpura , Patna ward block, 1st floor,Department of Anesthesia and CCM ,IGIMS, Sheikhpura, Patna Patna BIHAR 800014 India |
| Phone |
8603746104 |
| Fax |
|
| Email |
rjvranjan50@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mumtaz Hussain |
| Designation |
Additional Professor |
| Affiliation |
IGIMS |
| Address |
Ward block 1st floor , Department of Anesthesia and CCM,IGIMS , Sheikpura , Patna
Patna BIHAR 800014 India |
| Phone |
9473376853 |
| Fax |
|
| Email |
drhussain72@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Mumtaz Hussain |
| Designation |
Additional Professor |
| Affiliation |
IGIMS |
| Address |
Ward block 1st floor , Department of Anesthesia and CCM,IGIMS , Sheikpura , Patna
Patna BIHAR 800014 India |
| Phone |
9473376853 |
| Fax |
|
| Email |
drhussain72@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rajeev Ranjan |
| Address |
IGIMS , Sheikpura, Patna |
| Type of Sponsor |
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 |
| Rajeev Ranjan |
IGIMS , Patna |
Department of Anesthesia and CCM , ward block , 1st floor Patna BIHAR |
8603746104
rjvranjan50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
| Intervention |
Perioperative infusion of dexmedetomidine |
Patients in this group will receive a loading dose of iv. bolus dexmedetomidine 1mcg/kg diluted upto 20 ml by adding normal saline slowly for 10 minutes followed by iv. Infusion 0.5 mcg/kg/hr diluted upto 20 ml/hr till 10 min before the end of surgery. |
| Intervention |
Perioperative infusion of intravenous lidocaine |
Patients in this group will receive a loading dose of iv bolus lidocaine 1.5 mg/kg diluted upto 20 ml by adding normal saline slowly for 10 min followed by iv. Infusion 2mg/kg/hr diluted upto 20ml/hr using infusion pump till 10 min before the end of surgery. |
| Comparator Agent |
Perioperative infusion of normal saline |
Patients in this group will receive iv. Bolus 0.9% normal saline slowly for 10 minutes followed by iv. Infusion of normal saline 20ml/hr till 10 min before the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of ASA physical status I and II.
2. Patients willing to participate.
3. laproscopic surgery of different types under general anesthesia.
4. Patient between 18-65years of either sex . |
|
| ExclusionCriteria |
| Details |
a. Patients refusal to participate..
b. American Society of Anesthesiologists physical status of 3 or higher.
c. Patients with known allergy to any of the study drugs and
with cardiac conduction defects. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison between lidocaine vs dexmedetomidine regarding anaesthetic sparing effect in laproscopic surgery.
1.Propofol induction dose
2.End tidal isoflurane
3.Intra operative fentanyl required
4.Post operatively first analgesic demand |
anesthesia induction till und of surgery and the time to the first postoperative analgesic requirement in patients who undergo elective laparoscopic surgeries under general anesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Peri operative hemodynamic changes
• Post operative nausea, vomiting
• Bowel function (ileus)
• Bradycardia, if any |
anesthesia induction till und of surgery and the time to the first postoperative analgesic requirement in patients who undergo elective laparoscopic surgeries under general anesthesia. |
|
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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)
|
28/10/2021 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Lidocaine is an amide local anesthetic has analgesic, antihyperalgesic, and anti- inflammatory effects due to sodium channel blockade and inhibition of N-methyl- D-aspartate (NMDA) receptors [1]. Intravenous lidocaine provides pain relief after open abdominal surgery and laparoscopic surgery. [2] Use of perioperative lidocaine infusion include reductions in pain, nausea, ileus duration, opioid requirement, and length of hospital stay [3-8]. Lidocaine has a stabilizing effect on the heart and blood pressure, possibly by direct myocardial depressant effect, a peripheral vasodilating effect, and through its anti- inflammatory activity. [9] Dexmedetomidate, an imidazole compound is a pharmacologically active dextroisomer of medetomidine that displays specific and selective α2-adrenoceptor agonism. Activation of these receptors in the brain and spinal cord inhibits neuronal firing, causing hypotension, bradycardia, sedation, and analgesia. Dexmedetomidine is a specific alpha 2adrenergic receptor agonist that has anti- nociceptive and sedative properties. Intravenous dexmedetomidine has a role as postoperative analgesia, which leads to the reduced requirement for opioids [10-13] The goal of the current study is to compare the effects Perioperative lidocaine infusion is commonly used as analgesic adjunct in enhanced recovery protocols for patients undergoing laparoscopic surgeries to control the intraoperative and postoperative pain scores, decrease opioid consumption, and shorten length of hospital stay and increase patients comfort (Terkawi et al. 2016). Dexmedetomidine was a selective alpha 2 agonist as clonidine, but it has a greater affinity to the alpha 2 receptor with hypnotic properties similar to natural sleep and effectively attenuates the stress response to the surgical intervention with minimal or no respiratory depression complication. Also, maintained hemodynamic stability through its function on the central and peripheral alpha 2 receptors leads to reduction of heart rate and the systemic vascular resistance (Bos et al. 2017). of perioperative intravenous lidocaine and dexmedetomidine on the anesthetic consumption, anesthesia induction, recovery times, and the time to the first postoperative analgesic requirement in patients who undergo elective laproscopic surgeries under general anesthesia. |