| CTRI Number |
CTRI/2025/10/095744 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on hemodynamic stability in patient undergoing general anaesthesia |
|
Scientific Title of Study
|
Comparison of Effects of Intravenous Dexmedetomidine and 2 percentage Lignocaine in Perioperative Hemodynamic stability and Post Operative Recovery profile in Laparoscopic Surgery
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
professor pushparani |
| Designation |
professor in department of anaesthesiology |
| Affiliation |
Professor |
| Address |
room no-5,4th floor,SRM medical college hospital and research centre,kattankulathur,chengalpattu district room no 5,4th floor,SRM medical college hospital and research centre,kattankulathur-603203 Chennai TAMIL NADU 603203 India |
| Phone |
9003242601 |
| Fax |
|
| Email |
pushpa82_dr@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Pushparani |
| Designation |
Professor in Department of Anaesthesiology |
| Affiliation |
Professor |
| Address |
room no 5,4th floor,SRM medical college hospital and research centre, kattankulathur,chengalpattu district,603203 SRM medical college hospital and research centre,kattankulathur,603203 Chennai TAMIL NADU 603203 India |
| Phone |
9003242601 |
| Fax |
|
| Email |
pushpa82_dr@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
yuvaraj p |
| Designation |
post graduate student |
| Affiliation |
PG |
| Address |
Room no5,4th floor,SRM medical college hospital and research centre, kattankulathur,603203 SRM medical college hospital and research centre,kattankulathur-603203 Chennai TAMIL NADU 603203 India |
| Phone |
9884420162 |
| Fax |
|
| Email |
yuvaraj5596@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre,Kattankulathur,Chengalpattu District.Pincode-603203 |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital and Research centre kattankulathurchengalpattu district |
| Address |
SRM medical college hospital and research centre 603203 |
| 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 |
| Yuvaraj P |
SRM Medical College Hospital and Research Centre |
SRM Medical College Hospital and Research Centre,Kattanl
kulathur,Chengalpattu District Chennai TAMIL NADU |
9884420162
yuvaraj5596@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 |
| Comparator Agent |
Group D Dexmedetomidine |
Patient in group D receive dexmedetomidine 0.5 microgram per kilogram loading dose over 10 minutes followed by 0.5 microgram per kilogram per hour infusion |
| Intervention |
group L- Lignocaine 2% |
Group-L receive lidocaine hydrochloride (1.5 mg/kg slow bolus, followed by 1.5 mg/kg/hr infusion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS I - II class patients.
Patients undergoing elective laparoscopic surgery.
surgical procedure duration less than 02 hours |
|
| ExclusionCriteria |
| Details |
patients refusal to be part of research.
Heart rate less than 60/min and MAP less than 65mmHg
History of hypersensitivity to the study drug.
chronic use of opioids/opioid addiction, steroids and inability to comprehend postoperatively the pain assessment scale.
Neuropsychiatric disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intravenous lignocaine may be equally effective in comparison with dexmedetomidine in providing perioperative hemodynamic stability and post operative pain relief without excess sedation |
Intravenous lignocaine may be equally effective in comparison with dexmedetomidine in providing perioperative hemodynamic stability and post operative pain relief without excess sedation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intravenous lignocaine may be equally effective in comparison with dexmedetomidine in providing perioperative hemodynamic stability & post operative pain relief without excess sedation |
from the time of premedication every three minutes for first
twenty minutes & then every ten minutes thereafter till extubation |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
01/11/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Aim is to compare the effects of intravenous lignocaine and dexmedetomidine on perioperative hemodynamic parameters in patients undergoing laparoscopic surgeries Primary objective is to analyse the effects of perioperative hemodynamic stability.Secondary objective is to analyse the intubation response,time to extubate,postoperative pain relief and pain at discharge from recovery in patients undergoing laparoscopic surgeries.A prospective,interventional,single centric, double blinded, randomized control trial.clinical study will be conducted after getting approval from the Institutional Ethical Committee.Patients were familiarized with the 10-point Visual Analog Scale VAS during the preanesthetic visit. In the operating room, standard multiparameter monitors were connected.Patients in Group D receive dexmedetomidine 0.5microgram per kilogram loading dose over 10 minutes, followed by 0.5 microgram per kilogram per hour infusion, while Group-L receive lidocaine hydrochloride 1.5 mg per kg slow bolus, followed by 1.5 milligram per kilogram per hour infusion,while Group-P 0.9 percentage Normal saline. Anesthetic induction was achieved with fentanyl 2.5 microgram per kilogram and propofol 2 milligram per kilogram until loss of verbal command. Endotracheal intubation was performed with Atracurium 0.5mg per kilogram. Anesthesia was maintained with an oxygen/air/sevoflurane mixture 1 MAC and atracurium. After induction continuous hemodynamic parameters is monitored in regular predefined time scale through out the procedure.Intraabdominal pressures,end tidal Co2 and MAC is monitored through out the procedure.After the specific specimen is out, then sevoflurane and study drug infusion will be stopped and extubation will stared after 20-30 minutes from the time of specimen out.Residual neuromuscular blockade was reversed with neostigmine 0.05 milligram per kilogram and glycopyrrolate 0.005 milligram per kilogram. Immediately after extubation, RASS and VAS score is assessedand 20 minutes after extubation repeat VAS will be monitored.Patients were transferred to the post anesthesia care unit PACU after successful tracheal extubation. Heart rate HR and mean arterial pressure MAP were monitored at regular intervals. Hypotension 20 percentage MAP fall below baseline) was managed with crystalloid boluses and Phenylepherine 10-50 microgram. Bradycardia HR < 45 beats/min was managed with IV atropine 0.6 milligram.
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