| CTRI Number |
CTRI/2025/04/083772 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing injection of Dexmedetomidine and Lidocaine for Pain Relief in Women Undergoing Laparoscopic Surgery |
|
Scientific Title of Study
|
Comparison of Intravenous Dexmedetomidine and Lidocaine
infusion for Perioperative Analgesic Consumption in Patient’s Undergoing
Laparoscopic Gynaecological Surgeries: A Randomized Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Fathima beevi |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, AIIMS Campus, Saket Nagar, Bhopal, Madhya Pradesh, 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8825507833 |
| Fax |
|
| Email |
hussain30734@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranita Mandal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, AIIMS Campus, Saket Nagar, Bhopal, Madhya Pradesh, 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8800768428 |
| Fax |
|
| Email |
pranita.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranita Mandal |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anaesthesiology, AIIMS Campus, Saket Nagar, Bhopal, Madhya Pradesh, 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
8800768428 |
| Fax |
|
| Email |
pranita.anesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES,BHOPAL,MADHYA PRADESH,INDIA,462020 |
|
|
Primary Sponsor
|
| Name |
Dr Pranita Mandal |
| Address |
Department Of Anaesthesiology, AIIMS Bhopal, Saket Nagar,Bhopal. |
| 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 |
| Dr Fathima beevi |
AIIMS Bhopal |
Modular Operation Theatre, Department Of Anaesthesiology, AIIMS Bhopal
Bhopal
MADHYA PRADESH |
8825507833
hussain30734@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Student Research AIIMS Bhopal |
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 |
Group D: Intravenous infusion Dexmedetomidine 1mcg/kg over 10 minutes before anaesthesia induction followed by 0.3 mcg/kg/hour after anaesthesia induction. |
On the day of surgery, patients will be premeditated with i.v. glycopyrrolate 4mcg/kg. Study drug bolus infusion over 10 min will be started as per group allocation. After this initial study drug bolus, general anaesthesia will then be instituted with inj. ketamine 0.5mg/kg, injections. propofol 1.5 mg/kg, injections. rocuronium 0.6 mg/kg and endotracheal intubation. Maintenance will be as per institution protocol. Hemodynamic parameters, will be recorded at baseline, before the start of the study drug, 10 min after start of the study drug, after induction, during intubation, prior and after pneumoperitoneum and then every 15 min till the end of the surgery. After successful tracheal extubation, all patients will be transferred to PACU for further monitoring at predefined intervals. |
| Comparator Agent |
Group L: Intravenous infusion 2% Lidocaine hydrochloride 1.5 mg/kg over 10 minutes before anaesthesia induction followed by 1.5 mg/kg/hour after anaesthesia induction. |
On the day of surgery, patients will be premeditated with i.v. glycopyrrolate 4mcg/kg. Study drug bolus infusion over 10 min will be started as per group allocation. After this initial study drug bolus, general anaesthesia will then be instituted with inj. ketamine 0.5mg/kg, injections. propofol 1.5 mg/kg, injections. rocuronium 0.6 mg/kg and endotracheal intubation. Maintenance will be as per institution protocol. Hemodynamic parameters, will be recorded at baseline, before the start of the study drug, 10 min after start of the study drug, after induction, during intubation, prior and after pneumoperitoneum and then every 15 min till the end of the surgery. After successful tracheal extubation, all patients will be transferred to PACU for further monitoring at predefined intervals. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA class I and II , scheduled For Elective Laparoscopic Gynecological surgeries like
Hysterectomy, Adnexectomy, Myoma enucleation, Diagnostic laparoscopy etc |
|
| ExclusionCriteria |
| Details |
Non consenting patient,
Malignant surgeries, BMI More Than 30 Kilogram Per Metre Square, Pregnant and Breastfeeding patients, history of chronic pain on analgesics and sedatives, significant or major comorbidities such as 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 or opioid addiction,
steroids, allergy to any medication, previous treatment with anti-platelet agents, antihypertensive
medication with clonidine or other beta 2 adrenergic agonist, and inability to comprehend postoperatively
the pain assessment scale and sedation scale. |
|
|
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 |
1.To compare the duration of post operative analgesia(defined as the time to first request for rescue analgesia following extubation, when VAS is more than four between the group receiving Dexmedetomidine 1 mcg/kg over 10 min before anesthesia induction followed by infusion at 0.3 mcg/kg/min after anesthesia induction and the group receiving 2% Lidocaine hydrochloride 1.5 mg/kg over 10 min before anesthesia induction followed by infusion at 1.5mg/kg/h after anesthesia induction
2.To evaluate the cumulative postoperative rescue analgesic consumption within the first 24 hours, after extubation. |
At Extubation
15 min
30 min
1 hr
2 hr
3 hr
4 hr
8 hr
12hr
24h |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Total intraoperative Inj. Fentanyl consumption in both the groups.
2.VAS scores measured at predefined intervals
3.Sedation levels measured using the Ramsay Sedation Score at predefined intervals
4.Intraoperative Hemodynamic instability requiring interventions for bradycardia, hypotension
and frequency of post operative side effects like PONV, shivering, bowel function |
15min
30 min
1 hr
2 hr
3 hr
4 hr
8 hr
12 hr,
24 hr post-extubation |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
All patients will be familiarised about 10-point Visual Analog Scale (VAS) during the preanesthetic visit.On the day of surgery, all ASA standard monitoring will be applied, and two 18 G intravenous cannula will be secured.Baseline parameters will be noted heart rate, Systolic blood pressure, Diastolic blood pressure,Mean arterial pressure SpO2, Bispectral index etc. Balanced salt solution will be connected inone of the 18 G intravenous cannula.All patients will be premedicated with intravenous glycopyrrolate 4 mcg/Kg. Study drug bolus infusion over 10 min will be started as per group allocation (Group D or Group L). After this initial bolus infusion, general anesthesia will then be instituted with Inj.Ketamine 0.5mg/Kg, Inj.Propool 1.5-2 mg/Kg till the loss of verbal command is commenced, Inj.Rouronium 0.6 mg/Kg intravenous and endotracheal intubation will be performed after 3 min.Afterwards maintenance dose of the study drug and Inj.Ketamine infusion of 0.25 mg/Kg/hr will be started. General anesthesia will be maintained with oxygen/air/sevoflurane mixture, intermittent boluses of Inj.Rocuronium to maintain Bispectral index of 40-60.Pre-emptive intravenous Diclofenac 75 mg, Inj.Dexamethasone 0.1mg/Kg will be administered post intubation. Hemodynamic parameters,BIS, will be recorded at baseline, before the start of study infusion drugs,10 min after starting the infusion of study drug, immediately after induction, during laryngoscopy and tracheal intubation, immediately prior and after pneumoperitonium creation, and then every 15 min,till the end of surgery.As per the standard protocol Intra operative management include treating hypotension and bradycardia with appropriate and total intra operative fentanyl requirements will be noted.Infusions of the study drug and ketamine will be discontinued upon release of pneumoperitonium and trocar removal and Inj.Ondanstron 4 mg, Inj.Paracetamol 1 gm will be given and continued every 8th hourly afterwards.Residual neuromuscular blockade will be reversed following completion of surgery.After successful tracheal extubation , patients will be transferred to PACU for further monitoring. The time from skin incision to completion of skin closure will be noted and the duration of surgery will be calculated in minutes. The total duration of anesthesia from the time of commencement of infusion of study drugs till tracheal extubation will also be calculated in minutes.Time from stoppage of infusions and tracheal extubation will be noted in minutes. |