CTRI Number |
CTRI/2023/08/056869 [Registered on: 24/08/2023] Trial Registered Prospectively |
Last Modified On: |
22/08/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of opioid versus opioid free anaesthesia with ketamine and lidocaine on post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
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Scientific Title of Study
|
Comparative evaluation of opioid versus opioid free anaesthesia with ketamine and lidocaine on post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Varalika Sharma |
Designation |
Junior resident |
Affiliation |
Department of Anaesthesiology School of Medical Sciences and Research Sharda University |
Address |
Department of Anaesthesiology School of medical sciences and research Sharda University Knowledge park 3 plot no 32 34 Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9760331885 |
Fax |
|
Email |
dr.varalikasharma7623@gmail.com |
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Details of Contact Person Scientific Query
|
Name |
UC Verma |
Designation |
Proffessor |
Affiliation |
Department of Anaesthesiology School of Medical Sciences & Research Sharda University |
Address |
Department of Anaesthesiology School of medical sciences and research Knowledge park 3 plot no 32 34 Greater Noida Gautam Buddha Nagar UTTAR PRADESH 201310 India |
Phone |
9968604211 |
Fax |
|
Email |
uttam.verma@sharda.ac.in |
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Details of Contact Person Public Query
|
Name |
UC Verma |
Designation |
Proffessor |
Affiliation |
Department of Anaesthesiology School of Medical Sciences & Research Sharda University |
Address |
Department of Anaesthesiology School of medical sciences and research Knowledge park 3 plot no 32 34 Greater Noida
UTTAR PRADESH 201310 India |
Phone |
9968604211 |
Fax |
|
Email |
uttam.verma@sharda.ac.in |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology,school of medical sciences and research,sharda university |
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Primary Sponsor
|
Name |
school of medical sciences and research,sharda university |
Address |
Greater Noida, Gautam Budh Nagar-201306 (U.P)
|
Type of Sponsor |
Private medical college |
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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 |
Druttam chandra verma |
School of Medical Sciences and Research |
Department of Anaesthesiology,
second floor B block
Sharda University, School of Medical Sciences and Research,knowledge park 3,plot no 32,33,gautam budh nagar,greater noida Gautam Buddha Nagar UTTAR PRADESH |
9968604211
uttam.verma@sharda.ac.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, school of medical sciences and research, sharda university, greater noida |
Approved |
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Comparative evaluation of opioid versus opioid free anaesthesia with ketamine and lidocaine on post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy |
Comparative evaluation of opioid versus opioid free anaesthesia with ketamine and lidocaine on post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy |
Comparator Agent |
comparision between fentanyl and combination of ketamine and lidocaine |
Group F – Patients will receive fentanyl 2mcg/kg IV bolus at the time of induction and
normal saline infusion preparation till the end of surgery.
Group KL –– Patients will receive Inj. Ketamine 0.3mg/kg IV bolus at the time of induction
and Inj. Lidocaine 1.5mg/kg followed by 2mg/kg/hr. IV infusion till the end of surgery. |
Comparator Agent |
comparison of fentanyl with combination of ketamine and lidocaine |
Group F – Patients will receive fentanyl 2mcg/kg IV bolus at the time of induction and normal saline infusion preparation till the end of surgery.
Group KL –– Patients will receive Inj. Ketamine 0.3mg/kg IV bolus at the time of induction and Inj. Lidocaine 1.5mg/kg followed by 2mg/kg/hr. IV infusion till the end of surgery.
All the patients will be kept under supervision for 24 hours. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. ASA I and II
2. Age 18-60yrs
3. Both genders
4. Surgeries ≤ 2 hours
|
|
ExclusionCriteria |
Details |
1. BMI > 30 kg m¬-2
2. Pregnant females
3. Patients having history of motion sickness and migraine.
4. Patients having history of drug allergy to ketamine and lidocaine.
5. Patients having history of respiratory, cardiovascular, renal, hepatic and endocrine disease and psychosis.
 
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Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Double Blind Double Dummy |
Primary Outcome
|
Outcome |
TimePoints |
To compare the effect of fentanyl (opioid) versus ketamine & lidocaine (opioid free) anaesthesia on post-operative nausea and vomiting in laparoscopic cholecystectomy. |
Post operative 24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the effect of fentanyl (opioid) versus ketamine & lidocaine (opioid free) anaesthesia in laparoscopic cholecystectomy with regard to:
1. VAS Score for post-operative pain.
2. Duration of analgesia in post-operative period.
3. Sedation score postoperatively.
4. The duration of discharge from PACU.
|
24 hours |
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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 2 |
Date of First Enrollment (India)
|
10/09/2023 |
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)
|
Not Yet Recruiting |
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
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Brief Summary
|
Opioids are commonly used
for analgesia and supplementary sedation during general anaesthesia and are the
most widely used agents for the treatment of acute pain in the immediate
postoperative period. Opioids provide effective analgesia and stable
intraoperative hemodynamics, which are valuable during the perioperative
period. However, the use of opioids during the perioperative period is risky.
Opioids have many potential adverse effects, including respiratory depression,
postoperative nausea and vomiting (PONV), and opioid-induced hyperalgesia (OIH).
These complications are associated with delayed patient recovery, prolonged
stay in the post-anaesthetic care unit (PACU), delayed hospital discharge, and
unexpected hospitalization, all contributing to an increased burden on patients
and resources.Perioperative opioids
are administered for postoperative analgesia, and intra-operatively to control
the sympathetic response to surgical stimuli, frequently as a surrogate for presumed
pain.Opioid free anaesthesia (OFA) is a technique where the
intraoperative use of systemic, neuraxial or intracavitary opioid is completely
avoided. This new technique can provide intraoperative
hemodynamic stability, immobility and postoperative analgesia without
administering opioid drugs, and therefore the absence of the numerous side
effects caused by opioids.3Opioids are used in general
anaesthesia in various surgeries, though laparoscopic surgeries are considered
relatively less painful and are associated with early recovery and lesser
duration of hospital stay, they can cause severe pain, especially in four hours
of the immediate post-operative period. This may be attributed to the
peritoneal irritation caused by the carbon dioxide insufflation pressures,
bowel handling by the surgeons or irritation caused by the residual or retained
blood.4 Post-operative nausea and vomiting (PONV) are some of
the most common complications after anaesthesia, often reducing patient
satisfaction and prolonging the recovery and discharge from hospital. This is
defined as nausea or vomiting that occurs during first 24 hours to 48 hours
after surgery. Opioids can cause nausea and vomiting by stimulating the area
postrema at floor of fourth ventricle.5The risk of PONV in the
general surgical population is approximately 30%. In high-risk patient groups,
or high-risk surgical procedures, the risk of PONV can be as high as 80%. PONV
is a distressing experience for the patient and can have a significant impact
on patient satisfaction. PONV may prolong post-anaesthesia care unit (PACU)
stay and increase the risk of postoperative complications.6Lidocaine is an amide local
anaesthetic that has analgesic, antihyperalgesic and anti-inflammatory
properties. These properties of lidocaine are mediated by channel blockade,
inhibition of G protein coupled receptors and NMDA receptors.7In addition to improving
analgesia, perioperative lidocaine infusion shortens the duration of
postoperative ileus by an average of 8 hours, and decreases the incidence of
postoperative nausea and vomiting. 8 Ketamine, a phencyclidine derivative, an
N-methyl-d-aspartate antagonist, blunts central pain sensitization at sub
anaesthetic doses (0.3mg/kg or less). Ketamine has been increasingly used as an
adjunct in the management of acute postoperative pain. Ketamine can
inhibit the spread of nociceptive impulses to the brain. It can be administered
by multiple routes, including intravenous, bolus injection, continuous IV
infusion, epidural route and even wound infiltration. Ketamine is now preferred
drug in many procedures like sedation for MRI, premedication in children,
procedural sedation and acute and chronic pain management. Sub anaesthetic ketamine
improves pain scores and reduces perioperative opioid consumption in a broad
range of surgical procedures with a minimal risk of side effects. 9 Lacunae in the existing
knowledgeExtensive search of literature reveals that, it
has been found that no previous studies have observed the effect of ketamine and
lidocaine (OFA) on post-operative nausea and vomiting. Therefore, in this study
we will compare the effect of fentanyl (opioid)
versus opioid free anaesthesia with ketamine and lidocaine on post-operative
nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
|