| CTRI Number |
CTRI/2025/07/091974 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of intraoperative antinociception efficacy with opioid vs opioid free anaesthesia. |
|
Scientific Title of Study
|
Comparative evaluation of Intraoperative antinociception efficacy with opioid (Fentanyl) vs opioid free anaesthesia (ketorolac, dexmedetomidine and ketamine) in patients undergoing Laparsocopic Cholecystectomy |
| 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 Sameera Khan |
| Designation |
PG 1ST Year Resident Doctor |
| Affiliation |
School of Medical Sciences and Research, Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and Research,Sharda University,plot no 32, knowledge park 3 ,Greater Noida ,Gautam Buddha Nagar, UTTAR PRADESH, INDIA
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
9560485736 |
| Fax |
0120-2323712 |
| Email |
sameera.khan@sharda.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Uttam Chandra Verma |
| Designation |
Head of Department |
| Affiliation |
School of Medical Sciences and Research, Sharda University |
| Address |
School of Medical Sciences and Research,Sharda University, plot no 32 , knowledge park 3,Greater Noida, Uttar Pradesh
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
9968604211 |
| Fax |
|
| Email |
uttam.verma@sharda.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Uttam Chandra Verma |
| Designation |
Head of Department |
| Affiliation |
School of Medical Sciences and Research, Sharda University |
| Address |
School of Medical Sciences and Research,Sharda University, plot no 32 , knowledge park 3,Greater Noida, Uttar Pradesh
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
9968604211 |
| Fax |
|
| Email |
uttam.verma@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Sharda Hospital ,Sharda University, Knowledge park 3 , Greater Noida |
|
|
Primary Sponsor
|
| Name |
SHARDA HOSPITAL |
| Address |
Department of Anaesthesia,Sharda Hospital,School of Medical Sciences and Research, Sharda University, Knowledge Park 3, Greater Noida |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sameera Khan |
Department of Anaesthesia ,Sharda Hospital |
School of Medical Sciences and Research,Sharda University,Knowledge Park 3 Greater Noida, Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH |
09560485736
sameera.khan@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (3) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comparative evaluation of antinociception efficacy of opioid vs opioid free anaesthesia |
Comparison of opioid (fentanyl) vs opioid free anaesthesia (ketamine, dexmedetomidine, ketorolac) in patients undergoing Laparoscopic Cholecystectomy |
| Comparator Agent |
Patients of group F will receive an iv bolus of inj fentanyl 2 mcg/kg.After 10 min infusion of fentanyl started at rate of 1 mcg//kg/hr.Patients of group KDK will receive an iv bolus of inj ketorolac 30 mg iv , inj ketamine 0..3 mg/kg, inj dexmedetomidine 0.5 mcg/kg. |
Patients of group F will receive an iv bolus of inj Fentanyl 2mcg/kg. After 10 min infusion of fentanyl started at rate of 1mcg/kg/hr.A repeat dose of inj Fentanyl 10 mcg iv bolus will be given if SPI exceeds 50.
Patients of group KDK will receive an iv bolus of inj ketorolac 30 mg iv, inj ketamine 0.3 mg/kg, inj dexmedetomidine 0.5 mcg/kg.A repeat dose of inj ketamine 0.2 mg/kg iv bolus will be administered if the SPI exceeds 50.Infusion of dexmedetomidine 0.2 mcg/kg will be continued till the end of skin closure.
Both the groups will be induced with inj propofol at 2mg/kg iv bolus and cis atracurium 0.2 g/kg to facilitate intubation followed by continuous infusion of inj propofol at 10 mg/kg/hr for first 10 min , 8mg/kg/hr for next 10 min , and 6 mg //kg/hr subsequently to maintain SE/RE in the range of 40-60 till the end of surgery. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient scheduled for Laparoscopic cholecystectomy
2.Age 18-60 years
3.ASA grade 1 and 2
4.Both genders
5.Duration of surgery less than 2 hours |
|
| ExclusionCriteria |
| Details |
BMI more than 30 kg per meter square
History of CNS, vascular, renal and respiratory diseases
History of endocrine disease-diabetes mellitus and thyroid disease
History of psychiatric illness
Pregnant females
History of usage of opioids and any other analgesics
Patient having history of drug allergy to ketamine, ketorolac and
dexmedetomidine
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the intraoperative anti nociception efficacy with opioid vs opioid free anaethesia (ketamine, dexmedetomidine, ketorolac) by change in SPI in response to surgical noxious stimulation following skin incision |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare the intraoperative anti-nociception efficacy with opioid (fentanyl) vs opioid free anaesthesia (Ketamine, Dexmedetomidine and Ketorolac) with regard to: -
a) SPI
b) HR, MAP, Lacrimation, sweating
|
24 hrs |
2) To evaluate and compare the intraoperative anti-nociception efficacy with opioid (fentanyl) vs opioid free anaesthesia (Ketamine, Dexmedetomidine and Ketorolac) with regard to: - a) Duration of Postoperative analgesia and pain severity
b)Duration of Postoperative Nausea and Vomiting
c)Duration of discharge from Post Anaesthetic Care Unit
d)Post operative assessment of awareness
e)Total consumption of propofol, fentanyl, cis-atracurium, ketamine, Dexmedetomidine and Ketorolac.
|
24 hrs |
|
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Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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)
|
10/08/2025 |
| 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)
|
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
|
Nociception
refers to the unconscious detection of a noxious stimulus caused by trauma or
surgical intervention, which is manifested through responses of the autonomic
nervous system. Providing anti-nociception is one of the primary
functions of general anaesthesia during surgical procedure. Opioid-Free
Anaesthesia (OFA) is a developing technique and a growing focus in recent
research, founded on the concept that eliminating intraoperative opioid use may
lead to improved postoperative outcomes.
Opioid-free
anaesthesia refers to the complete avoidance of opioids during the
preoperative, intraoperative, and recovery phases. Despite their continued role
as a key component in general anaesthesia for managing pain during and after
surgery, opioids are linked to a range of side effects including drowsiness,
dizziness, constipation, nausea, vomiting, respiratory depression, pruritus,
and urinary retention. Additionally, two significant concerns associated with
opioid use are the development of hyperalgesia and opioid tolerance. Therefore,
it is important to investigate and assess novel non-opioid analgesic agents
following laparoscopic cholecystectomy as part of strategies aimed at reducing
opioid use. Dexmedetomidine, a centrally acting alpha-2 adrenoreceptor agonist,
shows considerable promise in enhancing analgesia and stabilizing hemodynamic
responses during endotracheal intubation and the creation of pneumoperitoneum.
Its perioperative analgesic effectiveness and sedative qualities have been
extensively explored across various major surgical procedures, yielding
encouraging outcomes. Dexmedetomidine’s potential role in
facilitating early recovery following day care surgeries has recently become a
topic of growing interest among anesthesiologists. Ketamine possesses strong
analgesic, amnesic, and opioid-sparing characteristics. When administered in
low doses (less than 0.5 mg/kg), it provides effective analgesia with minimal
adverse effects. A single administration of ketamine can
markedly decrease postoperative opioid requirements in day care procedures like
laparoscopic cholecystectomy. The
Surgical Pleth Index (SPI) serves as an objective measure to assess the balance
between nociception and anti-nociception, helping to guide intraoperative
analgesic administration. SPI values range from 0 to 100, with a recommended
target range of 20 to 50 during general anesthesia. An SPI value exceeding 50
for more than 3 to 5 minutes typically indicates excessive noxious stimulation,
suggesting the need for additional analgesic intervention.
Entropy
monitoring is an objective method consisting of two components—Response Entropy
(RE) and State Entropy (SE)—which reflect the levels of analgesia and hypnosis
during general anesthesia. Ketorolac
is a nonsteroidal anti-inflammatory drug that possesses significant analgesic
potency. It provides analgesia equivalent to commonly used doses of meperidine
and morphine. It has been used extensively in emergency departments for a
variety of painful conditions, frequently as a first-line drug.
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