| CTRI Number |
CTRI/2024/06/069691 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| 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
|
Comparison of Ketamine, Lidocaine and Dexmedetomidine Regimen compared to opioid based general anaesthesia in Laparotomy Surgeries. |
|
Scientific Title of Study
|
Efficacy of KeLiDex Regimen Compared to Opioid -based General Anaesthesia in Laparotomy Surgeries: A Randomised, Single-blind Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kausiki Poddar |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences, Deoghar, Devipur,Jharkhand
Deoghar
JHARKHAND
814152
India |
| Phone |
7557885057 |
| Fax |
|
| Email |
kausiki1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences, Deoghar, Devipur, Jharkhand
Deoghar
JHARKHAND
814152
India |
| Phone |
7063956225 |
| Fax |
|
| Email |
drsanjayaiims2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Kumar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences, Deoghar, Devipur, Jharkhand
Deoghar
JHARKHAND
814152
India |
| Phone |
7063956225 |
| Fax |
|
| Email |
drsanjayaiims2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Deoghar, Devipur, Deoghar, Jharkhand. PIN-814152, Country- India. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences, Deoghar, Devipur, Deoghar, Jharkhand, India. PIN- 814152 |
| Type of Sponsor |
Government 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 |
| Dr Kausiki Poddar |
All India Institute of Medical Sciences, Deoghar |
Operation theatre complex, Department of Anaesthesiology, All India Institute of Medical Sciences, Deoghar, Devipur. Deoghar, Jharkhand. PIN-814152
Deoghar
JHARKHAND |
7557885057
kausiki1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC OF ALL INDIA INSTITUTE OF MEDICALSCIENCES DEOGHAR |
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 |
Fentanyl |
Fentanyl 2mcg/kg in 10 ml volume as a bolus followed by 0.5 mcg/kg/hr infusion. Maintenace infusion will be started after Laryngoscopy and Endotracheal tube intubation.
Duration - The maintenance infusion will be continued till closure of abdomen and stopped once the rectus sheath has been closed. |
| Intervention |
KeLiDex: Ketamine, Lignocaine and Dexmedetomidine |
Loading dose of Ketamine-0.5mg/kg and Lignocaine- 1 mg/kg in 10 ml volume syringes. The bolus syringes will be coded and kept in the same tray as other induction and maintenance drugs prepared for GA. Further Ketamine 0.1mg/kg/hr+ Dexmedetomidine 0.2 mg/kg/hr and Lignocaine 0.25 mg/kg/hr will be administered as infusion during maintenance.
Duration - The maintenance infusions will be continued till closure of abdomen and stopped once the rectus sheath has been closed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Body mass index: 18.5-29.99 kg/m2.
Elective Laparotomy surgeries.
American Society of Anesthesiologists physical status (ASA-PS) I and II. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Patients with a diagnosis of shock and sepsis. Patients with severe organ failure requiring support like Respiratory, Liver, Cardiac, Renal.
Patients with uncontrolled hypertension greater than 150/90 mmHg.
Patients with suspected or known autonomic
neuropathy.
A special group of participants.
Preoperative bradycardia or Atrioventricular block
Intraoperative circumstances like vasopressor or
vasodilation infusion, if required or requiring
hypotensive anesthesia, and airway management
requiring unconventional techniques and modification of induction and oxygenation.
Laryngoscopy and endotracheal intubation time greater than 30 seconds. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare intraoperative hemodynamic variations (as a surrogate of adequate analgesia under controlled anaesthetic depth ) between the groups.
Parameters- Heart rate, blood pressure, respiratory rate, oxygen saturation
|
5 minutes before laryngoscopy, immediately after intubation, 5 minutes and 10 minutes after intubation, at the time of incision and 15 minutes thereafter. Vitals will be again noted just before and at 5 minutes post injection of reversal.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of tearing during laryngoscopy and intubation. |
At the time of laryngoscopy and endotracheal tube intubation. |
To compare the post extubation seadtion and discharge readiness from Post Anaesthetic care unit.
Parameters- time to reach Modified Aldrete Score, Richmond Agitation Sedation Scale, Likert scale for Post operative Nausea and Vomiting. |
Modified Aldrete Score measured every 5 minutes till it reaches a score of greater than or equal to 9 out of 10.
Richmond Agitation Sedation Scale will be noted at 5 minutes, 10 minutes, 30 minutes, 60 minutes, 120 minutes, 6 hours, 12 hours, 24 hours after extubation. |
| To compare postoperative 24-hour pain and rescue analgesics consumption. |
Numeric Rating Scale at rest and on movement at 10 minutes, 30 minutes, 60 minutes, 120 minutes, 6 hours, 12 hours and 24 hours in the postoperative period.
Time and dose of epidural top ups in the intraoperative and postoperative period. |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
08/07/2024 |
| 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
|
Participants in the study will undergo General anaesthesia and with Epidural catheter in situ for rescue analgesia. The intervention group will receive loading dose of Ketamine 0.5mg/kg and Lignocaine 1mg/kg in 10 ml syringes which is followed by ketamine 0.1 mg/kg/hr +dexmedetomidine 0.2mcg/kg/hr and Lignocaine 0.25 mg/kg/hr will be given as infusion during maintenance. The comparator group will receive fentanyl 2 mcg/kg in 10 ml volume as bolus followed by 0.5mcg/kg/hr infusion. Other general anaesthesia drugs like propofol used as per titrated to effect and vecuronium (loading dose 0.1 mg/kg, maintenance dose guided by Neuromuscular transmission monitoring. Epidural bolus given with 10 ml 0.2% ropivacaine in 2*5ml aliquots, 5minutes apart if Numeric Rating scale greater than 4 out of 10. Both groups receive low flow anaesthesia with Sevoflurane 3% OR isoflurane 1.5% for induction using Air+ oxygen titrated to MACage 1.1+/-0.1. All patients also receive paracetamol 15 ml/kg, maximum of 1 gm. This study is being done to find efficacy of non-opioid general anaesthesia in intervention versus opioid general anaesthesia in comparator group. |