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CTRI Number  CTRI/2019/11/022120 [Registered on: 22/11/2019] Trial Registered Prospectively
Last Modified On: 04/01/2022
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   Low-dose ketamine infusion during laparoscopic surgery for postoperative pain relief 
Scientific Title of Study   Intraoperative low dose ketamine infusion for postoperative pain relief in laparoscopic surgeries – A Prospective Randomised Double Blind Clinical Trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sujil Sudhersan 
Designation  Post Graduate 
Affiliation  Pondicherry Institute Of Medical Sciences 
Address  Room no. 101, annex PG hostel, Pondicherry Institute Of Medical Sciences, Ganapathychettikulam,Kalapet, Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9629847356  
Fax    
Email  sujilegwu25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mamie Zachariah 
Designation  Professor in Anaesthesiology 
Affiliation  Pondicherry Institute Of Medical Sciences 
Address  Department of Anaesthesiology. Pondicherry Institute Of Medical Sciences, Ganapathychettikulam,Kalapet, Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  8344252595  
Fax    
Email  mamiezac@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mamie Zachariah 
Designation  Professor in Anaesthesiology 
Affiliation  Pondicherry Institute Of Medical Sciences 
Address  Department of Anaesthesiology. Pondicherry Institute Of Medical Sciences, Ganapathychettikulam,Kalapet, Pondicherry

Pondicherry
PONDICHERRY
605014
India 
Phone  8344252595  
Fax    
Email  mamiezac@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute Of Medical Sciences, Ganapathychettikulam, Kalapet, Pondicherry. 605014  
 
Primary Sponsor  
Name  Pondicherry Institute Of Medical Sciences 
Address  Pondicherry Institute Of Medical Sciences, Ganapathychettikulam,Kalapet, Puducherry -605014 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujil Sudhersan  Pondicherry Institute Of Medical Sciences  Department of Anaesthesiology, Pondicherry Institute Of Medical Sciences, Ganapathychettikulam,Kalapet, Pondicherry- 605014.
Pondicherry
PONDICHERRY 
9629847356

sujilegwu25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.9% of normal saline infusion in patients undergoing laparoscopic surgery for postoperative pain relief.  0.9% of normal saline is given intravenously, a dose of 0.2mg/kg bolus before the first incision in surgery , followed by 0.1mg/kg/hour infusion till the end of surgery.Postoperatively the intensity of pain will be assessed.. 
Intervention  Low dose ketamine infusion in patients undergoing laparoscopy surgery for postoperative pain relief.  Ketamine is given intravenously, a dose of 0.2mg/kg bolus before the first incision in surgery , followed by 0.1mg/kg/hour infusion till the end of surgery.Postoperatively the intensity of pain will be assessed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  General surgical patients aged 18 to 60 years belonging to American society of anaesthesia (ASA) I and II posted for laparoscopic surgeries. 
 
ExclusionCriteria 
Details  1.Patients on chronic analgesic medication
2.Any known contraindication to the study drug
3.Patients with BMI> 30 kg/m2
4.Uncontrolled hypertension, raised intraocular pressure/glaucoma
5.Emergency surgery
6.Psychiatric patients
7.Pregnant women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Determination of the efficacy of low dose Ketamine for postoperative pain relief in laparoscopic surgeries.  6 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To study and compare the frequency and amount of opioid requirement postoperatively between the two groups.  6 hours 
To study and compare haemodynamic parameters intraoperatively between the two groups.

 
6 hours 
To study the occurrence of complications like hallucinations, sedation, vomiting, if any postoperatively.

 
6 hours 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   29/11/2019 
Date of Study Completion (India) 04/03/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

       1.     Title of the dissertation: Intraoperative low dose ketamine infusion for postoperative pain relief in laparoscopic surgeries – A Prospective Randomised Double Blind Clinical Trial.

 2.     Introduction:

               Patients who undergo laparoscopic surgery experience less pain, less scarring, early ambulation and short recovery in comparison to the traditional open abdominal surgeries. However, there are undesirable side effects like postoperative pain, especially in the abdomen, back and shoulder tip due to stretching of intra-abdominal cavity leading to stimulation of sympathetic nerves and also because of hypercarbia and irritation of the phrenic nerve by residual carbon dioxide in the peritoneum. It is reported that 50% to 70% of laparoscopic surgery patients experience moderate to severe postoperative pain.

             N- Methyl D Aspartate receptor activation is considered to be one of the reasons for postoperative pain through both central and peripheral effects. Ketamine, a phencyclidine derivative is a non-competitive NMDA receptor antagonist that produces dissociative anaesthesia and ketamine induced analgesia.

              In most published studies, ketamine has been used in varying doses for postoperative pain relief in laparoscopic surgeries. However, it is seen that the psychosensory side effects of ketamine increases at doses above 0.3 mg/kg and low doses less than or equal to 0.1mg/kg were found to be prophylactically ineffective.

             Ketamine has been used both as a single preemptive bolus dose as well as repeated bolus doses throughout the period of surgery for postoperative pain relief. Literature search did not reveal many studies that had used ketamine as continuous infusion intraoperatively. So we aim to study a low dose ketamine bolus followed by infusion throughout the period of surgery assuming the infusion of ketamine would maintain a steady state plasma concentration and thus provide a better postoperative pain relief. In addition to analgesic benefits of ketamine, it has also been found to reduce opioid consumption postoperatively thus resulting in reduced incidence of sedation and nausea vomiting in these patients.

                3.     Research hypothesis:  

                    Intraoperative low dose ketamine bolus followed by infusion  is effective in  reducing  postoperative pain in laparoscopic surgeries. 

                4.   Study procedure:

                 After obtaining ethical committee clearance of Pondicherry institute of medical sciences and informed as well as written consent ,52 patients aged 18-60 years  belonging to ASA I or ASA II will be enrolled in the study .A thorough pre-anaesthetic check up including detailed history, general and systemic examination and review of routine investigations will be conducted a day before surgery. All the patients will be shown the Numerical Rating Scale (NRS) preoperatively and instructed about its use as a tool for measuring and grading postoperative pain after ensuring nil per oral for a period of 8 hours. The selected patients will be split into two groups. One group will receive 0.2mg / kg ketamine bolus and then 0.1mg / kg / hour ketamine infusion until end of surgery. The other group will receive a similar amount of 0.9% NaCl. In the Operation Theater blood pressure, heart rate and oxygen levels will be monitored and recorded. An I V cannula will be secured for injecting medication. A face mask will be placed for the oxygen supply. After that they will be anaesthetized. Once unconscious, a tube is placed through the mouth . The air entry will be checked. Subsequently, the drug prepared will be provided under  supervision until the end of surgery. After surgery all the anaesthetic agents will be cut, oxygen will be given and the tube will be removed. After regain of consciousness, patients will be transferred to the recovery room , they will be questioned if there is pain or any side effects of the study drug, and will be evaluated according to the pain criteria explained  before the day of surgery. If there is pain after surgery, analgesics will be given. 

                5.  Parameters to be studied

a)     Postoperative pain

b)     Haemodynamic parameters

c)     Postoperative opioid consumption

d)     Grade of sedation

e)     Record of adverse effects if any.

               6.   Expected Outcome:

Determination of the efficacy of low dose Ketamine for postoperative pain relief in laparoscopic surgeries.

 
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