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CTRI Number  CTRI/2021/01/030301 [Registered on: 07/01/2021] Trial Registered Prospectively
Last Modified On: 06/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Post operative pain comparison in patients undergoing elective laparoscopic surgery who is receving fentanyl and the patients who is receiving dexmedetomidine 
Scientific Title of Study   Comparison of opioid free versus opioid based anaesthesia on postoperative pain intensity for laparoscopic surgeries, a randomised prospective double blinded study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Katta Venkata Naveen 
Designation  POSTGRADUATE 
Affiliation  JSS medical college and hospital, mysuru 
Address  Department of Anaesthesiology , jss hospital , mysore , karnataka , 570004 , india

Mysore
KARNATAKA
57004
India 
Phone  9160992667  
Fax    
Email  naveen.katta77@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr GURUDATT C L  
Designation  Professor and Head of Department of Anaesthesiology 
Affiliation  jss medical college and hospital, mysuru 
Address  Dr GURUDATT C L, Professor and Head of Department of Anaesthesiology, MG road, Agrahara, Mysore

Mysore
KARNATAKA
57004
India 
Phone  9845312311  
Fax    
Email  dattguru55@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr GURUDATT C L 
Designation  Professor and Head of Department of Anaesthesiology 
Affiliation  jss medical college and hospital, mysuru 
Address  Dr GURUDATT C L, Professor and Head of Department of Anaesthesiology, MG road, Agrahara, Mysore

Mysore
KARNATAKA
57004
India 
Phone  9845312311  
Fax    
Email  dattguru55@gmail.com  
 
Source of Monetary or Material Support  
JSS MEDICAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  JSS MEDICAL COLLEGE AND HOSPITAL 
Address  JSS MEDICAK COLLEGE AND HOSPITAL, MG ROAD , MYSORE 
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 KATTA VENKATA NAVEEN  JSS MEDIACL COLLEGE ANAD HOSPITAL  Patients of general surgery and gynaecology , posted for elective laparoscopic surgery, ot complex , 3rd floor and 2nd floor ot complex , theatre 3, MG Road , Aghrahara , Mysore
Mysore
KARNATAKA 
9160992667

naveen.katta77@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETICAL COMMITEE, JSS MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (3) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (4) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (5) ICD-10 Condition: K810||Acute cholecystitis, (6) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle, (7) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, (8) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, (9) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (10) ICD-10 Condition: N921||Excessive and frequent menstruation with irregular cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj Fentayl , 100ml NS plain  100 ml NS over 10-15 minutes before induction along with Inj Fentanyl 1mcg/kg diluted to 2ml to patients posted for elective laparascopic surgery  
Intervention  DEXMEDETOMIDINE, KETAMINE  Inj Dexmedetomidine infusion 1mcg/kg/body weight diluted to 100ml NS over 10-15 minutes before induction along with Inj Ketamine 25mg to patients posted for elective laparoscopic surgery 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA physical status class 1 and 2 aged 20-60 years undergoing elective laparoscopic surgeries lasting for <2 hours 
 
ExclusionCriteria 
Details  Pregnant, breast feeding women, hepatic, renal or cardiac insufficiency, psychiatric disease, allergy or contraindicated to study drugs, BMI >30, Obstructive sleep apnoea syndrome.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Amount of post-operative pain intensity in terms of visual analogue score (VAS) and rescue analgesics requirements  starting of general anaesthesia till twenty four hours after completion of surgery.  
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of intraoperative haemodynamic stability.
2. Post-operative recovery status.
3. Post-operative sedation in terms of Ramsay-sedation scoring system.
4. Incidence of post-operative nausea and vomiting.
 
starting of general anaesthesia till twenty four hours after completion of surgery.  
 
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   N/A 
Date of First Enrollment (India)   07/01/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Following approval from institutional ethical committee, informed consent and written consent will be taken from 70 patients of American Society of Anaesthesiologist (ASA) physical status class I/II undergoing laparoscopic surgeries under general anaesthesia.

Patients will be randomly allocated into 2 groups;

Group 1- DK group

Receiving Dexmedetomidine 1mcg/kg/body weight& ketamine 25mg intravenously.

Group 2- F group

Receiving Fentanyl 1mcg/kg/body weight intravenously.

Randomization will be done by another anaesthesiologist (who will not take part further in the study) using shuffled sealed envelope technique.

All the patients are evaluated on the previous day of surgery& on the morning of the surgery. Patients are shifted to operation theatre and connected with multi parameter monitor (PHILIPS intellivue MP-20) and baseline parameters like systolic blood pressure(SBP); diastolic blood pressure (DBP);mean arterial pressure(MAP) &heart rate (HR), saturation of O2 will be noted.

    Patients belonging to DK group will receive Inj Dexmeditomidine 1mcg/kg diluted to100ml NS and infused over 10-15min before induction. Inj. Ketamine 25mg diluted to 2ml with NS will be injected before induction.

     Patients belongs to F group will receive 100 ml of NS over 10-15 min before induction and Inj Fentanyl 1mcg/kg diluted to 2 ml will be administrated iv before induction.

     The study drugs will be prepared by the same anaesthesiologist involved with randomization who will not take part further in the study and thus the observer and patient will be blinded to study.

      All the patients will be given 1.5mg/kg/body weight of IV lidocaine(preservative free) after pre-oxygenation for 3min, followed by 1% propofol till the loss of eye lash reflexes and total dose of propofol used will be noted.

All the patients will be intubated with appropriate sized ET tubes using 0.1mg/kg of vecuronium. Patients will be maintained using O2+ N2O (30:70) and isoflurane 0.5%. Intraoperative blood pressure (BP) and heart rate (HR) will be monitored and any increase of either BP or HR more than 20% of baseline will be managed by increasing the isoflurane to 1% and if not controlled additional boluses of 20mg of propofol will be given and number of doses of propofol will be noted. Any fall in SBP more than 30% will be treated with IV fluids and if required 6mg of ephedrine boluses & number of doses of ephedrine will be noted. Any decrease in heart rate less than 50/min will be treated with Inj. Atropine 0.6mg. Patients will be given Inj. Dexamethasone 8mg after induction and Inj. Ondansetron 4mg just before extubation. Patients are administered with inj. Paracetamol 1gm IV and Inj. Diclofenac 75mg iv intraoperatively. At end of surgery patients will be reversed with 0.05mg/kg Inj  Neostigmine and Inj Glycopyrolate 0.01mg/kg.

     Time of recovery will be noted from the time of administrating reversal drugs and patients satisfying the extubation criteria are extubated. All the patients are shifted to post anaesthetic care unit (PACU) and monitored for post-operative pain using VAS score at the interval of immediate post- operative and 2nd  hourly for 6 hours and every 6th hourly for 24 hours. Any patient with VAS score >4 will receive rescue analgesic Inj. Diclofenac 75mg and number of doses in 24 hours will be noted.

     Incidence of post-operative nausea and vomiting will be noted every 2nd hourly up to 6 hours and every 6th hourly up to 24 hours. Incidence of post-operative nausea and vomiting (PONV) will be treated with Inj. Ondansetron 4mg and the number of injections will be noted.

    The post-operative sedation will be noted based on Ramsay sedation score immediately after extubation.

Ramsay sedation score:

  Score          Definition

1              Anxious and restless or agitated or both.

2              Co-operative, oriented and tranquil.

3              Responds to commands only.

4              Brisk response to a light glabellar tap or loud auditory stimulus.

5              Slight response to a light glabellar tap or loud auditory stimulus.

6              No response to a light glabellar tap or loud auditory stimulus.

 

 
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