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
|
|
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
|
|
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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