| CTRI Number |
CTRI/2024/09/074353 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of use of different opioids in postoperative recovery in patients undergoing Laparoscopic Cholecystectomy. |
|
Scientific Title of Study
|
Comparison of use of Remifentanil versus Fentanyl in Postoperative Recovery in Patients undergoing Laparoscopic Cholecystectomy :A Quasi Experimental Study |
| 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.Pravin Kumar Das |
| Designation |
Professor Department of Anaesthesiology and Critical Care Medicine, Dr RMLIMS Lucknow. |
| Affiliation |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND,GOMTI NAGAR, LUCKNOW. |
| Address |
DR.RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, GOMTI NAGAR,LUCKNOW-226010
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9936565574 |
| Fax |
|
| Email |
drpkdasmadhubani@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DINESH KUMAR R |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND,GOMTI NAGAR, LUCKNOW. |
| Address |
DR.RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, GOMTI NAGAR, LUCKNOW-226010
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8667481143 |
| Fax |
|
| Email |
dinesh01021997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRDINESH KUMAR R |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND,GOMTI NAGAR, LUCKNOW. |
| Address |
DR.RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, GOMTI NAGAR, LUCKNOW-226010
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8667481143 |
| Fax |
|
| Email |
dinesh01021997@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES GOMTI NAGAR, LUCKNOW-226010 |
|
|
Primary Sponsor
|
| Name |
DrDinesh kumar |
| Address |
DR.RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, GOMTI NAGAR, LUCKNOW-226010 |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| DRDINESH KUMAR R |
DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND,GOMTI NAGAR, LUCKNOW, PIN CODE 226010. |
PAC CLINIC OPD NUMBER 11,GASTROSURGERY OT 1ST FLOOR,COMBINED HOSPITAL OT OLD BUILDING.
Lucknow
UTTAR PRADESH |
8667481143
dineshk01021997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR.RITU KAROLI, CO MEMBER, SECRETARY INSTITUTIONAL ETHICS COMMITTEE, DR RMLIMS LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
POST OPERATIVE RECOVERY PROFILE Opiod Analgesic agent:FENTANYL |
Group F: (Patients with BMI (Body Mass Index) less than or equal to 24.9 kg/m2).
Patients receiving inj. Fentanyl bolus I/V (2 mcg/kg) during induction and intermittent bolus of 25 to 50 mcg at certain phases of Painful surgical stimulus |
| Comparator Agent |
POST OPERATIVE RECOVERY PROFILE using Opiod Analgesic agent:REMIFENTANIL |
Group R (Patients with BMI (Body Mass Index) greater than or equal to 25 kg/m2).
Patients receiving inj. Remifentanil bolus I/V (0.2 mcg/kg) and followed by IV infusion (0.05 to 0.5 mcg/kgmin) till the skin closure. . |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients giving written informed consent
2.Adult ASA I and Il patients aged 20 to 60 years undergoing elective Laparoscopic cholecystectomy
3.Group R (Patients with BMI (Body Mass Index) greater than or equal to 25 kg/m2) #1
4.Group F: (Patients with BMI (Body Mass Index) less than or equal to 24.9 kg/m2) #1 |
|
| ExclusionCriteria |
| Details |
Neurological Deficit
Renal Failure
Chronic liver disease
H/o Drug abuse: (opioid, Alcohol)
Patients on Anticonvulsants medication Psychiatric disorder
Any Cardiac disease ( ischemic,Valvular, Rhythm disorder) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the Quality of recovery in the post operative period following General Anesthesia with I/V Remifentanil and Fentanyl infusion in patients undergoing Laparoscopic Cholecystectomy |
Pre Procedure, 4,6 and 8 hours post Procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Evaluate MODIFIED ALDRETE SCORE at 4 ,6 & 8 heurs ost extubation.
To Evaluate Post Operative Analgesic consumption.
To Evaluate the Post Operative Visual Analog Scale (VAS) for pain at 4.6 & 8 hours post extubation.
To note any side eflects related to study drugs, |
To Evaluate MODIFIED ALDRETE SCORE at 4 ,6 & 8 heurs ost extubation.
To Evaluate Post Operative Analgesic consumption.
@ 4,6,8 hours post Procedure.
To Evaluate the Post Operative Visual Analog Scale (VAS) for pain at 4.6 & 8 hours post extubation.
To note any side eflects related to study drugs, |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
01/11/2024 |
| 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
|
Prolonged and inadequate recovery post surgery has always been a matter of concern for anesthesiologist and there has always been a continued search for drugs with short duration of action imparting early recovery post anesthesia. Fentanyl (synthetic morphine analogue) an opioid, had been a popular option for post operative pain management. Its potency and duration of action can be advantageous in maintaining stable analgesia but when used for extended period, the risk of respiratory depression and delayed recovery remains there as it has prolonged context sensitive half life. Remifentanil (4-anilidopiperadine), came to the clinical practice in the year 1996, for the use in the induction and maintenance of general anesthesia. its short half-life (8 -10 minute) and quick onset of action( 1 minute) allow for titrated management of analgesia while reducing the possibility of respiratory depression due to ultra short context sensitive half time( 3-4 minute). Laparoscopic Cholecystectomy is a common surgical procedure associated with moderate to severe postoperative pain, adversely affecting patient satisfaction as well as recovery. Understanding these subtle differences can personalize opioid sclection and optimize patient exxperiences. The choice between remifentanil and fentanyl infusion in postoperative recovery depends on various factors like individual patient characteristics, |