| CTRI Number |
CTRI/2025/04/085618 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision Of Recovery Quality after giving Intravenous Lignocaine and Intravenous Fentanyl In Patients Undergoing Nasal Surgery Under General Anaesthesia |
|
Scientific Title of Study
|
A Comparative Prospective Randomised Double blind Study To Compare Of Quality Of Recovery QoR 15 Following Administration Of Intravenous Lignocaine Versus Fentanyl In Patients Undergoing Functional Endoscopic Sinus Surgery Under General Anaesthesia In SMS Medical College Jaipur |
| 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 Priyanka Jain |
| Designation |
Professor |
| Affiliation |
SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL |
| Address |
Department Of Anaesthesia
SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITAL
JAIPUR
RAJASTHAN
302004
INDIA
Jaipur
RAJASTHAN
302004
India |
| Phone |
9309482150 |
| Fax |
|
| Email |
priyanka.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Jain |
| Designation |
Professor |
| Affiliation |
SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL |
| Address |
Department Of Anaesthesia
SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL
Jaipur
RAJASTHAN
302004
INDIA
Jaipur
RAJASTHAN
302004
India |
| Phone |
9309482150 |
| Fax |
|
| Email |
aiims.priyanka@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Potharlanka Jeevana |
| Designation |
Resident Doctor |
| Affiliation |
SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL |
| Address |
Department Of Anaesthesia
SAWAI MAN SINGHMEDICAL COLLEGE AND ATTACHED HOSPITAL
JAIPUR
RAJASTHAN
302004
INDIA
Jaipur
RAJASTHAN
302004
India |
| Phone |
8500253219 |
| Fax |
|
| Email |
jeevanapotharlanka@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia
SMS MEDICAL COLLEGE AND ATTACHED HOSPITAL
JAIPUR
RAJASTHAN
302004
INDIA |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesia Sawai Man Singh Medical College And Attached Hospital Jaipur |
| Address |
Department Of Anaesthesia
SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITAL
JAIPUR
RAJASTHAN
302004
INDIA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Potharlanka Jeevana |
Charak Bhavan ENT OT second floor |
SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS
DEPARTMENT OF ANAESTHESIA
Jaipur
RAJASTHAN |
8500253219
jeevanapotharlanka@gmail.com |
| Dr Priyanka Jain |
Sawai Man Singh Medical College And Attached Hospital |
Department Of Anaesthesia
ENT Operation Theatre
CHARAK BHAVAN SECOND FLOOR
JAIPUR
RAJASTHAN
302004
Jaipur
RAJASTHAN |
9309482150
priyanka.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Fentanyl Group |
DOSE Bolus Of 2 microgram per kg followed by continuous infusion of 0.5 microgram per kg per hour
ROUTE OF ADMINISTRATION Intravenous
FREQUENCY OF ADMINISTRATION Single dose at induction followed by continuous infusion intraoperatively
TOTAL DURATION OF ADMINISTRATION Administered from induction of general anaesthesia and continued until end of surgery |
| Intervention |
Intravenous Lignocaine Group |
DOSE bolus of 1.5 mg per kg followed by infusion of 2 mg per kg hour
ROUTE OF ADMINISTRATION Intravenous
FREQUENCY OF ADMINISTRATION Single dose at induction followed by continuous infusion intraoperatively
TOTAL DURATION OF ADMINISTRATION Administered from induction of general anaethesia and continued until end of surgery
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Informed written consent
Age 18 to 60 years
Elective Functional Endoscopic Sinus Surgery under General anaesthesia
ASA GRADE I AND II |
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to local anaesthetics
Body mass index greater than 30kg/m2
Patients with clinically significant neurological psychiatric or cardiovascular or renal and hepatic diseases
History of alcoholic or drug abuse
Patients who received an opioid medication within a 24 hour period before surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Recovery score QoR 15 postoperatively |
At 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare the postoperative analgesia duration and total number of doses in 24 hours between the two study groups |
24hours |
| To assess Numercal rating scale score at various time intervals between the two study groups |
At 30mintes 6 hours 12 hours 24 hours |
| To compare the adverse effects between the two groups if any |
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="2"
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
|
This Prospective randomised controlled trial aims to compare the effects of Intravenous Lignocaine versus Intravenous Fentanyl on postoperative recovery qualit in patients undergoing Functional Endoscopic Sinus Surgery FESS Under General anaesthesia Both drugs are commonly used for I trapper active analgesia and modulation of peri operative stress responses
Sixty patients aged 18 to 60 years classified as ASA Physical status I or II scheduled for elective FESS will be randomly allocated into two groups Gruop L will receive intravenous lignocaine 1.5mg/ kg bolus followed by 2mg/kg/hour infusion and Group F will receive Intravenous fentanyl 2 mcg/kg bolus followed by 0.5 mcg/kg/hour infusion till end of surgery
The primary outcome will be the Quality of recovery QoR 15 score at 24 hours postoperatively Secondary outcomes include time to first rescue analgesia with total number of analgesic doses in 24 hours and to assess the Numerical Rating Scale Score at various time intervals between the two study groups and to compare the adverse effects such as nausea vomiting bradycardia hypotension between the two groups
This study seeks to determine whether lignocaine a non opioid analgesic with anti inflammatory and anti hyper Algeria properties can provide superior recovery outcomes compared to the conventional opioid Fentany in ENT surgeries |