| CTRI Number |
CTRI/2025/03/083134 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the quality of recovery score between fentanyl and lignocaine in septoplasty surgeries |
|
Scientific Title of Study
|
Comparison of Quality of Recovery (QoR-15)following the administration of intravenous lignocaine infusion and intravenous fentanyl infusion in patients undergoing septoplasty under general anaesthesia A double-blinded, randomized, controlled trial |
| 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. Ramya Rao M |
| Designation |
Resident |
| Affiliation |
Sri Ramachandra Institute of Higher Education And Research |
| Address |
Department of Anaesthesiology, Sri Ramachandra Medical College, Sri Ramachandra University, Porur, Chennai 600116 Tamil Nadu India
Chennai
TAMIL NADU
600116
India |
| Phone |
9789802319 |
| Fax |
|
| Email |
drrao.306@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jayaraman |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Sri Ramachandra Institute of Higher Education And Research |
| Address |
Department of Anaesthesiology, Sri Ramachandra Medical College, Sri Ramachandra University,
Porur, Chennai 600116 Tamil Nadu India
Chennai
TAMIL NADU
600116
India |
| Phone |
9841219820 |
| Fax |
|
| Email |
vjram2001@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR JAYARAMAN |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Department of Anaesthesiology, Sri Ramachandra Medical College, Sri Ramachandra University,
Porur, Chennai 600116 Tamil Nadu India
TAMIL NADU
600116
India |
| Phone |
9841219820 |
| Fax |
|
| Email |
vjram2001@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education and Research, Porur, chennai 600116 Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Sri Ramachandra University Porur Chennai 600116 Tamil Nadu |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ramya Rao M |
Sri Ramachandra Institute Of Higher Education And Research |
Department of Anaesthesiology, Sri Ramachandra Institute Of Higher Education And Research, Porur Chennai 600116 Tamil Nadu
Chennai
TAMIL NADU |
9789802319
drrao.306@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J342||Deviated nasal septum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
2 microgram per kg bolus followed by 0.5 microgram per kg per hour infusion till the end of the surgery |
| Intervention |
Lignocaine |
iv lignocaine 1.5 mg per kg bolus followed by 2 mg per kg per hour infusion till the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical status 1 and 2
Scheduled for septoplasty |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to local anestetic
Alcohol or drug abuse
Body mass index more than 30
psychiatric cardiovascular renal and hepatic disease
patients who have received an opioid within 24 hours befor surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of recovery score |
1 hour prior to surgery
24 hours after surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
POST OPERATIVE ANALGESIA
POST OPERATIVE NRS SCORE
RECOVERY CHARACTERISTICS
ADVERSE EFFECTS OF LIGNOCAIN AND FENTANYL
DELAYED EMERGENCE
NUMBER OF RESCUE MEDICATIONS NEEDED |
NSR SCORE at 5 minutes, 30 minutes, 1 hour, 2 hours,4 hours, 8 hours, 12 hours, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="1"
Months="0"
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
|
RECOVERY FROM SURGERY AND ANESTHESIA IA USUALLY OBSERVED THROUGH CONVENTIONAL INDICATORS. THE QUALITY OF RECOVERY SCORE WAS SPECIALLY DESIGNED TO MEASURE PSYCHOMETRIC AND FUNCTIONAL RECOVERY FROM THE PATIENTS PERSPECTIVE. THIS STUDY AIMS TO EVALUATE THE SCORE FOLLOWING THE ADMINISTRATION OF IV LIGNOCAINE VS IV FENTANYL IN PATIENTS UNDERGOING SEPTOPLASTY SURGERY |