| CTRI Number |
CTRI/2024/04/065997 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Study to comparison of Intravenous Lidocaine and dexmedetomidine Infusions on quality of recovery In ENT surgeries. A Randomized, Double-Blinded, Controlled trial |
|
Scientific Title of Study
|
Comparison of Intravenous Lidocaine and dexmedetomidine Infusions on quality of recovery (QoR-15) and quality of surgical field in functional endoscopic sinus surgery (FESS): A Randomized, Double-Blinded, 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 Priyanka Dwivedi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS GKP |
| Address |
Department of Anaesthesiology Pain and Critical Care Medicine
All India Institute of Medical Sciences Gorakhpur
All India Institute of Medical Sciences Gorakhpur, Kunraghat
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
8795453444 |
| Fax |
|
| Email |
drpriyad1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Dwivedi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS GKP |
| Address |
Department of Anaesthesiology Pain and Critical Care Medicine
All India Institute of Medical Sciences Gorakhpur
All India Institute of Medical Sciences Gorakhpur, Kunraghat
UTTAR PRADESH
273008
India |
| Phone |
8795453444 |
| Fax |
|
| Email |
drpriyad1111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Dwivedi |
| Designation |
Associate Professor |
| Affiliation |
AIIMS GKP |
| Address |
Department of Anaesthesiology Pain and Critical Care Medicine
All India Institute of Medical Sciences Gorakhpur
All India Institute of Medical Sciences Gorakhpur, Kunraghat
UTTAR PRADESH
273008
India |
| Phone |
8795453444 |
| Fax |
|
| Email |
drpriyad1111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Priyanka Dwivedi
Department of Anaesthesiology, Pain and Critical Care Medicine,
All India Institute of Medical sciences, Gorakhpur, Uttar Pradesh, India, 273008 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pain and Critical Care Medicine
All India Institute of Medical Sciences, Gorakhpur
Contact no -8795453444 |
| Type of Sponsor |
Government 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 Priyanka Dwivedi |
All India Institute of Medical Sciences Kunraghat Gorakhpur |
major OT Complex, Department of Anaesthesia, All India Institute of Medical Sciences Kunraghat, Gorakhpur
Gorakhpur
UTTAR PRADESH |
8795453444
drpriyad1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, All India Institute of Medical Sciences, Gorakhpur Uttar Pradesh, India-273008 |
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 |
Group 1(Placebo) |
Dose- Equal volume of 0.9% sodium chloride as the Lidocaine group (both the loading, and the infusion)
route of administration- intravenous frequency- continuous duration- intra-operative period |
| Intervention |
Group 2 (L) |
dose- Loading dose of IV lidocaine 1.5 mg/kg slowly just before induction of anesthesia,
then the lidocaine infusion started at a rate of 1.5 mg/kg/h.
route of administration- intravenous
frequency- continuous
duration- intra-operative period
|
| Intervention |
Group 3 (D) |
Dose- Loading dose of IV Dexmedetomidine 1 µg/kg slowly just before induction of anesthesia, then the dexmedetomidine infusion started at a rate of 0.5 µg/kg/h.
route of administration- intravenous frequency- continuous duration- intra-operative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 - 60 years old, of either sex, American Society of Anesthesiologists physical status (ASA) I and II, who are scheduled for elective functional endoscopic sinus surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient’s refusal,
Allergies to local anesthetic drugs
Significant cardiovascular disease,
hepatic dysfunction or renal dysfunction,
Known coagulation defects,
Inability to communicate,
Chronic opioid usage,
Poorly controlled hypertension,
Use of B- Blockers,
History of Bradycardia episodes /Atrio-ventricular block / Conduction defects. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean/median QoR-15 score 24 hours after surgery between patients treated with lidocaine, dexmedetomidine infusion and placebo infusion |
Mean/median QoR-15 score 24 hours after surgery between patients treated with lidocaine, dexmedetomidine infusion and placebo infusion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean /median quality of surgical field score (for the severity of bleeding and the need for frequent suctioning) among study groups
Mean total analgesic consumption in the first 24 postoperative hours (Intra-operative + post- operative analgesic consumption) among study groups
Mean changes in hemodynamic parameters such as Heart rate (HR) and Blood pressure (Systolic, Diastolic, Mean) among study groups
Percentage of patients experiencing adverse events or complications if any. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 4 |
|
Date of First Enrollment (India)
|
28/05/2024 |
| 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 Yet Recruiting |
| 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 proposed study will be a single institution, double-blinded, prospective randomized placebo-controlled trial conducted on 96 patients aged 18 - 60 years old, of either sex, American Society of Anesthesiologists physical status (ASA) I and II, who are scheduled for elective functional endoscopic sinus surgery under general anaesthesia. Patients will be randomly divided in to 3 groups. Group 1 (L): Loading dose of IV lidocaine 1.5 mg/kg slowly just before induction of anesthesia, then the lidocaine infusion started at a rate of 1.5 mg/kg/h.
Group 3 (D):): Loading dose of IV Dexmedetomidine 1 µg/kg slowly just before induction of anesthesia, then the dexmedetomidine infusion started at a rate of 0.5 µg/kg/h.
Group 2(Placebo): Equal volume of 0.9% sodium chloride as the Lidocaine group (both the loading, and the infusion)
Patients will be evaluated for Mean/median QoR-15 score 24 hours after surgery between patients treated with lidocaine infusion and placebo infusion (Primary outcome) and Mean /median quality of surgical field score (for the severity of bleeding and the need for frequent suctioning) among study groups, Mean total analgesic consumption in the first 24 postoperative hours (Intra-operative + post- operative analgesic consumption) among study groups, Mean changes in hemodynamic parameters such as Heart rate (HR) and Blood pressure (Systolic, Diastolic, Mean) among study groups and Percentage of patients experiencing adverse events or complications if any. |