| CTRI Number |
CTRI/2021/10/037358 [Registered on: 18/10/2021] Trial Registered Prospectively |
| Last Modified On: |
23/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study effectiveness of 2 different medicines in preventing change in patient vitals both before and after inserting an airway device in patients taken for surgery |
|
Scientific Title of Study
|
“COMPARISON OF DEXMEDETOMIDINE-PROPOFOL
VERSUS FENTANYL-PROPOFOL FOR INSERTION OF
BLOCKBUSTER-LMA UNDER GENERAL ANAESTHESIA -A
RANDOMIZED DOUBLE-BLINDED CLINICAL TRIAL†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANUBHUTI JAIN |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
jhalawar medical college, jhalawar |
| Address |
Dr ANUBHUTI JAIN
ANESTHESIOLOGY DEPARTMENT
JHALAWAR MEDICAL COLLEGE AND SRG HOSPITAL. JHALAWAR
Jhalawar
RAJASTHAN
326001
India |
| Phone |
8426887699 |
| Fax |
|
| Email |
dranubhutijain0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANUBHUTI JAIN |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
jhalawar medical college, jhalawar |
| Address |
Dr ANUBHUTI JAIN
ANESTHESIOLOGY DEPARTMENT
JHALAWAR MEDICAL COLLEGE AND SRG HOSPITAL. JHALAWAR
RAJASTHAN
326001
India |
| Phone |
8426887699 |
| Fax |
|
| Email |
dranubhutijain0@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANUBHUTI JAIN |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
jhalawar medical college, jhalawar |
| Address |
Dr ANUBHUTI JAIN
ANESTHESIOLOGY DEPARTMENT
JHALAWAR MEDICAL COLLEGE AND SRG HOSPITAL. JHALAWAR
RAJASTHAN
326001
India |
| Phone |
8426887699 |
| Fax |
|
| Email |
dranubhutijain0@gmail.com |
|
|
Source of Monetary or Material Support
|
| JHALAWAR MEDICAL COLLEGE AND SRG HOSPITAL, JHALAWAR, RAJASTHAN |
|
|
Primary Sponsor
|
| Name |
JHALAWAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
ANESTHESIOLOGY DEPARTMENT
JHALAWAR MEDICAL COLLEGE
JHALAWAR, RAJASTHAN |
| 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 NEELU SHARMA |
JHALAWAR MEDICAL COLLEGE AND SRG HOSPITAL, JHALAWAR |
1ST FLOOR
ANESTHESIOLOGY DEPARTMENT
SRG HOSPITAL AND JHALAWAR MEDICAL COLLEGE
Jhalawar
RAJASTHAN |
9782480455
drneelu13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, JHALAWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
using blockbuster-Laryngeal mask airway for blind intubation in General anesthesia cases |
blind intubation via blockbuster intubating laryngeal mask airway in all 120 patients allocated randomly in 3 groups including study drug DEXMEDETOMIDINE OR FENTANYL with or without propofol for induction of general anesthesia |
| Comparator Agent |
DEXMEDETOMIDINE |
SEDATIVE ANALGESIC ALFA-2 AGONIST DRUG- 1ug/kg to be given by intravenous route as an infusion over 10mins prior to insertion of LMA |
| Comparator Agent |
FENTANYL |
AN OPIOID - ANALGESIC DRUG -1ug/kg dose to be given by intravenous route as an infusion over time of 10mins prior to insertion of LMA |
| Comparator Agent |
PROPOFOL |
GABA RECEPTOR ACTIVITY - SEDATIVE DRUG -2mg/kg given slowly by intravenous route after giving study drug and just before insertion of LMA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a) ASA grade I and II.
b) Aged 18-50 years.
c) MPG I and II
d) Either gender undergoing general anaesthesia.
e) Elective surgeries ≤ 120mins
f) Weight- 50 -80 kg |
|
| ExclusionCriteria |
| Details |
a) Difficulty in understanding the study protocol/ denying consent
b) History of sleep apnoea
c) Known allergy to the study medication
d) Bronchial asthma
e) Respiratory or cardiac dysfunction
f) Acute upper respiratory tract infection
g) Renal, cerebral insufficiency
h) Liver impairment and bleeding disorders
i) Hiatus hernia, pregnancy, emergency surgeries
j) Taking medications for psychiatric diseases
k) Chronic or acute intake of sedative or analgesic drugs. |
|
|
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 |
1.Monitoring of haemodynamic parameters,
2.ETCO2 and
3.SpO2 during insertion of device |
baseline vitals ,vitals before and after giving study drug , vitals every 1 min upto 30 mins intraop. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Quality of insertion :
(a) Ease of insertion
(b) Number of attempts
(c) Time taken for insertion
2.Manoeuvres used for intubation
3. Peri- and post-operative complications |
starting from preop.baseline values, during performing procedure and hourly upto 24hours post.op |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/10/2021 |
| Date of Study Completion (India) |
20/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/05/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
AIMS AND OBJECTIVES:
Study “COMPARISON OF DEXMEDETOMIDINE-PROPOFOL VERSUS FENTANYL-PROPOFOL FOR INSERTION OF BLOCKBUSTER LMA UNDER GENERAL ANAESTHESIA - A RANDOMIZED DOUBLE-BLINDED CLINICAL TRIAL†will be done in 120 ASA grade I & II patients to compare: -
1. Primary objective- ï‚· Monitoring of haemodynamic parameters, ï‚· ETCO2 and ï‚· SpO 2 during insertion of device 2. Secondary objective- ï‚· Quality of insertion : (a) Ease of insertion (b) Number of attempts (c) Time taken for insertion
ï‚· Manoeuvres used for intubation ï‚· Peri- and post-operative complications
SAMPLE SIZE SELECTION: Sample size will be calculated by using open epi software version 6, open source calculator ss proper, at power 80% and 95% confidence interval is 40 in each group.
SELECTION OF GROUPS: The patients will be randomly divided into 3 groups with 40 in each group, using computer generated random numbers.  Group PD - 1 µg/kg dexmedetomidine diluted to 10 ml with 0.9% normal saline (NS) over ten minutes by an infusion pump followed by 5 ml of NS over 2 minutes.  Group PF - Injection fentanyl 1 µg/kg diluted to 10 ml with 0.9% NS over 10 minutes by an infusion pump followed by 5 ml of NS over 2 minutes.  Group P – only 10ml NS & 5ml NS will be given over 10mins and 2 mins respectively by an infusion pump. |