| CTRI Number |
CTRI/2022/01/039528 [Registered on: 18/01/2022] Trial Registered Prospectively |
| Last Modified On: |
19/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
Modification(s)
|
EFFICACY OF DEXMEDETOMIDINE VERSUS MAGNESIUM SULPHATE AND LIGNOCAINE IN LARYNGOSCOPY AND INTUBATION RESPONSE AND COMPARE THEM WITH OPIOID ANAESTHESIA |
|
Scientific Title of Study
|
TO EVALUATE AND COMPARE HEMODYNAMIC RESPONSE AND EFFICACY OF DEXMEDETOMIDINE VERSUS MAGNESIUM SULPHATE AND LIGNOCAINE IN PROVIDING OPIOID FREE GENERAL ANAESTHESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akanksha Sharma |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College , Shimla |
| Address |
Department of Anaesthesiology,
IGMC Shimla
Department of Anaesthesiology,
IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9805633110 |
| Fax |
|
| Email |
akanksha.kasauli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Kumar Panwar |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical College , Shimla |
| Address |
Department of Anaesthesiology,IGMC Shimla
Department of Anaesthesiology,IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418086876 |
| Fax |
|
| Email |
drmkpanwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Sharma |
| Designation |
Junior Resident |
| Affiliation |
Igmc |
| Address |
Department of Anaesthesiology,
IGMC Shimla
Department of Anaesthesiology,
IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
09805633110 |
| Fax |
|
| Email |
akanksha.kasauli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology IGMC Shimla |
|
|
Primary Sponsor
|
| Name |
Akanksha Sharma |
| Address |
Department of Anaesthesiology IGMC Shimla |
| 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 |
| Akanksha Sharma |
Indira Gandhi Medical College |
Department of Anaesthesiology IGMC Shimla
Shimla
HIMACHAL PRADESH |
9805633110
akanksha.kasauli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IGMC shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
Iv infusion of 0.75 mcg/kg DEXMEDETOMIDINE in 0.9%NS 20ml will be started 10mins before intubation and 4 ml NS for intubation |
| Comparator Agent |
Fentanyl |
Iv infusion of 0.9% NS 20ml will be started before intubation followed by 2mcg/kg diluted to 4ml for intubation |
| Intervention |
Magnesium sulphate and Lignocaine |
Iv infusion of MgSO4 30mg/kg +Lignocaine (preservative free)1.5 mg/kg totalled to 20ml over 10 minutes before intubation and 4ml NS for intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I & II |
|
| ExclusionCriteria |
| Details |
1. Pts with H/O uncontrolled HTN or hypotension
2. Bradycardia
3. Heart blocks
4. Pt with Cardiovascular disease
5. Allergies to any studies
6. BMI >30 kg/m2
7. Pts with more than one intubation attempt
8. Pts who refuse to give consent
|
|
|
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 |
To compare the effect of opioid free anaesthesia with opioid based anaesthesia on hemodynamic profile
HR,SBP,DBP,MAP,SpO2,any other |
Pre-infusion
Pre-induction
Baseline
1 min
5min
3 min
5 min
7 min
10 min
20 min
30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post op vital monitoring
Post op analgesia
Post op nausea , vomiting, sedation
Any complication |
0min
5min
10min
20min
30min
1hr
2hr
3hr |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
18/03/2022 |
| 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
|
Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM: To evaluate and compare hemodynamic response and efficacy of dexmedetomidine vs magnesium sulphate and lignocaine in providing the opioid free general anaesthesia. PRIMARY OBJECTIVE: To compare the effect of opioid free anaesthesia with opioid based anaesthesia on hemodynamic profile during laryngoscopy and endotracheal intubation. SECONDARY OBJECTIVES: 1. To evaluate post-operative analgesia in all groups. 2 To study post-operative nausea vomiting, sedation etc. 3. To note any other intra-operative and post-operative complication /adverse effects
Endotracheal intubation is considered a gold standard for airway management during the surgeries under general anaesthesia. Stimulation of proprioceptors at the base of the tongue during laryngoscopy induces impulse dependent tachycardia, hypertension and plasma catecholamine concentration and may be associated with sympathetic stimulation and increase in mean arterial pressure. Induction of general anaesthesia,laryngoscopy and tracheal intubation may cause acute hemodynamic instabilities. These changes in blood pressure have been associated with increased intracranial pressure,cerebral haemorrhage, myocardial ischaemia and cardiac failure. Therefore there is need to blunt these noxious responses effectively. Opioid agents have been a mainstay for both intra and post- operative analgesia, but they are largely associated with hyperalgesia, acute tolerance, higher analgesic consumption in post-operative period, prolonged sedation, ileus, urinary retention and prolonged length of hospital stay. Moreover, the dose of opioids required for effective attenuation of stress response is fairly high. These adverse effects of opioids are a point of concern in today’s scenario. New approaches and today’s emphasis is on multimodal and opioid free anaesthesia with sympathetic stability to protect organs and provide sufficient tissue perfusion,analgesia and rapid emergence .With emergence of newer non opioid analgesic agents, opioid therapy could be complemented and infact replaced by the newer agents. |