| CTRI Number |
CTRI/2024/03/064545 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Magnesium and Lignocaine in Reducing Stress During Airway Procedures: A Clinical Trial |
|
Scientific Title of Study
|
TO STUDY THE EFFICACY OF INTRAVENOUS MAGNESIUM SULPHATE WITH AND WITHOUT LIGNOCAINE SPRAY IN ATTENTUATING THE PRESSOR RESPONSE TO LARYNGOSCOPY AND INTUBATION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harini P |
| Designation |
Post graduate |
| Affiliation |
Mahatma Gandhi medical college, Pondicherry |
| Address |
Department of Anaesthesiology, 2nd floor, Mahatma Gandhi medical college and research institute, Pondicherry
Pondicherry PONDICHERRY 607402 India |
| Phone |
7358595571 |
| Fax |
|
| Email |
hariniparani98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Hemanth Kumar V R |
| Designation |
Professor, Head of department |
| Affiliation |
Mahatma Gandhi medical college, Pondicherry |
| Address |
Department of Anaesthesiology, 2nd floor, Mahatma Gandhi medical college and research institute, Pondicherry
Pondicherry PONDICHERRY 607402 India |
| Phone |
9003550553 |
| Fax |
|
| Email |
drvrhk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Hemanth Kumar V R |
| Designation |
Professor, Head of department |
| Affiliation |
Mahatma Gandhi medical college, Pondicherry |
| Address |
Department of Anaesthesiology, 2nd floor, Mahatma Gandhi medical college and research institute, Pondicherry
Pondicherry PONDICHERRY 607402 India |
| Phone |
9003550553 |
| Fax |
|
| Email |
drvrhk@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi medical college |
| Address |
Mahatma Gandhi medical college and research institute, Pondicherry - 607402 |
| Type of Sponsor |
Private 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 Harini P |
Mahatma gandhi medical college and research institute |
room number- 201, Department of anaesthesiology, 2nd floor, Mahatma Gandhi medical college and research institute, pondicherry Pondicherry PONDICHERRY |
7358595571
hariniparani98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee, MGMCRI, Puducherry |
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 |
| Comparator Agent |
intravenous magnesium sulphate (30mg/kg) with 10% lignocaine spray on the vocal cords |
to assess the pressor response attenuation during intubation with intravenous magnesium sulphate (30mg/kg) before induction of general anaesthesia and 10% lignocaine spray (4 puffs) on the vocal cords before intubation. |
| Intervention |
with intravenous magnesium sulphate (30mg/kg) |
to assess the pressor response attenuation during intubation with intravenous magnesium sulphate (30mg/kg) given before induction of general anaesthesia in ASA 1 and 2 patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. patients belonging to ASA grade I, II.
2. Patients posted for surgery under general anaesthesia
3. AGE - 18-60 years of age
4. SEX - Male and Female
|
|
| ExclusionCriteria |
| Details |
history of allergic to local anaesthetic agents
Patients with coronary artery disease
Difficult airway
hypertensive patients on two or more medications
BMI greater than 30 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the Heart rate and blood pressure variation due to pressor response between the two study groups.
|
To assess baseline heart rate and blood pressure and the variations after the administration of the test drug, during intubation, 2 minutes, 4 minutes, 6 minutes, 8 minutes and at 10 minutes after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess sedation score post extubation using Ramsay sedation scale between the two groups. |
to be assessed before shifting the patient to recovery room. |
|
|
Target Sample Size
|
Total Sample Size="88" Sample Size from India="88"
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 2 |
|
Date of First Enrollment (India)
|
31/03/2024 |
| 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="0" Months="8" 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
|
Depending on the study drug to be administered, the chosen patients will be randomized into 2 Groups, ML and M by computer generated randomization using sealedenvelope.com. Concealment will be done using sealed envelope technique. Group ML will receive intravenous MgSO4 (30 mg/kg) and 10% lignocaine spray; Group M will get intravenous MgSO4 (30 mg/kg). All patients will be pre-medicated with tab. Alprazolam 0.5 mg oral, the night before surgery and a minimum fasting state of six hours before anaesthesia will be ensured in all patients. On arrival in the operating room, standard monitoring such as electrocardiography, pulse oximetry (SpO2), non-invasive blood pressure monitoring will be connected to the patient and the baseline heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded. Prior to induction, pre-medications such as inj. Midazolam 0.05 mg/kg IV and inj. Morphine 0.1 mg/kg IV will be given, and all patients will be preoxygenated with 100% oxygen for three minutes. Prior to induction, both the groups will receive intravenous magnesium sulphate 30mg/kg as slow iv over two minutes. Induction will be carried out with injection propofol till the loss of verbal response. Muscle relaxation will be achieved with inj. vecuronium 0.1mg/kg after assessing adequacy of mask ventilation. Positive pressure mask ventilation will be provided to ensure adequate oxygenation and ventilation. Three minutes after giving vecuronium, laryngoscopy will be done, following which group ML patients will receive 10% Lignocaine spray. Positive pressure mask ventilation will be provided for two minutes after which laryngoscopy and tracheal intubation will be done. In group M, after administration of vecuronium, positive pressure mask ventilation will be done for three minutes. Then, laryngoscopy will be done followed by endotracheal intubation. An experienced anaesthesiologist will perform the laryngoscopy, and a suitable-sized cuffed endotracheal tube will be used for orotracheal intubation. Only patients whose intubation will be performed in a single try within 20 seconds and using a standard McIntosh curved blade laryngoscope will be included in the study. After intubation, surgical stimulation will not be allowed for 10 minutes. Maintenance of general anaesthesia, intraoperative monitoring and reversal of neuro-muscular blockade and extubation following the standard practice. Parameters like Heart Rate (HR); systolic blood pressure (SBP); diastolic blood pressure (DBP); mean arterial pressure (MAP) will be recorded at Baseline; after administration of the study drug; after administration of propofol; at laryngoscopy with spraying, immediately after intubation; at two, four, six, eight and at 10 minutes after induction. Patients will be carefully monitored for any complications including hypotension and bradycardia which will be managed by Inj. Mephentermine and Inj. Atropine accordingly. |