| CTRI Number |
CTRI/2023/09/057750 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
15/09/2023 |
| 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
|
To compare nebulized magnesium sulphate with nebulized lignocaine in attenuating pressor response to laryngoscopy and intubation in patients undergoing general anaesthesia |
|
Scientific Title of Study
|
A prospective randomized study to compare nebulized magnesium sulphate with nebulized lignocaine in attenuating pressor response to laryngoscopy and intubation in patients undergoing 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 SURESH KUMAR SINGHAL |
| Designation |
SENIOR PROFFESSOR AND HOD |
| Affiliation |
PT.B.D.SHARMA,PGIMS ROHTAK |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICSAL CARE,PT.B.D.SHARMA,PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9416391115 |
| Fax |
|
| Email |
ssinghal12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MOHIT |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICSAL CARE,PT.B.D.SHARMA,PGIMS ROHTAK |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICSAL CARE,PT.B.D.SHARMA,PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9034133070 |
| Fax |
|
| Email |
mohithalder28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MOHIT |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICSAL CARE,PT.B.D.SHARMA,PGIMS ROHTAK |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICSAL CARE,PT.B.D.SHARMA,PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9034133070 |
| Fax |
|
| Email |
mohithalder28@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT.B.D.SHARMA,PGIMS ROHTAK |
|
|
Primary Sponsor
|
| Name |
PT.B.D.SHARMA,PGIMS ROHTAK |
| Address |
ROHTAK,HARYANA |
| 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 |
| DRMOHIT |
PT.B.D.SHARMA PGIMS UNIVERSITY OF HEALTH SCIENCES,ROHTAK |
DEPARTMENT OF ANAESTHESIOLOGYPT.B.D.SHARMA PGIMS UNIVERSITY OF HEALTH SCIENCES,ROHTAK,HARYANA124001
Rohtak
HARYANA |
9034133070
mohithalder28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B. D. Sharma PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nebulized Lignocaine 2% |
After arrival to OT, baseline vitals will be noted. IV line secured with 18 or 20G cannula. Patient will be nebulized with 5 ml of 2% Lignocaine. Nebulization will continue until the complete solution in the nebulizer got aerosolized (10–12 min). Vital parameters will be recorded after the completion of nebulization (V1). Preoxygenation will be done for 3 min. with 100% oxygen. Patient will be induced with inj. fentanyl 2mcg/kg and inj. thiopentone sodium 5mg/kg. After check ventilation, the neuromuscular blockade will be achieved with vecuronium 0.1 mg/kg.
Intermittent positive pressure ventilation will be performed with N2O in O2 (50:50) with sevoflurane.
Airway will be secured using endotracheal tube of size 7 mm
in female and 8 mm in male under direct laryngoscopy. Vital parameters will be recorded before laryngoscopy (v2), at 1 min after intubation (v3), 3 min after
intubation (v4) and 5 min after intubation (v5). Time taken for endotracheal intubation will be calculated from beginning of laryngoscopy till successful placement of endotracheal tube confirmed by capnography. Patient requiring more than 18 sec for intubation, or more than 1 attempts will also be excluded from the study. Patient with unexpected difficult airway will be excluded. Rest of anesthesia will continue as per standard protocols.
|
| Intervention |
Nebulized Magnesium sulphate |
After arrival to OT, baseline vitals will be noted. IV line secured with 18 or 20G cannula. Pt. will receive nebulization with 5ml solution containing 500 mg Magnesium.
sulphate in normal saline. Nebulization will continue until the complete solution in the nebulizer got aerosolized (10–12 min).
Vital parameters will be
recorded after the completion of nebulization (V1). Preoxygenation will be done for 3 min with 100% oxygen. Patient will be induced with inj. fentanyl 2mcg/kg and inj. thiopentone sodium 5mg/kg. After check ventilation, the neuromuscular blockade will be achieved with vecuronium 0.1 mg/kg.
Intermittent positive pressure ventilation will be performed with N2O in O2 (50:50) with sevoflurane. Airway will be secured using endotracheal tube of size 7mm.
in female and 8mm. in male under direct laryngoscopy. Vital parameters will be recorded before laryngoscopy (v2), at 1 min after intubation (v3), 3 min after
intubation (v4) and 5 min after intubation (v5). Time taken for endotracheal intubation will be
calculated from beginning of laryngoscopy till successful placement of endotracheal tube
confirmed by capnography. Patient requiring more than 18 sec for intubation or more than 1
attempts will also be excluded from the study. Patient with unexpected difficult airway will be excluded. Rest of anesthesia will continue as per standard protocols.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
ASA Grade I and II patients of either sex in age group of 18-60 years posted for surgery under general anaesthesia, who are either sex and willing to participate will be included in this study. |
|
| ExclusionCriteria |
| Details |
patients with refusal of consent, history of hypertension, patients having cardiovascular dysfunction, epilepsy, pregnancy, anticipated difficult airway, patients with known history of allergy to study drug. |
|
|
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 ASSESS EFFICACY OF NEBULIZED MAGNESIUM SULPHATE IN COMPARISON TO NEBULIZED LIGNOCAINE ON HYPERTENSIVE TACHYCARDIA RESPONSE TO LARYNGOSCOPY ANMD INTUBATION DURING GENERAL ANAESTHESIA |
AFTER INTUBATION 1MIN,3MIN,5MIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE SIDE EFFECTS ASSOCIATED WITH USE OF THESE DRUG,IF ANY1.HYPOTENSION 2.BRADYCARDIA 3. FALL IN SATURATION 4.ANY OTHER |
WITHIN 30 MIN |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
03/10/2023 |
| 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 Yet Recruiting |
| 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
|
ASA 1 and 2 patients of either sex aged 18 to 60 years scheduled for elective surgery under general anaesthesia requiring endotracheal intubation will be nebulized, group-M (40 patients) with 5 ml solution containing 500 mg magnesium sulphate in normal saline and group-L (40 patients) with 5ml of 2% lignocaine to attenuate pressor response to laryngoscopy and intubation. |