| CTRI Number |
CTRI/2025/03/081941 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Dexmedetomidine with Magnesium Sulphate by Nebulization to
attenuate hemodynamic stress response to Intubation in Patients undergoing elective surgery under General Anaesthesia |
|
Scientific Title of Study
|
Comparative Evaluation Of Dexmedetomidine versus Magnesium Sulphate by Nebulization to attenuate hemodynamic stress response to
Intubation in Patients undergoing elective surgery under General Anaesthesia |
| 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 Lavania Garg |
| Designation |
Junior resident |
| Affiliation |
GGSMCH, Faridkot |
| Address |
Dept of Anesthesia ,GGSMCH, Faridkot, Punjab ,India
Faridkot
PUNJAB
151203
India |
| Phone |
8427849483 |
| Fax |
|
| Email |
garglavania4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kewal Krishan Gupta |
| Designation |
Professor |
| Affiliation |
GGSMCH,Faridkot |
| Address |
Dept of Anesthesia ,GGSMCH, Faridkot, Punjab ,India
PUNJAB
151203
India |
| Phone |
9781812052 |
| Fax |
|
| Email |
doc_krishan31@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kewal Krishan Gupta |
| Designation |
Professor |
| Affiliation |
GGSMCH,Faridkot |
| Address |
Dept of Anesthesia ,GGSMCH, Faridkot, Punjab ,India
PUNJAB
151203
India |
| Phone |
9781812052 |
| Fax |
|
| Email |
doc_krishan31@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dept of Anesthesia ,GGSMCH, Faridkot, Punjab ,India,151203 |
|
|
Primary Sponsor
|
| Name |
Guru Gobind Singh Medical College Hospital |
| Address |
Dept of Anesthesia ,GGSMCH, Faridkot, Punjab ,India 151203 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrGagandeep |
Dept of Anesthesia ,GGSMCH, Faridkot. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Lavania Garg |
Guru Gobind Singh Medical College and Hospital |
Dept of Anesthesia ,GGSMCH, Faridkot, Punjab ,India
Faridkot
PUNJAB |
8427849483
garglavania4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of GGSMCH, Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (3) ICD-10 Condition: N63||Unspecified lump in breast, (4) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Dexmedetomidine in a dose of 1 mcg/kg will be diluted in normal saline up to 5 ml, and nebulisation will be done with oxygen at a rate of 8-10 l/min, 15 to 20 min before anesthesia induction. |
| Comparator Agent |
Magnesium Sulphate |
Magnesium Sulphate in a dose of 30mg/kg will be diluted in normal saline up to 5 ml, and nebulisation will be done with oxygen at a rate of 8-10 l/min, 15 to 20 min before anesthesia induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing surgeries under general anaesthesia.
2. Patients of age group between 18 to 65 years of either gender.
3. American Society of Anaesthesiologist grade I and II.
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of allergy to the study drugs.
2. Patients in whom intubation time exceeded 20 seconds or in cases where first attempt to intubate has failed.
3. Refusal of consent.
4. Patients with body mass index (BMI) more than 30 kg/m2, a history of cardiovascular diseases like ischaemic heart disease and uncontrolled hypertension, a history of alcohol intake, chronic analgesic or drug abuse, and pregnant patients will be excluded from the study.
5. Patients with difficult airway (for example: mouth opening less than 2 fingers, MPG more than 2,
6. Neck movement: flexion / extension -limited). |
|
|
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 evaluate the alteration in the hemodynamic stress response to intubation in terms of Systolic Blood Pressure with nebulized dexmedetomidine (1ug/kg)
To evaluate the alteration in the hemodynamic stress response to intubation in terms of Systolic Blood Pressure with nebulized magnesium sulphate (30mg/kg) |
Baseline,immediately after nebulization,1 minute after tracheal intubation, 5 minutes after tracheal intubation,10 minutes after tracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the DBP, HR, MAP, SpO2 with nebulized dexmedetomidine (1ug/kg) and with nebulized magnesium sulphate (30mg/kg) |
Till 10 mins of intubation |
| To compare the incidence of hypotension, bradycardia or sedation after nebulization with Dexmedetomidine and Magnesium Sulphate |
Till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
10/03/2025 |
| 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
|
A
randomized, prospective, double blinded interventional comparative study will
be conducted on 120 patients undergoing surgeries under general anaesthesia.
Patients were randomized into 2 groups, of 60 each to be nebulised with
magnesium sulphate (30mg/kg(Group M)) ,dexmedetomidine(1mcg/kg(Group D))
diluted upto 5ml before induction. Readings of systolic blood pressure (SBP),
diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR),
will be recorded at various time intervals.
|