| CTRI Number |
CTRI/2025/09/094354 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the Effects of Magnesium and Fentanyl on Heart and Blood Pressure Responses During Nasal Intubation in Oral Cancer Surgery |
|
Scientific Title of Study
|
Comparative study of effect of intravenous magnesium sulphate and fentanyl on hemodynamic responses to nasal intubation and laryngoscopy in oral cancer patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Gattani |
| Designation |
Junior resident |
| Affiliation |
Datta Meghe Institute Of Medical Science And Research |
| Address |
Department of anaesthesiology
JNMC Wardha
Jawaharlal Nehru Medical college sawangi Meghe Wardha
Department of anaesthesiology
Wardha
MAHARASHTRA
442001
India |
| Phone |
7798331431 |
| Fax |
|
| Email |
rgattani.218@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeta Chaudhary Verma |
| Designation |
Proffesor |
| Affiliation |
Datta Meghe Institute Of Medical Science And Research |
| Address |
Department of anaesthesiology
JNMC wardha
Jawaharlal Nehru Medical college sawangi Meghe Wardha
Department of anaesthesiology
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788378382 |
| Fax |
|
| Email |
neetachaudhary1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeta Chaudhary Verma |
| Designation |
Proffesor |
| Affiliation |
Datta Meghe Institute Of Medical Science And Research |
| Address |
Department of anaesthesiology
JNMc Wardha
Jawaharlal Nehru Medical college sawangi Meghe Wardha
Department of anaesthesiology
Wardha
MAHARASHTRA
442001
India |
| Phone |
8788378382 |
| Fax |
|
| Email |
neetachaudhary1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical Sciences And Research center ,Sawangi Meghe Wardha 442001, Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
JNMC |
| Address |
Sawangi Meghe Wardha Maharashtra India 442001 |
| 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 Rahul Gattani |
Datta Meghe Institute Of Health Sciences |
Department of anaesthesiology Jawaharlal Nehru Medical College Sawangi Meghe wardha
Wardha
MAHARASHTRA |
7798331431
rgttani.218@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of heigher Education And Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age: 25 to 60 years.
Diagnosed with oral cancer requiring elective surgery under general Anaesthesia with nasal intubation.
ASA Physical Status: Classified as ASA III
Informed Consent: written informed consent, in the case of minors or those unable to consent, consent obtained from their legal guardians.
General Health: Patients with no contraindications for either magnesium sulphate or fentanyl administration.
Planned Surgery: Patients scheduled for elective oral cancer surgery
|
|
| ExclusionCriteria |
| Details |
Renal Impairment: Patients with renal insufficiency or chronic kidney disease (CKD), as magnesium sulphate may cause toxicity in those with impaired renal function.
Respiratory Conditions: Patients with severe chronic obstructive pulmonary disease (COPD), asthma, or other significant pulmonary diseases
Neurological Disorders: Patients with neuromuscular disorders (e.g., myasthenia gravis) that may be exacerbated by the NMDA receptor antagonist properties of magnesium sulphate.
Allergic Reactions: Patients with a known allergy or hypersensitivity to magnesium sulphate, fentanyl, or any other opioids.
Pregnancy or Lactation: or breastfeeding women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intravenous magnesium sulphate will be more effective than fentanyl in providing sustained attenuation of hemodynamic responses (heart rate and blood pressure) during nasal intubation in oral cancer patients. |
15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To determine the duration of hemodynamic control offered by each drug following intubation.
2)To assess the need for additional pharmacological intervention in either group to maintain hemodynamic stability during or after intubation.
3)To evaluate patient outcomes and anaesthetic recovery characteristics, such as time to extubation or postoperative cardiovascular complications, if applicable. |
15 minutes |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
06/10/2025 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 30-04-2025 and end date provided 30-04-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective, randomized study at Acharya Vinoba Bhave Rural Hospital (2024–2027) compares IV magnesium sulphate (30 mg/kg) and fentanyl (2 mcg/kg) for controlling heart rate and blood pressure during nasal intubation in oral cancer patients. Sixty-four patients are randomized into two groups. Both groups receive standardized anesthesia and peri-induction drugs. Hemodynamic parameters, number of intubation attempts, interventions for instability, and adverse events are systematically documented. The study aims to determine which drug provides superior, sustained blunting of cardiovascular responses, with findings expected to guide safer anesthesia practices and future research on optimal agents for high-risk airway management
|