1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. 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
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response (Others) -  dr_jatinpatel@yahoo.co.in


6. For how long will this data be available start date provided 18-12-2025 and end date provided 15-12-2028?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

To compare the efficacy of intravenous Dexmedetomidine versus Magnesium sulfate in attenuating blood pressure during

laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anasethesia.

INCLUSION CRITERIA

Patients willing to sign written & informed consent.

Male or female patients between ages of 18 to 60 years.

Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.

Patients posted for elective spine surgeries under general anesthesia

EXCLUSION CRITERIA

Patients unwilling to participate in the study.

Patients with cardiovascular, cerebrovascular, hepatic and renal diseases.

Patients having arrhythmias or heart block.

 Psychiatric patients.

Pregnancy & lactating women.

Patients taking beta blockers.

History of allergy to the study drugs.

 Anticipated difficult airway.

 BMI greater than 30

 Patient having Neuromuscular disease

Serum magnesium level greater than 2.5mEq per L

Site of Study: Department of Anesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara, Gujarat.

Study Design- Prospective comperative study

Study Duration- The study will be initiated after obtaining the permission from institutional ethics committee till the achievement of the sample size or 18 months whichever is earlier.

Data will be collected & tabulated. Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. As regard to numerical variables; tests like unpaired student–t test and/or ANNOVA will be used whenever appropriate for between-groups comparisons, while for categorical variables; chi–square test will be used. p value <0.05 will be considered statistically significant.

LIKELY OUTCOME

This prospective and observational study will help us to compare the efficacy of  intravenous

Dexmedetomidine versus  intravenous Magnesium sulphate for attenuation of the pressor response to

larngoscopy and endotracheal intubation and will enable us to know which of the two drugs is most

beneficial in providing better attenuation of the hemodynamic response to larngoscopy and endotracheal

intubation.