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) -  drtejash@gmail.com


6. For how long will this data be available start date provided 24-09-2025 and end date provided 26-07-2029?
   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

A comparative study of clonidine and gabapentin as an oral premedication on hemodynamic response to laryngoscopy and tracheal. intubation.

To compare the clonidine and gabapentin given orally as premedication, reduces changes in blood pressure and heart rate during laryngoscopy and tracheal intubation.

Inclusion Criteria:

·      Patients will be willing to sign written and informed consent.

·      Male or female patients between 18 to 60 years of age.

·      Patients will belonging to American Society of Anaesthesiologists (ASA) physical status   I and II.

·      Patients will be posted for elective surgeries under general anaesthesia.

Exclusion Criteria:

·      Patients unwilling to participate in the study.

·      Patients with Body Mass Index ≥ 30 kg/m².

·      Patients with history of muscular disorder ; myositis, myoclonus, myasthenia gravis.

·      Patients with cardiovascular diseases, arrhythmias, heart blocks, or taking beta blockers.

·      Patients with cerebrovascular, hepatic and renal diseases.

·      Psychiatric patients.

·      Patients will blur vision

·      Patients with history of allergy to an α-2 adrenergic agonist

·      Pregnancy & lactating women.

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

Study Design- comparative and randomized study

METHODOLOGY

·       Patients will be kept Nil Per Orally (NPO) 6 hours and 4 hours prior to surgery for solids and clear liquids respectively, before surgery.

·       Written informed consent will be taken from the patients who are fulfilling the criteria.

·       On the day of operation, all the participants will be shifted to preoperative area 1 hour before the operation time. All standard monitors like pulse oximeter, non-invasive blood pressure (NIBP) will be attached and baseline haemodynamic parameters will be recorded in preoperative room. An 18-gauge (18G) peripheral venous cannula will be secured and IV Ringer’s Lactate solution will be administered as maintenance fluid (80ml/hr) through it.

·       The consultant anaesthesiologist will be give orally tablet clonidine 0.2mg 30 minutes prior to induction of general anaesthesia in Group Dc patients.

·       And in Group Dg patients the consultant anaesthesiologist will administer orally tablet gabapentin 800mg 30 minutes before induction of anaesthesia

LIKELY OUTCOME / BENEFITS OF THE STUDY

This study will help us to compare the efficacy between oral clonidine and gabapentin in  hemodynamic responses to laryngoscopy and endotracheal intubation in patients undergoing surgeries under general  anaesthesia and will enable us to know which drug will given orally  is most beneficial in giving balanced general anaesthesia by having better outcomes in hemodynamics.