Effect of Oral Pregabalin Premedication on Perioperative Anesthesia Outcomes in Patients Undergoing Surgery Under General Anesthesia: A Double-Blind Randomized Controlled Trial

1.After obtaining ethical committee clearance of Pondicherry Institute of Medical Sciences and informed written consent, this prospective, randomized, controlled ñ will be conducted among 64 patients aged 18-60 years of American Society of mAnaesthesiologists (ASA) physical status I and II.A thorough pre-anaesthetic check-up including detailed history, general and systemic examination and review of subjective investigations will be conducted on the day before surgery. All patients will be explained about the numerical rating scale (NRS), APAIS questionnaire and Ramsay sedation score preoperatively. After ensuring nil per oral for a period of 8

hours, all the patients will be premedicated with Tab. Pantoprazole 40mg, Tab. Ondansetron 4mg on the night prior and on the day of surgery approximately 2 hours before surgery .After Pre-medication, the patients will be divided into two groups, A and B based on computer generated block randomisation.

GROUP A- (Pregabalin group):

In these patients, oral pregabalin 150 mg will be administered at two

occasions, one at prior night & other at morning approximately 2 hours

prior to shifting to OT for surgery.

GROUP B- (Control group):

In these patients, identical capsules containing glucose powder as

placebo will be administered orally at same two occasions, one at prior

night and other at morning 2 hours prior to shifting to OT for surgery.

On the day of surgery, a detailed pre anaesthetic checkup will be

done for all patients who satisfy inclusion criteria.All patient will be

briefed about assessment to be performed and a valid written informed

consent will be obtained in the language they understand. Preoperative

APAIS score to assess anxiety day before premedication will

administered. Patient shifted to operation table and connected to

standard ASA monitors like Pulse oximetry, electrocardiogram (ECG),

noninvasive blood pressure (NIBP) and the baseline hemodynamic

parameters will be recorded .

General anaesthesia will be administered based on standard

anaesthesia practice.Injection Propofol will be used as an inductional

agent and amount of propofol used for induction will be documented.

Patient will be intubated and controlled ventilation adopted. Anaesthesiawill be maintained with oxygen: nitrous oxide: isoflurane mixture.Any

increase in heart rate, blood pressure >20% from the baseline during

maintenance phase will be treated by increasing dose of inhalational

agent or by administration of repeated bolus doses of fentanyl based on

discretion of an anaesthesiologist and noted done.At the end of surgery

patient extubated and shifted to recovery room ,aldrete time to achieve

>9 score will be noted and shifted to ward. In postoperative period

analgesia will be maintained with Injection.paracetamol 1 gm or

Injection Diclofenac 75mg at every 8 hourly to patient on standard

practice. Any complaint of pain by patient NRS scale >4 injection

Nalbuphine 10mg intravenously and noted down. Other parameters

assessed would include post-operative sedation in the form of Ramsay

sedation score and post-operative total analgesia requirement in t

he first

24 hours of post-surgery.