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CTRI Number  CTRI/2025/08/093322 [Registered on: 20/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Does Taking Pregabalin Before Surgery Help With Anaesthesia and Recovery for those who receiving General Anesthesia  
Scientific Title of Study   Effect of Oral Pregabalin Premedication on Perioperative Anesthesia Outcomes in Patients Undergoing Surgery Under General Anesthesia: A Double-Blind Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JAYABHARATHI K V 
Designation  MD ANESTHESIOLOGY 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anesthesiology, Pondicherry Institute of Medical Sciences, Village no 20,Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry 605014

Pondicherry
PONDICHERRY
605014
India 
Phone  9843799437  
Fax    
Email  puppysrm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR RAMYAVEL  
Designation  Professor Department of ANESTHESIOLOGY 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anesthesiology, Pondicherry Institute of Medical Sciences,Village no 20 Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014

Pondicherry
PONDICHERRY
605014
India 
Phone  9487630425  
Fax    
Email  ramyavel1988@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR JAYABHARATHI K V  
Designation  MD ANESTHESIOLOGY 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anesthesiology,Pondicherry Institute of Medical Sciences, Village no 20,Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014, India

Pondicherry
PONDICHERRY
605014
India 
Phone  9843799437  
Fax    
Email  puppysrm@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Pondicherry Institute of Medical Sciences,Kalathumettupathai, Ganapathichettikulam Village No.20, Kalapet, Puducherry 605014 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr JAYABHARATHI K V  Department of Anesthesiology, Pondicherry Institute of Medical Sciences  Department of Anesthesiology , Village no 20, Kalathumettupathai, Ganapathichettikulam Village, Kalapet, Puducherry 605014
Pondicherry
PONDICHERRY 
9843799437

puppysrm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS Institute of Ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  oral pregabalin   In these patients, oral pregabalin 75mg will be pre-medicatd at two occasions, one at prior night and other at morning approximately 2 hours prior to shifting to OT for surgery. 
Comparator Agent  PLACEBO   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 approximately 2 hours prior to shifting to OT for surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • ASA I and II ( American society of Anesthesiologist classification )
• Patient undergoing elective surgery under general anaesthesia
 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare postoperative pain using NRS rating scale between oral pregabalin group vs placebo in patient undergoing surgery under general anaesthesia   It is assessed for first 24 hours postoperative period. Assessed postoperative period at baseline,30 minutes ,1 hour,2 hours,4 hours,8 hours,12 hours,24 hours at the end of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To compare
Pre-operative anxiety score using APAIS
Stress response to laryngoscopy & intraoperative hemodynamics
Postoperative recovery using Aldrette scoring
Postoperative sedation between two groups using Ramsay sedation score.
 
Assessed postoperative period at baseline,30 minutes ,1 hour,2 hours,4 hours,8 hours,12 hours,24 hours at the end of surgery  
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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   Phase 3 
Date of First Enrollment (India)   30/08/2025 
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 - NO
Brief Summary  

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.

 
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