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CTRI Number  CTRI/2025/10/095689 [Registered on: 07/10/2025] Trial Registered Prospectively
Last Modified On: 02/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the two medication gabapentin versus clonidine tablet for better post operative pain relief and duration in lower abdomen surgery  
Scientific Title of Study   Comparison between oral gabapentin and oral clonidine premedication for post operative pain relief in patient undergoing lower abdomen surgery under spinal anaesthesia A 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  dr Revaanth E R 
Designation  Post graduate student 
Affiliation  Bangalore medical college and research institute 
Address  3rd floor, MPB building, Department of anaesthesia victoria hospital bangalore medical college and research institute, bengaluru.

Bangalore
KARNATAKA
560002
India 
Phone  9080537427  
Fax    
Email  revaanth1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  dr keerthi 
Designation  assistant professor 
Affiliation  Bangalore medical college and research institute 
Address  3rd floor, MPB building, Department of anaesthesia victoria hospital bangalore medical college and research institute, bengaluru.

Bangalore
KARNATAKA
560002
India 
Phone  9663870054  
Fax    
Email  Kanikekeerthi1438@gmail.com  
 
Details of Contact Person
Public Query
 
Name  dr ramachandraiah r 
Designation  professor 
Affiliation  Bangalore medical college and research institute 
Address  3rd floor, MPB building, Department of anaesthesia victoria hospital bangalore medical college and research institute, bengaluru.

Bangalore
KARNATAKA
560002
India 
Phone  9080537427  
Fax    
Email  ramachandraiah090@gmail.com  
 
Source of Monetary or Material Support  
Bangalore medical college and research institute Bangalore india 560002 
 
Primary Sponsor  
Name  dr revaanth E R 
Address  3rd floor, MPB building, Department of anaesthesia victoria hospital bangalore medical college and research institute, bengaluru. 
Type of Sponsor  Other [self] 
 
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 Revaanth E R  Bangalore medical college and research institute  3rd floor MPB building department of anaesthesia victoria hospital Bangalore medical college and research institute bangalore
Bangalore
KARNATAKA 
9080537427

revaanth1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore medical college and research institute  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 
Comparator Agent  ablet Clonidine 100 micro gram  Patient taken tablet orally 1 hour before administration of spinal anaesthesia with sips of water 
Intervention  tablet gabapentin 600 milli gram  Patient taken tablet orally 1 hour before administration of spinal anaesthesia with sips of water 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patient willing to give informed written consent
2 Adult normotensive patients aged between 18 to 60 years posted for surgery
3 American society of Anaesthesiology grade 1 or 2
 
 
ExclusionCriteria 
Details  1 Any contraindications for spinal anesthesia
2 Patients undergoing emergency surgical procedures
3 Patients on anti-hypertensives sedativies MAO-inhibitors tricyclic antidepressants opioids drugs Analgesic
4 Patients with neurological cardiac respiratory metabolic renal or hepatic disorders coagulation abnormalities
5 Patients has known allergy or hypersensitivity to drugs
6 Patient with history of pre-operative bradycardia hypotension Pregnant women psychiatric illness
7 Patients who refused to participate were excluded from the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of post operative Analgesia  2nd, 4th 6th 8th 12th 24th hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the duration of sensory and motor subarachnoid block
Assessment of sedation by Ramsay sedation score
To look for other side effects like Hypotension Bradycardia drowsiness dizziness Nausea and Vomiting
 
2nd, 4th 6th 8th 12th 24th hours 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   13/10/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Methodology

A pre-anesthetic checkup was conducted one day prior to surgery Detailed history and presenting complaints were noted followed by general and systemic examinations Routine laboratory investigations were performed All patients were instructed to remain nil per oral for solids for six hours prior to surgery Informed written consent was obtained after explaining the procedure During the preoperative visit and again in the preparation room the Visual Analog Scale VAS and Ramsay Sedation Score RSS were explained to all patients

In the preparation room standard monitors including electrocardiogram ECG non-invasive blood pressure NIBP and pulse oximetry were connected Baseline parameters such as heart rate HR systolic and diastolic blood pressure and peripheral oxygen saturation SpO2 were recorded An intravenous IV line was secured using an 18-gauge cannula

A total of 82 patients were randomized into two groups n 41 each using a computer-generated randomization table wwwrandomizationcom

Group C Clonidine group received tablet clonidine 100 µg orally 1 hour before administration of spinal anesthesia with sips of water
Group G Gabapentin group received tablet gabapentin 600 mg orally 1 hour before administration of spinal anesthesia with sips of water

Both the investigator and the patient were blinded to the group allocation The premedication was administered by nursing staff

In the operating room baseline vitals were again recorded Co-loading was done with Ringers lactate solution at 10 mlkg prior to spinal anesthesia Under aseptic precautions a lumbar puncture was performed at the L3-L4 interspace using a 26-gauge Quincke spinal needle via a midline approach in either the right or left lateral decubitus position Skin infiltration was done using 2 percent lignocaine A subarachnoid block was achieved using 3 ml of 05 percent hyperbaric bupivacaine

Immediately after drug administration the spinal needle was withdrawn and the patient was placed in the supine position The onset of sensory block up to the T10 dermatome was assessed bilaterally using loss of pinprick sensation with a short hypodermic needle The onset of motor block was defined when the Modified Bromage Score reached 3

Maintenance fluids were administered using Ringers lactate at 6 mlkgh Post-spinal anesthesia vital signs were recorded at 2 5 15 30 minutes and then at 1-hour intervals until the end of surgery Hypotension if encountered was managed with IV injection of mephentermine 6 mg

After surgery patients were shifted to the Post-Anesthesia Care Unit PACU where hemodynamic monitoring was continued

Assessment Parameters

Efficacy Parameters

  • Duration of Sensory Block Time from onset of sensory block to return of tactile sensation at L5 dermatome great toe

  • Duration of Motor Block Time from onset of motor block to the ability to lift both lower limbs

  • Duration of Analgesia Time from onset of sensory block to the administration of the first rescue analgesic

Pain was assessed using VAS at 2 4 6 8 12 and 24 hours postoperatively If VAS was greater than 3 injection diclofenac 1 mgkg IM was administered as rescue analgesia The time of first rescue analgesic dose was recorded by the attending nurse

Sedation was evaluated using the Ramsay Sedation Score RSS at 2 4 6 8 12 and 24 hours postoperatively

Safety Parameters

Side effects including dizziness bradycardia hypotension sedation drowsiness nausea and vomiting were monitored and treated as necessary These were assessed and scored by a blinded investigator


 
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