| 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 |
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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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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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