| CTRI Number |
CTRI/2023/10/058395 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to identify the optimal preemptive analgesic dose of gabapentin |
|
Scientific Title of Study
|
Evaluation of two different doses of Gabapentin given as preemptive analgesia for Lumbar Laminectomy- A Randomized Double-Blind Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aswathi M P |
| Designation |
DNB Resident |
| Affiliation |
Lourdes hospital |
| Address |
Department of Anaesthesiology,
Lourdes hospital
Pachalam PO
Ernakulam
Ernakulam
KERALA
682012
India |
| Phone |
8848490015 |
| Fax |
|
| Email |
draswathimp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K A Koshy |
| Designation |
Senior consultant |
| Affiliation |
Lourdes hospital |
| Address |
Department of Anaesthesiology,
Lourdes hospital
Pachalam PO
Ernakulam
Ernakulam
KERALA
682012
India |
| Phone |
9446573477 |
| Fax |
|
| Email |
write2koshy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aswathi M P |
| Designation |
DNB Resident |
| Affiliation |
Lourdes hospital |
| Address |
Department of Anaesthesiology,
Lourdes hospital,
Pachalam PO
Ernakulam
Ernakulam
KERALA
682012
India |
| Phone |
8848490015 |
| Fax |
|
| Email |
draswathimp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lourdes hospital, Pachalam PO, Ernakulam,Kerala, PIN: 682012 |
|
|
Primary Sponsor
|
| Name |
Lourdes hospital |
| Address |
Lourdes hospital, Pachalam po, Ernakulam , Kerala, PIN: 682012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aswathi M P |
Lourdes hospital |
Department of Anaesthesiology, Pachalam PO, Ernakulam , Kerala, PIN: 682012
Ernakulam
KERALA |
8848490015
draswathimp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lourdes Hospital Ethics Committee |
Approved |
|
|
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 |
| Intervention |
Gabapentin |
300mg, oral, two hours preoperatively |
| Comparator Agent |
Gabapentin |
600mg, oral, two hours preoperatively |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA 1 and 2 patients undergoing elective lumbar laminectomy under general anesthesia |
|
| ExclusionCriteria |
| Details |
1) ASA 3 and 4
2) Pregnant and lactating patients
3) Patients on maintenance dose of gabapentin for any indication
4) Emergency surgery
5) Drug allergy to gabapentin or any common drugs that are used during general anesthesia
6) Prolonged surgery more than 4 hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Postoperative pain measured using Visual Analogue Scale
2) Consumption of rescue analgesic |
0,1,2,4,6,8,12,24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Modified Ramsay Sedation Score
2) Postoperative nausea and vomiting |
0,1,2,4,6,8,12,24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
16/10/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/08/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The present study is a randomized, double-blind, parallel group study to identify the optimal preemptive analgesic dose of gabapentin. I hypothesize that 300 mg of gabapentin is as effective efficacious as 600 mg of gabapentin for preemptive analgesia following lumbar laminectomy under general anesthesia. The primary outcomes to be measured are VAS score and consumption of rescue analgesic for the first 24 hours postoperatively. The secondary outcomes to be measured are Modified RSS and postoperative nausea and vomiting. |