| CTRI Number |
CTRI/2023/01/049073 [Registered on: 18/01/2023] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
which drug reduces preoperative anxiety |
|
Scientific Title of Study
|
A comparative study of melatonin and gabapentin in reducing preoperative anxiety |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kelika Prakash |
| Designation |
Assistant Professor, |
| Affiliation |
Department of anaesthesiology AIIMS |
| Address |
Assistant Professor,
Department of anaesthesiology
AIIMS
South
DELHI
110029
India |
| Phone |
9540947117 |
| Fax |
|
| Email |
kelika.prakash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kelika Prakash |
| Designation |
Assistant Professor, |
| Affiliation |
Department of anaesthesiology AIIMS |
| Address |
Department of anaesthesiology
AIIMS
South
DELHI
110070
India |
| Phone |
09540947117 |
| Fax |
|
| Email |
kelika.prakash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kelika Prakash |
| Designation |
Assistant Professor, |
| Affiliation |
Department of anaesthesiology AIIMS |
| Address |
Department of anaesthesiology
AIIMS
South
DELHI
110070
India |
| Phone |
09540947117 |
| Fax |
|
| Email |
kelika.prakash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural fund, AIIMS new delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS New delhi |
| Address |
department of anaesthesiology
AIIMS, New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 |
| Kelika Prakash |
AIIMS, new delhi |
Room no 1, porta cabin, Department of anaesthesiology, pain and criticcal cre medicine
South
DELHI |
9540947117
kelika.prakash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gabapentin |
300 mg to be administerd30 minutes prio orally preoperatively 30 minutes prior to surgery
Duration of therapy : 30 minutes prior to surgery
|
| Intervention |
Melatonin |
melatonin tablet 6 mg to be swallowed Orally preoperatively 30 minutes prior to surgery
Duration of therapy: 30 minutes prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
PAtients undergoing routine surgery after trauma
ASA I and asa II patients |
|
| ExclusionCriteria |
| Details |
a) Patients for emergency surgeries
b) Surgeries taking place after 1pm (to account for diurnal variation in cortisol levels)
c) Patients having altered mental state, history of psychiatric disorder, history of drug abuse or those on chronic pain medication
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in the change in VAS anxiety score |
Difference in the change in VAS anxiety score at 90 minutes after drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in IL6 and serum cortisol levels |
90 minutes post drug administration |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/01/2023 |
| Date of Study Completion (India) |
20/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Reduction
in preoperative anxiety reduces postoperative pain, improves post surgery
recovery and even leads to early discharge. In addition providing analgesia
before the start of surgery(Preemptive analgesia) has been also been associated
with reduced postoperative pain. Patients suffering from trauma have high
stress levels making them it even more pertinent to tackle preoperative anxiety
and pain. Through this project we intend to find the appropriate premedication
which reduces preoperative anxiety and thereby reduces postoperative pain and
thus improves patient outcome.
Expected
Outcome: It is
expected that melatonin will be superior to alprazolam and gabapentin in
reducing preoperative anxiety as well as postoperative analgesic requirements. |