| CTRI Number |
CTRI/2019/08/020502 [Registered on: 01/08/2019] Trial Registered Prospectively |
| Last Modified On: |
31/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study between oral melatonin and oral pregabalin on preoperative anxiety and perioperative sedation in surgeries under regional anaesthesia |
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Scientific Title of Study
|
Comparative study between oral melatonin and oral pregabalin on preoperative anxiety perioperative sedation and postoperative analgesia in surgeries under regional anaesthesia-A randomised control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anand S |
| Designation |
Proffessor |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Anaesthesia,
Chettinad Hospital and Research Institute,
Rajiv Gandhi Salai,
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7299589410 |
| Fax |
|
| Email |
dranandmurugan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Iris Eapen |
| Designation |
postgraduate student |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Anaesthesia,
Chettinad Hospital and Research Institute,
Rajiv Gandhi Salai,
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7299589410 |
| Fax |
|
| Email |
iris.eapen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Iris Eapen |
| Designation |
postgraduate student |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Anaesthesia,
Chettinad Hospital and Research Institute,
Rajiv Gandhi Salai,
Kelambakkam
Department of Anaesthesia,
Chettinad Hospital and Research Institute,
Rajiv Gandhi Salai,
Kelambakkam
Coimbatore
TAMIL NADU
603103
India |
| Phone |
7299589410 |
| Fax |
|
| Email |
iris.eapen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute
Rajiv Gandhi Salai,Kelambakkam
Kanchipuram Dist. TN 603103 |
|
|
Primary Sponsor
|
| Name |
Chettinad Hospital and Research Institute |
| Address |
Rajiv Gandhi Salai,Kelambakkam
Kanchipuram Dist. TN 603103 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Iris Eapen |
Chettinad Hospital and Research Institute |
OT complex,D block
Department of Anesthesiology and Critical Care
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai,Kelambakkam
Kanchipuram Dist. TN 603103
Kancheepuram
TAMIL NADU |
7299589410
iris.eapen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chettinad Academy and Research Education - Institutional Human Ethics Comittee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R451||Restlessness and agitation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
preanaesthetic medication |
T.Melatonin 6mg per oral,1hour prior to surgery |
| Comparator Agent |
preanaesthetic medication |
T.Pregabalin 300mg per oral, 1hour prior to surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-American Society of Anaesthesiologists(ASA) grade I-II
-BMI<30 kg/m2
-patients scheduled for surgery under sub arachnoid block |
|
| ExclusionCriteria |
| Details |
-pregnant patients
-mentally impaired patients,those with history of psychiatric orders,or on any antipsychotic drug intake,sleep disorders and inability to read and write basic alphabets and numbers were excluded from study |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
-Preoperative Anxiolysis
|
-Before giving the study drug -1 hour after giving study drug |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Sedation Score |
-Before giving study drug
-1 hour after giving study drug
-During surgery(0 minute,5minutes,10minutes,15 minutes,20minutes,30minutes,40minutes,50minutes,60minutes,70minutes,80minutes,90minutes)
-End of surgery |
| Orientation Score |
-Before giving study drug
-1 hour after giving study drug |
| Time Taken for TMT A and B |
-Before giving study drug
-1 hour after giving study drug |
| Time taken for first request for post operative analgesia |
Time taken for first request for post operative analgesia |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
05/08/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Comparitive study between oral melatonin and oral pregabalin on preoperative anxiety and perioperative sedation in surgeries under sub arachnoid block
AIM To compare oral Melatonin(6mg) with oral Pregabalin(300mg) as preoperative anxiolytic, sedative and as a peri-operative analgesic in patients undergoing surgery under sub arachnoid block.
OBJECTIVES To compare the anxiolysis in both groups To compare the sedation score between both groups To compare the psychomotor and cognitive function between both groups To compare the need for post operative analgesia in both groups To compare the incidence of any side-effects associated
MATERIALS & METHODS
STUDY DESIGN:
Prospective, Randomized, Double blinded study.
SAMPLE SIZE: Kurdi M et al., (2015) Ghai A et al.,(2012) Sample size calculation for superiority trial with 80% power, alpha error of 0.05%,95% confidence interval. Total = 64 Patients
Group I Melatonin~ n = 32 Group II Pregabalin~ n = 32 Patients will be assigned to the respective groups based on a computer generated code
INCLUSION CRITERIA: American Society of Anaesthesiologists (ASA) grade I-II Age 18-60 years BMI<30 kg/m2 Patients scheduled for surgery under subarachnoid block
EXCLUSION CRITERIA: Pregnant patients Mentally Impaired patients, those with history of psychiatric disorders, or on any antipsychotic drug intake, sleep disorders and inability to read and write basic alphabets and numbers were excluded from the study
All the patients will undergo preoperative assessment in the preanesthetic assessment clinic. They will be advised fasting of eight hours for solid diet & 2 hours for oral clear fluids prior to surgery. They will also be explained about the visual analog scale (VAS) anxiety score and trail making test(TMT) A and B.
The patient will be assessed for orientation,sedation and anxiety with an oritntation score,the ramsay sedation score and the VAS respectively alongwith the TMT-A and B prior to administering the study drug.The same assessment will be repeated 60 minutes after giving the study drug
The regional anesthesia that will be given is spinal anesthesia in sitting up postion,using a 26G or 27G Quincke needle to administer 3.5ml of plain 0.5% heavy bupivacaine in the L3-L4 space or the L2-L3 space.Vitals will be noted for every 2 minutes for the first 5 minutes,then every 5minutes till 20 minutes post anaesthesia and then evry 10 minutes till the end of surgery. Post surgery we will also note the time when the patient first requests for analgesia. Adverse effects if any that occur will be reported to the Ethics Committee and appropriate treatment will be given as required. After decoding of the randomized code, the collected data will be presented as a mean +/- standard deviation, and percentages as appropriate. Categorical variables will be analyzed using Chi-square test and appropriate continuous variables will be tested using Student’s t-test.
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