| CTRI Number |
CTRI/2018/04/012960 [Registered on: 03/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of melatonin on anxiety and pain in patient undergoing eye surgery |
|
Scientific Title of Study
|
Effect of preoperative melatonin on anxiety and pain in patient undergoing Phacoemulsification cataract surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarala N |
| Designation |
Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Department of Pharmacology
Sri Devaraj Urs Medical College Sri Devaraj Urs Academy of Higher Education and Research Tamaka
Kolar
KARNATAKA
563102
India |
| Phone |
9845750165 |
| Fax |
08152243006 |
| Email |
n_sarala@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarala N |
| Designation |
Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Department of Pharmacology
Sri Devaraj Urs Medical College Sri Devaraj Urs Academy of Higher Education and Research Tamaka
Kolar
KARNATAKA
563102
India |
| Phone |
9845750165 |
| Fax |
08152243006 |
| Email |
n_sarala@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarala N |
| Designation |
Professor |
| Affiliation |
Sri Devaraj Urs Medical College |
| Address |
Department of Pharmacology
Sri Devaraj Urs Medical College Sri Devaraj Urs Academy of Higher Education and Research Tamaka
Kolar
KARNATAKA
563102
India |
| Phone |
9845750165 |
| Fax |
08152243006 |
| Email |
n_sarala@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar, Karnataka, India
PIN 563102 |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Sri Devaraj Urs Academy of Higher Education and Research, Tamaka, Kolar, Karnataka, India
PIN 563102 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Sarala N |
Sri Devaraj Urs Medical College |
Department of Pharmacology,1st Floor, College Building,
and
Department of Ophthalmology,1st Floor RLJalappa Hospital and Research Centre attached to Sri Devaraj Urs Medical College,
Sri Devaraj Urs Academy of Higher Education and Research Tamaka
Kolar
KARNATAKA |
9845750165
08152243006
n_sarala@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee, Sri Devaraj Urs Academy of Higher Education and Research, Kolar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cataract
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diazepam |
Tablet Diazepam 5mg orally 90 minutes before surgery |
| Intervention |
Melatonin |
Tablet melatonin 3mg orally 90 minutes before surgery |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients of either aged 50-80 years
2.Patients undergoing elective Phacoemulsification cataract surgery
3.Patients with American society of Anaesthesiologists (ASA) grade I-II
|
|
| ExclusionCriteria |
| Details |
1. Patients with sleep disorders, diabetes mellitus, depressive disorder, insufficient pupillary dilatation, nystagmus, deafness, allergy to study drugs, or expected compliance problems due to known psychiatric disease and epilepsy
2. Ongoing treatment with hypnotics, psychotropic drugs, non steroidal anti-inflammatory agents, beta blockers, coumarin derivatives and opioids within a week before admission
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in verbal anxiety score (VAS) , verbal pain score (VPS) and sedation score |
Before premedication (T1), 60 minutes after premedication (T2), during the operation period (T3) and also postoperatively before shifting them from the recovery room (T4). Sedation score will be assessed during performance of block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the adverse effects using WHO causality assessment scale
|
60 minutes after drug administration |
|
|
Target Sample Size
|
Total Sample Size="178"
Sample Size from India="178"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/02/2018 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
1.J Pharmacol Pharmacother. 2011 Oct;2(4):266-9. doi: 10.4103/0976-500X.85956.
2.J Postgrad Med. 2012 Apr-Jun;58(2):140-6. doi: 10.4103/0022-3859.97177. Review.
3.Ann Med Health Sci Res. 2014 May;4(3):320-4. doi: 10.4103/2141-9248.133452. Review
4.Food Chem Toxicol. 2011 Jan;49(1):248-50. doi: 10.1016/j.fct.2010.10.026. Epub 2010 Oct 29.
5.Biomed Res Int. 2017;2017:1327492. doi: 10.1155/2017/1327492. Epub 2017 Sep 26.
6.J Pain Res. 2017 Oct 16;10:2471-2477. doi: 10.2147/JPR.S144647. eCollection 2017.
7.Indian J Crit Care Med. 2015 Jul;19(7):384-7. doi: 10.4103/0972-5229.160274. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Need for the study Drugs such as propofol, benzodiazepines, opioids and dexmedetomedine have been used for sedation and pain during Phacoemulsification cataract surgery.1 Benzodiazepines are commonly used to alleviate anxiety but may impair psychomotor performance and suppress the duration of rapid eye movement sleep.2 Propofol and opioids cause sedation, disorientation and respiratory depression, dexmedetomedine may lead to hypotension, bradycardia and cardiovascular depression.3 In addition the cognitive function is impaired which is undesirable during cataract surgery, thus these limitations lead to impairment in patient’s co-operation during surgery. Therefore, the need for a drug that relieves anxiety and pain without causing cognitive dysfunction is desirable. Melatonin is secreted by the pineal gland in the dark and inhibited by exposure to light. Oral administration of 1–5 mg of melatonin results in plasma levels of 10–100 times more than the observed endogenous night-time levels.4 Melatonin has sedative, analgesic, antioxidative and anti-inflammatory property.5 Intraocular pressure (IOP) is higher during daytime than at night and it has been suggested that melatonergic mechanisms in the eyes could be responsible for the diurnal rhythm in IOP. Melatonin can cause adverse effects like drowsiness, headache, gastrointestinal disturbances and rash.6 It does not produce residual effects or suppression of rapid eye movement sleep. Melatonin 3-10mg oral has been approved by CDSCO for use in India on 12/03/1998 to treat sleep disorder, jet lag and regulation of circadian rhythm disorders.7 Few clinical studies have been carried out regarding the anxiolytic and analgesic effects of melatonin in the perioperative period. Hence this study will be carried out to evaluate the effects of melatonin premedication on anxiety, pain, sedation score and surgeon’s satisfaction in elective phacoemulsification cataract surgery. Objectives - To study the effect of melatonin on anxiety, pain and sedation using verbal anxiety score (VAS) , verbal pain score (VPS) and sedation score
- To assess the adverse effects using WHO causality assessment scale
|