CTRI Number |
CTRI/2018/02/012032 [Registered on: 21/02/2018] Trial Registered Prospectively |
Last Modified On: |
20/06/2018 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
comparing oral melatonin with oral clonidine as a drug given before anaesthesia, on anaesthetic usage and post operative pain in patients undergoing general anaesthesia |
Scientific Title of Study
|
Comparison of oral melatonin and clonidine as premedication on isoflurane consumption and postoperative analgesia in patients undergoing general anaesthesia– A randomised controlled trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ranjitha Gangadharaiah |
Designation |
Assistant professor |
Affiliation |
bangalore medical college and research institute |
Address |
bangalore medical college and research institute , department of anaesthesiology, centenery building 3rd floor, fort road, kr road
Bangalore KARNATAKA 560002 India |
Phone |
9880243626 |
Fax |
|
Email |
ranjithagangadharaiah@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ranjitha Gangadharaiah |
Designation |
Assistant professor |
Affiliation |
bangalore medical college and research institute |
Address |
bangalore medical college and research institute , department of anaesthesiology, centenery building 3rd floor, fort road, kr road
Bangalore KARNATAKA 560002 India |
Phone |
9880243626 |
Fax |
|
Email |
ranjithagangadharaiah@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ranjitha Gangadharaiah |
Designation |
Assistant professor |
Affiliation |
bangalore medical college and research institute |
Address |
bangalore medical college and research institute , department of anaesthesiology, centenery building 3rd floor, fort road, kr road
Bangalore KARNATAKA 560002 India |
Phone |
9880243626 |
Fax |
|
Email |
ranjithagangadharaiah@gmail.com |
|
Source of Monetary or Material Support
|
Dr Ranjitha Gangadharaiah, Bangalore medical college, department of anaesthesiology , centenery building, 3rd floor, fort road, kr road , bangalore 560002 |
|
Primary Sponsor
|
Name |
Dr Ranjitha Gangadharaiah |
Address |
Bangalore medical college and research institute , department of anaesthesiology, centenery building , 3rd floor, fort road, kr road, bangalore 560002 |
Type of Sponsor |
Government 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 |
Dr Ranjitha Gangadharaiah |
Bangalore medical College and research institute |
Department of anaesthesiology, centenery building,3rd floor,fort road, KR Road, Bangalore 560002 Bangalore KARNATAKA |
9880243626
ranjithagangadharaiah@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Bangalore medical college and research institute ethical committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
ASA 1 patients undergoing general anaesthesia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
melatonin and clonidine |
tab melatonin 3mg and tab clonidine 100microgram |
Comparator Agent |
melatonin, clonidine, control |
tab melatonin 3mg, clonidine 100microgram and placebo control group |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1) Patients who give written informed consent (Annexure I)
2) Patients belonging to ASA Grade I and II (Annexure II)
3) Age between 18-60 yrs
4) BMI between 18.9- 24.9 kg/m2
|
|
ExclusionCriteria |
Details |
1) Patient refusal
2) Patients with systemic disorders
3) Patients with psychiatric illness
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the effects of oral melatonin and clonidine as premedication on
1) isoflurane consumption
2) postoperative analgesia
|
Isoflurane consumption: every 30minutes till the end of surgery
Post operative analgesia: till the visual analogue scale is more than 5
|
|
Secondary Outcome
|
Outcome |
TimePoints |
to study the safety profile of melatonin and clonidine |
1 |
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
01/03/2018 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
08/06/2018 |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Although there are significant improvements in peri-operative pain management, fear and anxiety are still the major hurdles that prevent several patients from undergoing surgical interventions. There are many drugs used orally to reduce anxiety preoperatively like midazolam, clonidine, melatonin, gabapentin, etc . Midazolam is known to cause postoperative cognitive and pschycomotor impairment (1). Gabapentin causes nausea, vomiting and higher levels of sedation(2). Hence a drug without these side effects is preferred. Melatonin is a hormone secreted by the pineal gland(3). Melatonin exerts an effect on sleep by amplifying day/night differences in alertness and sleep quality. Melatonin has several functions that make it an attractive option for premedication including the regulation of circadian rhythm sedative, analgesic, anti inflammatory and antioxidant effects(4). Melatonin interacts with multiple receptor sites including opioidergic, benzodiazepinergic, muscarinic, nicotinic, serotonergic, α1, α2 adrenergic and most importantly MT1/MT2 melatonergic receptors present in the dorsal horn of the spinal cord as well in the central nervous system(5). Clonidine is an α-2 adrenoreceptor agonist which produces analgesia by its central action(6,7). It is rapidly absorbed after oral administration. It reaches a peak plasma concentration within 60-90mins. Clonidine stimulates alpha 2 adrenergic neurons in the medullary vasomotor centre causing a decrease in the sympathetic nervous system outflow from the Central nervous system to the peripheral tissues and central activation of non adrenergic imidazoline preferring receptors. Decreased sympathetic activity is manifested as peripheral vasodilatation, hypotension, decrease in heart rate and cardiac output. Some studies have proved that melatonin is an effective alternative to clonidine used in premedication especially in patients with low blood pressure. But they have used melatonin 5mg and clonidine 150µg (8). Some studies have shown that melatonin has similar efficacy compared to clonidine in reducing postoperative pain and narcotic consumption. Some studies have used 6mg of melatonin and 200 µg of clonidine (9) . There are some studies which have inferred that clonidine reduces the requirement of intraoperative isoflurane concentration (10) , but there are very few studies which have compared the anaesthetic consumption when melatonin or clonidine is given as premedication. Hence we have undertaken this study to compare the effects of oral melatonin 3mg and clonidine 100µg as premedication on isoflurane consumption and postoperative analgesia in patients undergoing GA. | |