| CTRI Number |
CTRI/2025/09/094394 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
To see the effect of oral melatonin on Preoperative anxiety, sedation and induction dose of prpofol |
|
Scientific Title of Study
|
The Effects of Oral Melatonin on Preoperative Anxiety,Sedation and Induction Dose of Propofol in a Tertiary Care Centre.A Randomised Placebo Control 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 |
Dr Rajashekar Rama Poojari |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences, and Research Centre |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre,Anesthesia department,ground floor,Hesarghatta Main Road,Chikkabanavara,Bangalore
Sapthagiri Institute of Medical Sciences and Research Centre,Anesthesia department,ground floor,Hesarghatta Main Road,Chikkabanavara,Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
8073612347 |
| Fax |
|
| Email |
iamrajashekar74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreyavathi R |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre,Anaesthesia department,ground floor.Hesarghatta Main Road,Chikkabanavara,Bangalore
Sapthagiri Institute of Medical Sciences and Research Centre,Anaesthesia department,ground floor.Hesarghatta Main Road,Chikkabanavara,Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
9880588325 |
| Fax |
|
| Email |
shreyamurthy8993@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreyavathi R |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre,Anaesthesia department,ground floor.Hesarghatta Main Road,Chikkabanavara,Bangalore
Sapthagiri Institute of Medical Sciences and Research Centre,Anaesthesia department,ground floor.Hesarghatta Main Road,Chikkabanavara,Bangalore
Bangalore
KARNATAKA
560090
India |
| Phone |
9880588325 |
| Fax |
|
| Email |
shreyamurthy8993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute of Medical Sciences and Research Centre,Anaesthesia department,ground floor.Hesarghatta Main Road,Chikkabanavara,Bangalore |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical Sciences and Reserch Center |
| Address |
Hesarghatta Main Road, Chikkabanavara,Bangalore,560090Karnataka |
| 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 |
| Dr Rajashekar Rama Poojari |
Sapthagiri Institute Of Medical Sciences and Research Center |
Sapthagiri Institute of Medical Sciences and Research Centre,Hesarghatta Main Road,Chikkabanavara,Bangalore
Bangalore
KARNATAKA |
8073612347
iamrajashekar74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute Of Medical Sciences and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Multivitamin |
Oral multivitamin is given 1 hour before taking for surgery with sips of water |
| Intervention |
Oral Melatonin 3mg |
Oral Melatonin 3mg is given 1 hour before taking for surgery with sips of water and vitals noted at each 15minutes interval till induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1]ASA 1 & 2
2]Age 18yrs to 50 yrs of both sexes
3]Patients undergoing elective surgeries under GA
4]Informed consent |
|
| ExclusionCriteria |
| Details |
1]Patients with difficult airway as assessed during PAC
2]Patients who have psychiatric,Neurological,Neuromuscular or Cardiovascular diseases or impairement of renal or hepatic functions |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of oral Melatonin versus Placebo on induction dose of Propofol. |
To compare the effect of oral Melatonin versus Placebo on induction dose of Propofol , vitals noted every 15minutes till induction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of oral Melatonin versus Placebo on preoperative anxiety, sedation in patients undergoing general anaesthesia using hemodynamic parameter, visual facial analauge score & Ramsy sedation score respectively |
Hemodynamic parameters & sedation score will be noted at the time of medication & after every 15 minutes till at the time of loss of verbal response. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/09/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Anxiety is common in surgical patients during the preoperative period. Preoperative anxiety is described as an unpleasant state of uneasiness or tension that is secondary to a patient being concerned about a disease, hospitalization, anaesthesia and surgery, or the unknown. It may cause patients to avoid planned surgery. If anxiety is marked it causes all the signs of sympathetic stimulation and stress. High levels of preoperative anxiety have unfavourable effects on induction and maintenance of anaesthesia as well as on the recovery from anaesthesia and surgery. Anxious patients require higher doses of anaesthetic induction agents and postoperative analgesic drug. Hence the most important single reason for premedicating patients before surgery is to reduce anxiety. Reducing anxiety is an important goal in good anaesthesia management. Melatonin (N-acetyl-5-methoxytryptamine) is a hormone naturally produced in the brain, secreted by the pineal gland, whose receptors are found throughout the central nervous system and other body tissues. It is known to be an effective hormone in sleep disorders, anxiety, and pain, as well as an anti-inflammatory antioxidant, used as a premedication. A dose range of melatonin premedication is used to provide sedation and analgesia without cognitive impairment and psychomotor skills, and without any increase in recovery time. Several studies reported that melatonin has analgesic potential in addition to anxiolytic and sedative effects without disturbances of the cognitive and psychomotor skills and thus improves the quality of recovery.• Considering these facts, the present study is planned to assess the effects of melatonin on preoperative anxiolysis, sedation and induction dose of propofol. Its hypnotic and anesthetic sparing properties is studied by evaluating the induction dose of propofol |