| CTRI Number |
CTRI/2025/12/099481 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
To study the effects of oral Melatonin on pre operative Anxiety, Sedation and Induction dose of Thiopentone Sodium |
|
Scientific Title of Study
|
The effects of Oral Melatonin on pre operative Anxiety,Sedation and Induction dose of Thiopentone Sodium 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 center |
| Address |
Department of Anesthesia, Ground Floor OT complex, Sapthagiri Institute of Medical Sciences and Research Centre, Hesaraghatta Main Road,Chikkabanavara,Bangalore,Karnataka 560090
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 center |
| Address |
Department of Anaesthesia Ground Floor OT,Sapthagiri Institute of Medical Sciences and Research Centre, Hesaraghatta Main Road,Chikkabanavara,Bangalore,Karnataka 560090
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 center |
| Address |
Department of Anaesthesia, Ground Floor OT, Sapthagiri Institute of Medical Sciences and Research Centre, Hesaraghatta Main Road,Chikkabanavara,Bangalore,Karnataka 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
9880588325 |
| Fax |
|
| Email |
Shreyamurthy8993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia, Ground Floor OT Complex, Sapthagiri Institute of Medical sciences and Research Centre, Chikkabanawara, Banglore, Karnataka, India, 560090 |
|
|
Primary Sponsor
|
| Name |
Sapthagiri institute of medical sciences and research center |
| Address |
Department Of Anaesthesia, Ground Floor OT Complex, Sapthagiri Institute of Medical sciences and Research Centre, Chikkabanawara, Banglore, Karnataka, India, 560090 |
| 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 Centre |
Department of Anaesthesiology, Hesaraghatta Main road, Chikkabanavara, Bangalore,Karnataka, 560090
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 Centre |
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 3mg is given 1 hour before taking for surgery with sips of water and vitals noted at each 15minutes interval till induction |
| Intervention |
Oral Melatonin 3mg |
Oral Melatonin 3mg is given 1 hour before taking for surgery with sips of water and vitals noted at each 15 minutes interval till induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA 1 and 2
2) Patients undergoing elective surgeries under GA
3) Informed consent |
|
| ExclusionCriteria |
| Details |
1) Patients with difficult airway as assessed during PAC
2) Patients who have psychiatric,Neurological,Neuromuscular or Cardiovascular diseases or impairment of renal or hepatic functions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Oral Melatonin versus Placebo on induction dose of Thiopentone |
To compare the effect of Oral Melatonin versus Placebo on induction dose of Thiopentone, vitals noted every 15minutes till induction
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Oral Melatonin versus Placebo on pre operative Anxiety, Sedation in patients undergoing general anaesthesia using haemodynamic parameters, visual facial analogue score and Ramsay Sedation score respectively |
Haemodynamic parameters and Sedation score will be noted at the time of medication and after 15minutes till the loss of eyelash reflex |
|
|
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)
|
29/12/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
During the preoperative period anxiety is commonly seen in patients posted for surgery. An unpleasant state of tension or an uneasy feeling because of patients concern regarding the disease, hospital admission, anesthesia and surgery is described as preoperative-anxiety.It can lead to sympathetic stimulation and in some cases may lead to patient deferring surgery. may cause patients to avoid planned surgery.High levels of preoperative anxiety can have unfavorable effects on induction as well as maintenance of anaesthesia and lead to a delayed recovery from anaesthesia due to higher doses of induction agents and post operative analgesic drugs. An important goal in optimal anaesthetic management is to reduce the anxiety and this can be accomplished by good premedication. Preoperative anxiety can be reduced with certain pharmacological interventions. Benzodiazepines like midazolam is commonly used as a premedication to decrease the levels of anxiety. It has disadvantages like paradoxical reactions, variable bioavalibity, can interact with opioids and lead to a delay in discharge from the post anaesthesia care unit.
A naturally occurring neurohormone Melatonin(N-acetyl-5 methoxy tryptamine) is secreted in the human body by the pineal gland. Studies have shown that decrease in pre operative anxiety and sedation can be caused by melatonin without impairing orientation ,psychomotor skills and cognition which in turn improve the quality of recovery. It is a novel hypnotic with anaesthetic sparing effect and a wide safety margin in children a dose of 0.4 mg/kg has been used safely. As a result we designed this study to evaluate the effects of premedication with melatonin on preoperative anxiety and sedation. 2
Considering these facts, the present study is planned to assess the effects of melatonin on preoperative anxiolysis, sedation and induction dose of Thiopentone sodium. |