| CTRI Number |
CTRI/2022/03/040841 [Registered on: 04/03/2022] Trial Registered Prospectively |
| Last Modified On: |
13/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study effectiveness of Drug Melatonin for pain after surgery, in patients of cancer of head and neck region. |
|
Scientific Title of Study
|
Efficacy of Melatonin on post operative pain reduction in patients undergoing Head and Neck cancer surgery under General Anaesthesia- Prospective Randomized double blind controlled study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajit Kumar |
| Designation |
Additional Professor. |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh. |
| Address |
Department of Anesthesia, All India Institute of Medical Sciences Rishikesh.
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9910789377 |
| Fax |
|
| Email |
Ajitdr.ajit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajit Kumar |
| Designation |
Additional Professor. |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh. |
| Address |
Department of Anesthesia, All India Institute of Medical Sciences Rishikesh.
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9910789377 |
| Fax |
|
| Email |
Ajitdr.ajit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajit Kumar |
| Designation |
Additional Professor. |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh. |
| Address |
Department of Anesthesia, All India Institute of Medical Sciences, Rishikesh.
Dehradun
UTTARANCHAL
249201
India |
| Phone |
9910789377 |
| Fax |
|
| Email |
Ajitdr.ajit@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
Virbhadra Road, Sturida Colony, Rishikesh, Uttarakhand. PIN 249201. |
| Type of Sponsor |
Government 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 |
| Jadhav Ramanand Vijayanand |
Department if Anesthesia, All India Institute of Medical Sciences, Rishikesh. |
Virbhadra Road Sturida colony Rishikesh. Pin 249201.
Dehradun
UTTARANCHAL |
9021990449
Rvj4me@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Rishikesh. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (2) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (3) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (4) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (5) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (6) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (7) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Tablet Melatonin 9mg. |
Oral Tablet Melatonin 9mg, in evening of day before surgery and on morning of surgery |
| Comparator Agent |
Placebo |
Oral placebo Tablet, in evening of day before surgery and on morning of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA I and II.
2. Patient of either sex.
3. Age: 18 years-65 years.
4. Patients posted for head and neck oncological surgery. |
|
| ExclusionCriteria |
| Details |
1. Refusal of patient or relatives.
2. Severe uncontrolled systemic diseases (DM/HTN/CAD/Valvular heart
disease/Respiratory disease/Neuromuscular disorders/Epilepsy).
3. Allergy to study drug.
4. Patients with a history of chronic use of sedatives or analgesics especially opioids
or gabapentanoids. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative pain score (VAS score) up to 24 hours after surgery between melatonin and control group. |
At the End of surgery, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours after end of surgery |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Preoperative anxiety score. |
Before start of surgery. |
| Sedation score. |
At the End of surgery, 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours, 6 hours, 12 hours, 18 hours, 24 hours after end of surgery. |
| Perioperative haemodynamic changes. |
Perioperative period. |
| Time to first analgesic requirement. |
Postoperative period till 24 hours. |
| Neutrophil Lymphocyte Ratio score. |
Before and after surgery. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2022 |
| Date of Study Completion (India) |
14/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain is defined as “An unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage.†Over the past years, definition of pain has become multidimensional, as it is considered to be not just a sensation, but has also been described by several features such as quality perception, location, intensity, emotional impact and frequency. Melatonin is a neurohormone secreted by the pineal gland; it helps to maintain circadian rhythm of sleep cycle. It has been and is being used in many clinical trials with diffe rent therapeutic approaches. It has sedative, analgesic, anti chronobiotic effects. Present study plans evaluate the efficacy of preoperative Melatonin on post operative pain reduction and preoperative anxiety reduction in patients undergoing Head and Neck cancer surgery under General Anaesthesia. |