To study effectiveness of Drug Melatonin for pain after surgery, in patients of cancer of head and neck region.

Completed

• Conditions: 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,

• Registration Number: CTRI/2022/03/040841
• Lead Sponsor: All India Institute of Medical Sciences Rishikesh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-03
• Study Completion: 2023-02-14
• Last Update Posted: 2023-05-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• ASA I and II.
• Patient of either sex.
• Age: 18 years-65 years.
• Patients posted for head and neck oncological surgery.

Exclusion Criteria

• Refusal of patient or relatives.
• Severe uncontrolled systemic diseases (DM/HTN/CAD/Valvular heart disease/Respiratory disease/Neuromuscular disorders/Epilepsy).
• Allergy to study drug.
• Patients with a history of chronic use of sedatives or analgesics especially opioids or gabapentanoids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Perioperative haemodynamic changes.	Perioperative period.
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.
Neutrophil Lymphocyte Ratio score.	Before and after surgery.
Time to first analgesic requirement.	Postoperative period till 24 hours.

Trial Locations

Locations (1)

Department if Anesthesia, All India Institute of Medical Sciences, Rishikesh.; 🇮🇳 Dehradun, UTTARANCHAL, India

Department if Anesthesia, All India Institute of Medical Sciences, Rishikesh.

🇮🇳Dehradun, UTTARANCHAL, India

Jadhav Ramanand Vijayanand

Principal investigator

9021990449

Rvj4me@gmail.com