Does clonidine or melatonin reduce pain after brain tumour surgeries ?

Phase 3

Not yet recruiting

• Conditions: Malignant neoplasm of brain, unspecified, (2) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (3) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, (4) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain, (5) ICD-10 Condition: C718||Malignant neoplasm of overlappingsites of brain,

• Registration Number: CTRI/2023/09/057874

Brief Summary

The incidence, magnitude and duration of acute pain experienced by neurosurgical patients after various brain operations are not known precisely. Postoperative pain was more common than generally assumed (60%). In two-thirds of the patients with postoperative pain, the intensity was moderate to severe. Pain most frequently occurred within the first 48 hours after surgery. Patients with high levels of preoperative anxiety require higher doses of anaesthetic induction agents and recover poorly. Preoperative anxiety and perioperative pain may be associated with each other. Preoperative anxiety serves a critical role in the chain of events that control the postoperative pain response. High level of preoperative anxiety is associated with an increased requirement of analgesics in the postoperative period. Postoperative pain management is an unorganized sphere owing to the dearth of standard analgesic protocols. In this study, we will give oral melatonin and oral clonidine as premedications the night before surgery and one hour before surgery. The primary objective is to assess difference in 100 point VAS score postoperatively and in fentanyl consumption in the postoperative period between melatonin versus clonidine in craniotomies for supratentorial tumours. The secondary objective is to compare perioperative anxiety, sedation, haemodynamic stability and adverse effects between the two groups.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-19
• Study Start: 2023-09-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients having Karnofsky performance score 80-100 Patients with intact higher mental functions Patients scheduled for elective craniotomies for supratentorial tumors Patients who have signed informed consent form.

Exclusion Criteria

Patients with hypersensitivity to any drug History of congestive heart failure, valvular heart disease History of renal or hepatic disease History of neuropsychiatric disorders Pregnant patients Patients on beta blockers, anti platelet drugs, anticoagulants, extended release formulation of any analgesic or any psychotropic drugs in the present or in the past Patients not getting extubated immediately after surgery Duration of surgery more than 4 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The primary objective is to assess difference	preoperative haemodynamics, | intraoperative haemodynamics | postoperative haemodynamics,VAS score 6, 12, 24 & 48 hours after extubation
a) in 100 point VAS score postoperatively	preoperative haemodynamics, | intraoperative haemodynamics | postoperative haemodynamics,VAS score 6, 12, 24 & 48 hours after extubation
b) in fentanyl consumption in the postoperative period	preoperative haemodynamics, | intraoperative haemodynamics | postoperative haemodynamics,VAS score 6, 12, 24 & 48 hours after extubation
between melatonin versus clonidine as oral premedicants in craniotomies for supratentorial tumors.	preoperative haemodynamics, | intraoperative haemodynamics | postoperative haemodynamics,VAS score 6, 12, 24 & 48 hours after extubation

Secondary Outcome Measures

Name	Time	Method
2.Comparison in perioperative state a) anxiety & sedation b) haemodynamic stability and c) adverse effects between the two groups.	preoperative haemodynamics, sedation score & anxiety score

Trial Locations

Locations (1)

Institute of Neurosciences Kolkata , 185, Acharya Jagadish Chandra Bose Road, Elgin; 🇮🇳 Kolkata, WEST BENGAL, India

Institute of Neurosciences Kolkata , 185, Acharya Jagadish Chandra Bose Road, Elgin

🇮🇳Kolkata, WEST BENGAL, India

Dr Sanghita Layek

Principal investigator

8145780194

sanghita.layek@gmail.com