Does clonidine or melatonin reduce pain after brain tumour surgeries ?
Phase 3
- Conditions
- Health Condition 1: C719- Malignant neoplasm of brain, unspecifiedHealth Condition 2: C719- Malignant neoplasm of brain, unspecifiedHealth Condition 3: C719- Malignant neoplasm of brain, unspecifiedHealth Condition 4: C718- Malignant neoplasm of overlappingsites of brainHealth Condition 5: C718- Malignant neoplasm of overlappingsites of brain
- Registration Number
- CTRI/2023/09/057874
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 <br/ ><br> a) in 100 point VAS score postoperatively <br/ ><br> b) in fentanyl consumption in the postoperative period <br/ ><br> between melatonin versus clonidine as oral premedicants in craniotomies for supratentorial tumors. <br/ ><br>Timepoint: preoperative haemodynamics, <br/ ><br>intraoperative haemodynamics <br/ ><br>postoperative haemodynamics,VAS score 6, 12, 24 & 48 hours after extubation <br/ ><br>
- 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.Timepoint: preoperative haemodynamics, sedation score & anxiety score <br/ ><br>intraoperative haemodynamics <br/ ><br>postoperative haemodynamics and sedation score at 6, 12, 24 and 48 hours after extubation