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Does clonidine or melatonin reduce pain after brain tumour surgeries ?

Comparison of effect of preoperative melatonin and clonidine on postoperative pain in patients undergoing craniotomy for supratentorial tumours - a randomized controlled study - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057874
Enrollment
50
Registered
2023-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified Health Condition 2: C719- Malignant neoplasm of brain, unspecified Health Condition 3: C719- Malignant neoplasm of brain, unspecified Health Condition 4: C718- Malignant neoplasm of overlappingsites of brain Health Condition 5: C718- Malignant neoplasm of overlappingsites of brain

Interventions

Intervention1: Premedication given before induction of anaesthesia: Oral melatonin and clonidine given the night before and one hour before induction of anaesthesia-two oral doses given at two points

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 intraoperative haemodynamics postoperative haemodynamics and sedation score at 6, 12, 24 and 48 hours after extubation

Countries

India

Contacts

Public ContactSanghita Layek

Institute of Neurosciences Kolkata

bibhukalyanidas@gmail.com9836000519

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026