CDSCO Panel Seeks Anesthesiology Expert Review for AIIMS Raipur Trial on Gabapentin, Melatonin, Clonidine FDC
New Delhi: After reviewing a clinical trial proposal submitted by Dr Pratibha R Mudgal from AIIMS Raipur, involving a fixed-dose combination of Gabapentin 300 mg, Melatonin 3 mg, and Clonidine 100 µg, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has opined that the proposal be further deliberated with an expert from the field of anesthesiology before proceeding.
This came after the committee reviewed a clinical trial proposal submitted by Dr. Pratibha R. Mudgal from AIIMS Raipur, involving a fixed-dose combination of Gabapentin 300 mg, Melatonin 3 mg, and Clonidine 100 µg.
Gabapentin is an anticonvulsant medication used in the management of peripheral neuropathic pains, postherpetic neuralgia, and partial-onset seizures.
Melatonin is an endogenous hormone produced by the pineal gland that regulates sleep-wake cycles and, when provided exogenously, has beneficial effects on sleep-onset latency; it is available as an over-the-counter supplement.
Clonidine is an alpha-2 adrenergic agonist used to treat hypertension and severe cancer pain, among other conditions, and to treat withdrawal symptoms from various substances. It is also used to aid in the diagnosis of pheochromocytoma and to prevent migraines.
The committee noted that the proposed study population includes patients undergoing elective surgery requiring anesthesia with endotracheal intubation.
Considering the clinical context, the SEC recommended that the proposal be further deliberated with an expert from the field of anaesthesiology before proceeding.
