Background
Postoperative pain is seen in upto 80% of patients despite using potent opioid analgesia during surgery. Unwanted side effects (nausea and vomiting, gastro-intestinal dysmotility, urinary retention, prolonged recovery, itching, postoperative sedation and respiratory depression) are likely, especially when opioids are used in high doses. Non-opioid analgesia with Dexmedetomidine has been shown to reduce anesthetic and opioid consumption in neurosurgical patients. Routine use of dexmedetomidine as a primary analgesic during brain surgery replacing opioids is currently limited by insufficient evidence, and low quality of previous studies due to small sample size. Hence, a large multi-centre randomized controlled trial is needed to establish the efficacy and safety of dexmedetomidine vis-à-vis opioids for pain management during and after brain surgery.
Purpose
The purpose of the current research project is to examine if intraoperative use of dexmedetomidine provides superior analgesia with reduced postoperative complications compared to fentanyl in patients undergoing neurosurgery for brain tumor.
Methods
In this multi-centric RCT, we will recruit consenting adult patients of either gender, between 18-65 years, undergoing elective brain tumor surgery. We will compare dexmedetomidine 0.5µg/kg/h with fentanyl 1µg/kg/h as the primary systemic analgesic during surgery. We will assess opioid consumption during the intraoperative period and postoperative pain along with other patient important short term and long term outcomes such as hemodynamics during surgery, anesthesia consumption, recovery characteristics after anesthesia and surgery, side effects of study drugs, sleep quality, patient satisfaction, and pain, neurological status, quality of life and return to activities at 3 and 6 months after surgery.
Funding
This multicentre research project is funded by the Department of Health Research, Indian Council of Medical Research, Government of India.
