A Comparative Study Of Demedetomidine - Ketamine Infusion Vs Dexmedetomidine Infusion For Post Operative Analgesia In Spine Surgeries A Prospective Double Blinded Randomised Control Trail.

After getting approval from the ethics committee, patients will be randomly allocated into 2 groups

via computer generated group of numbers.

Group A: Patients in group KD will be induced with ketodex (1 mg/kg of ketamine and 1 μg/kg of dexmedetomidine over 10 minutes) and propofol (1 mg/kg) and maintained with low-dose ketodex infusion (0.25 mg/kg/hr of ketamine and 0.3 μg/kg/hr of dexmedetomidine), O2/N2O, and Sevoflurane. Ketamine and dexmedetomidine will be administered simultaneously via two separate infusion pumps.

Group B:Patients in group D will be induced with dexmed (1 mcg/kg) followed by propofol 2 (mg/kg) and maintained with dexmedetomidine infusion (0.3 μg/kg/hr), O2/N2O, and sevoflurane. The patient will be intubated 4 minutes after administering vecuronium (0.1 mg/kg) when the TOF was zero. The patients will be positioned prone as per the planned procedure and the surgeon’s need.

 

Heart rate (HR), BP, ECG, SpO2, end-tidal carbon dioxide, BIS, TOF parameters, and temperature will be monitored intraoperatively. Intraoperative anesthesia will be maintained using sevoflurane in O2/N2O (1:1 mixture) to maintain a BIS of 40–60, and administration of vecuronium top-up (0.02 mg/kg) will be guided by the TOF. If BIS will be >60 and HR will be >20% of baseline, the sevoflurane concentration will be increased. If HR is >20% of baseline and the BIS is 40–60, 0.3 mcg/kg of Dexmedetomidine will be injected and the dose will be recorded. No additional non-opioid analgesics will be administered intraoperatively in either group.

  

The infusions will be continued until the application of the last skin suture. At this timepoint, the maintenance anaesthetic agent sevoflurane will be stopped. The residual neuromuscular blockade will be reversed with an injection of neostigmine (50 μg/kg) and glycopyrrolate (10 μg/kg) based on the TOF ratio of ≥0.6 and count of 4 and when the patient’s spontaneous breathing will be resumed. Before extubation, the anti-emetic agent ondansetron (0.1 mg/kg) will be administered. After extubation, the patients will be shifted to the post-anaesthesia care unit (PACU) for further monitoring.

Postoperatively, all patients will be administered injectable diclofenac (1.5 mg/kg) every 8 hours and the NRS scores will be recorded every 4 hours for 24 hours. An NRS score of 4 will be set as the threshold for tolerable postoperative pain. In patients complaining of intolerable pain (NRS >4), rescue analgesia will be administered {1 mcg/kg intravenous Fentanyl}. The time to the first rescue analgesia dose and perioperative analgesic requirements will be recorded and compared among the groups. “Postoperative opioid requirements” will be defined as the total rescue analgesic bolus doses administered in 24 hours.

The primary objective of the current study is to compare the postoperative opioid requirement for the first 24 hours after administration of intraoperative low-dose ketodex and dexmedetomidine infusion in patients undergoing thoracolumbar spine surgery. The secondary objectives is to compare the intraoperative anaesthetic requirements, postoperative pain scores, hemodynamic parameters, any side effects of study drugs and the duration of PACU stay among groups.