Comparative study of intraoperative intravenous Ketamine and Dexmedetomidine on post-operative analgesia after Modified Radical Mastectomy.
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- post-op pain (by VAS score).
Study Overview
Brief Summary
The study will be conducted in Department of anesthesiology the IMS, BHU , Varanasi ,U.P, India after Institute Ethics Committee (IEC) approval and written informed consent from parents/guardian of patients. After CTRI registration 70 patients between 18 years to 60 years undergoing Modified Radical Mastectomy will be included according to inclusion and exclusion criteria. Patient will be randomly allocated into 2 groups according to random allocation sequence generated online.
GROUP K – Will be given IV Ketamine as loading dose of 0.5 mg/kg over 10 minutes followed by infusion of 0.3 mg/kg/hr.
GROUP D – Will be given IV Dexmedetomidine as a loading dose of 0.6microgm/kg over 10 minutes followed by maintenance infusion dose of 0.5microgm/kg/hr.
All patients will receive General Anaesthesia as per institutional protocol with Injection Midazolam 0.05mg/kg IV, Injection Fentanyl 2mcg/kg IV given before induction. The anaesthesia will be induced by Injection Propofol 1.5-2 mg/kg and tracheal intubation will be facilitated after Injection Vecuronium 0.1mg/kg after pre oxygenated with 100% oxygen for 3 minutes. Endotracheal tube will be connected to ventilator on the volume control mode with tidal volume of 6-8ml/kg and end tidal CO2 maintained between 35-45. Anaesthesia will be maintained by combination of Isoflurane, air, oxygen and intermittent Injection Vecuronium 0.01mg/kg. Injection Paracetamol 15mg/kg IV and Injection Tramadol 1mg/kg IV will be given to all cases in first hour of surgery and Injection Ondansetron 0.15 mg/kg IV 15 min prior to the reversal of neuromuscular blockade.
10 minutes before the completion of surgery, study drugs will be stopped and residual neuromuscular blockade will be reversed with Injection Neostigmine 0.05 mg/kg and Glycopyrrolate 0.01 mg/kg.
The trachea will be extubated after fulfilling extubation criteria and patient will be shifted to the post- anaesthetic care unit (PACU) where post-op monitoring of pain (by VAS score), sedation (by Ramsay sedation scale), postoperative nausea and/or vomiting, and complications (like hallucination, pruritus) will be done till 24hours after surgery. The Visual Analog Scale (VAS)will be monitored immediately in PACU and at 1hour, 2hours, 3hours, 4hours, 6hours, 8hours, 12hours, 18hours and 24 hours postoperatively.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Patients undergoing elective MRM surgery under General Anaesthesia.
- •Age Group 18 years to 60 year.
- •ASA Grade 1 or 2 physical state.
Exclusion Criteria
- •1.Planned post operative mechanical ventilation.
- •2.Planned regional anaesthesia/analgesia.
- •3.Perioperative Gabapentin, Magnesium use.
- •4.Pregnancy or breastfeeding.
- •5.Allergy to study medications.
- •6.H/O psychiatric disorder and substance abuse.
- •7.Significant preoperative hepatic dysfunction 8.Patient’s refusal.
Outcomes
Primary Outcomes
post-op pain (by VAS score).
Time Frame: 1hour, 2hours, 3hours, 4hours, 6hours, 8hours, 12hours, 18hours and 24 hours postoperatively
Secondary Outcomes
- sedation (by Ramsay sedation scale), postoperative nausea and/or vomiting(1hour, 2hours, 3hours, 4hours, 6hours, 8hours, 12hours, 18hours and 24 hours postoperatively)
Investigators
Dr Rajat Arora
Institute of Medical Sciences,BHU