Efficacy of Ketamine versus Ketamine – Dexmedetomidine on effect site concentration of propofol target controlled infusion in short gynaecological procedures – Randomized Controlled Trial

The study will be conducted in the Department of Anesthesiology, Sri Manakula Vinayagar Medical College and Hospital, Puducherry. The study design will be a controlled triple blinded study. Preoperative examination will be done on patients posted for elective short gynaecological procedures with duration lasting 15-30 min to assess for eligibility based on inclusion and exclusion criteria. All eligible participants will be explained about the nature of the study and will be included in the study after obtaining written informed consent. Patient demographic data like age, height, weight, BMI will be recorded. Patients included in the study will be kept on NPO from 10.00 pm on the night prior to surgery and premedicated with T. Pantoprazole 40 mg on the day of surgery advised to be taken with sips of water two hours prior to the procedure. In the operation room, ASA monitors will be attached and baseline heart rate, non-invasive blood pressure, respiratory rate, end-tidal carbon dioxide and peripheral oxygen saturation will be recorded. A 20-G intravenous cannula will be inserted and checked for adequate flow. All patients will be administered oxygen by face mask at 6 L/min. BIS monitoring will be done for monitoring depth of Assessed for eligibility n=90 Allocated to Group A Patient receiving Ketamine with Propofol TCI n=45 Included in analysis n=45 Additional exclusion n=0 Allocated to to Group B Patient receiving Ketamine - Dexmedetomidine with Propofol TCI n = 45 Included in analysis n=45 Additional exclusion n=0 Randomised anesthesia. The study population will be randomly divided into 2 groups with 45 patients in each group. Group A – Patients receiving Ketamine with Propofol TCI Group B – Patients receiving Ketamine – Dexmedetomidine with Propofol TCI Patients will be administered Inj. Glycopyrrolate 5 mcg/kg, Inj. Ondansetron 0.1 mg/kg, Inj. Midazolam 0.02 mg/kg, Inj. Fentanyl 2 mcg/kg. An Anesthesiologist not related to study, administering anesthesia to the patient will prepare a 100 ml Normal saline solution based on the group the patient is allocated. For Group A, 0.5 ml of NS will be added to the 100 ml NS solution and given over 10 min prior to sedation. For Group B, 0.5 mcg/kg Dexmedetomidine will be added to the 100 ml NS solution and given over 10 min prior to sedation. Following which Inj. KETAMINE 0.75mg/kg will be given in both groups and started on Propofol target controlled infusion using Schnider model. The baseline effect site concentration will be set at 2.0 mcg/ml and the patient will be assessed every 3 min for BIS values and Modified Observer’s Alertness sedation scale. The procedure will be started once MOAA/S reaches 0 and if BIS reaches 50-60. A stable sedation with no patient movement and maintenance of airway, oxygenation and hemodynamics will be the primary goal intra-operatively. The TCI infusion of propofol will be titrated using modified Dixon’s up and down method with subsequent titrations done at 0.5 mcg/ml every 3 min. If there is no movement, the TCI effect site concentration will be reduced by 0.5 mcg/ml from the previous setting. If there is movement during the procedure, the procedure will be carried out after 3 min of increasing the effect site concentration by 0.5 mcg/ml from the previous setting. The MOAA/Score, BIS, Effect site concentration and plasma concentration of propofol will be recorded every 3 min. Vital parameters like HR, NIBP, SpO2, RR, ETCO2 will be monitored every 5 min. When there is no chest movement and ETCO2 tracing, it will be considered apnea and duration of apnea if more than 30 seconds will be recorded. When there is chest movement with no ETCO2 tracing, airway obstruction or laryngospasm will be suspected and airway maneuvers will be performed to maintain a patent airway. The requirement of airway maneuvers and the nature of the airway maneuvers or use of oropharyngeal or nasopharyngeal airway will be recorded. The incidence of laryngospasm or bronchospasm will also be noted. If oxygen saturation falls below 94% then bag and mask ventilation will be performed and it will be recorded. The TCI infusion will be stopped after completion of the procedure. Hypotension defined as MAP less than 60 mmHg or decrease in MAP less than 20% of baseline will be noted and treated with IVF bolus and inj. Ephedrine 6mg IV. Bradycardia defined as HR less than 50/min will be treated with Inj. Atropine 0.6 mg IV. The incidence of bradycardia and hypotension will be recorded. Postoperatively time taken for recovery, time interval between cessation of TCI propofol to MOAA/S of 5 when patients could respond readily to name spoken in normal tone will be recorded and the corresponding BIS and effect site concentration of propofol will be noted. The incidence of post-operative nausea, vomiting and emergence delirium will also be documented.