A Phase 4 interventional study of Ketofol as induction agent and Propofol as induction agent in Smooth Extubation, sponsored by Fayoum University Hospital. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-04-28.
Sponsored by Fayoum University Hospital · Phase 4, Interventional, and Prevention
the effect of ketofol, a combination of propofol and ketamine, on hemodynamics and airway response during induction of general anesthesia has been studied before. Its effect on the smoothness of extubation has not been studied before. In the present study; we aimed to assess the effect of ketofol on the smoothness of extubation as regards, airway response, sedation score during suction and extubation and hemodynamic changes comparing it with propofol for induction of general anesthesia.
After securing intravenous access by a 20g catheter, intravenous premedication (midazolam 2 mg and 4mg ondansetron) was administered to all patients. Standard ASA(american society of anesthesiologists) monitoring (5-lead ECG, noninvasive blood pressure (NIBP), and pulse oximetry) was applied to all the patients for the recording of heart rate (HR), NIBP and oxygen saturation by a multiparameter monitor. Induction of general anesthesia was achieved as follows: in Group K (Ketofol group), fifty three female patients received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia while in Group P (Propofol group), fifty three female patients received propofol (2mg/kg) only at the induction of general anesthesia.
Patients in both groups received fentanyl 2 ug\kg and atracurium 0.5 mg\kg. After tracheal intubation, general anesthesia maintained by isoflurane 1.5 volume % in 2 L\min oxygen-air mixture 50:50 and atracurium 0.1 mg\kg every 30 minutes, if needed. At the end of the surgery, inhalational anesthesia was stopped and reversal of the patients was done by injection of neostigmine 0.05mg\ kg and atropine 0.01mg\kg.
Hemodynamics (HR and mean arterial pressure ''MAP'') was assessed at 5 minutes interval from the time of reversal of muscle relaxant up to 30 minutes after extubation.
The level of sedation during suction and extubation was assessed using observer assessment sedation score and the airway response under direct laryngoscopy to suction was noted by five-point scale. After 5 minute interval, the level of sedation and smoothness of extubation was noted by four-point scale.
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Exclusion Criteria:
Ketofol group
Drug: Ketofol as induction agent
propofol group
Drug: Propofol as induction agent
Patients who received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia
Patients who received propofol (2mg/kg) only at the induction of general anesthesia.
smoothness of extubation
Smoothness of extubation Grade Description 1. No coughing on endotracheal tube 2. Coughing on the tube 3. Vomiting 4. Laryngospasm
Time frame: 5 minutes after extubation
airway response to laryngoscopy and suction
Grading of air way reflexes Grade Description 1. Excellent(breathing well, no response to laryngoscopy\& suctioning) 2. Good(breathing well, minimal grimacing response to laryngoscope\& suctioning) 3. Satisfactory (breathing well coughing attempt to laryngoscopy\& suctioning) 4. Poor (breathing well, coughing on tube laryngoscopy) 5. Very poor (breathing well, coughing on tube laryngoscopy)
Time frame: 5 minutes after extubation
sedation score
Observer assessment sedation score Observation Score Responds readily to name spoken in normal tone 5 Lethargic response to name spoken in normal tone 4 Responds only after name is called loudly and\\or repeatedly 3 Responds only after mild podding or shaking 2 Dose not responds to mild podding or shaking 1
Time frame: 5 minutes after extubation
Age
In years
Time frame: 6 hours before intervention
weight
In kilograms
Time frame: 6 hours before intervention
Height
In meters
Time frame: 6 hours before intervention
BMI
In kilogram per square meter
Time frame: 6 hours before intervention
mean arterial pressure (MAP)
hemodynamic parameter
Time frame: 5 minutes before extubation
mean arterial pressure (MAP)
hemodynamic parameter
Time frame: 1 minute after extubation
mean arterial pressure (MAP)
hemodynamic parameter
Time frame: 5 minutes after extubation
mean arterial pressure (MAP)
hemodynamic parameter
Time frame: 10 minutes after extubation
mean arterial pressure (MAP)
hemodynamic parameter
Time frame: 15 minutes after extubation
mean arterial pressure (MAP)
hemodynamic parameter
Time frame: 20 minutes after extubation
heart rate (HR)
hemodynamic parameter
Time frame: 5 minutes before extubation
heart rate (HR)
hemodynamic parameter
Time frame: 1 minute after extubation
heart rate (HR)
hemodynamic parameter
Time frame: 5 minutes after extubation
heart rate (HR)
hemodynamic parameter
Time frame: 10 minutes after extubation
heart rate (HR)
hemodynamic parameter
Time frame: 15 minutes after extubation
heart rate (HR)
hemodynamic parameter
Time frame: 20 minutes after extubation
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Fayoum University Hospital