Fayoum University hospital
Al Fayyum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, 63514, Egypt
NCT Number: NCT04365686
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.
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Notify Me18 year–50 year
Female
Interventional
Phase 4
Al Fayyum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, 63514, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 5 minutes after extubation
Smoothness of extubation Grade Description
Time frame: 5 minutes after extubation
Grading of air way reflexes Grade Description
Time frame: 5 minutes after extubation
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: 6 hours before intervention
In years
Time frame: 6 hours before intervention
In kilograms
Time frame: 6 hours before intervention
In meters
Time frame: 6 hours before intervention
In kilogram per square meter
Time frame: 5 minutes before extubation
hemodynamic parameter
Time frame: 1 minute after extubation
hemodynamic parameter
Time frame: 5 minutes after extubation
hemodynamic parameter
Time frame: 10 minutes after extubation
hemodynamic parameter
Time frame: 15 minutes after extubation
hemodynamic parameter
Time frame: 20 minutes after extubation
hemodynamic parameter
Time frame: 5 minutes before extubation
hemodynamic parameter
Time frame: 1 minute after extubation
hemodynamic parameter
Time frame: 5 minutes after extubation
hemodynamic parameter
Time frame: 10 minutes after extubation
hemodynamic parameter
Time frame: 15 minutes after extubation
hemodynamic parameter
Time frame: 20 minutes after extubation
hemodynamic parameter
Fayoum University Hospital
Other
Reliable and Rapid Smooth Extubation After Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary: A Randomized Controlled Trial.
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