Clinical trial NCT04365686: Smooth Extubation With Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary
Official title: Reliable and Rapid Smooth Extubation After Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smooth Extubation
Keywords: Ketofol
Propofol
Laparoscopic Drilling of Polycystic Ovary
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 106
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Physical status ''ASA PS'' class I and II scheduled for laparoscopic drilling for polycystic ovary under general anesthesia.

Exclusion Criteria:

* from cardiac, hepatic, renal diseases, history of epilepsy
* Patient refusal.
* known drug allergy.

Primary outcomes:
measure: smoothness of extubation
timeFrame: 5 minutes after extubation
Secondary outcomes:
measure: airway response to laryngoscopy and suction
timeFrame: 5 minutes after extubation
measure: sedation score
timeFrame: 5 minutes after extubation
measure: Age
timeFrame: 6 hours before intervention
measure: weight
timeFrame: 6 hours before intervention
measure: Height
timeFrame: 6 hours before intervention
measure: BMI
timeFrame: 6 hours before intervention
measure: mean arterial pressure (MAP)
timeFrame: 5 minutes before extubation
measure: mean arterial pressure (MAP)
timeFrame: 1 minute after extubation
measure: mean arterial pressure (MAP)
timeFrame: 5 minutes after extubation
measure: mean arterial pressure (MAP)
timeFrame: 10 minutes after extubation
measure: mean arterial pressure (MAP)
timeFrame: 15 minutes after extubation
measure: mean arterial pressure (MAP)
timeFrame: 20 minutes after extubation
measure: heart rate (HR)
timeFrame: 5 minutes before extubation
measure: heart rate (HR)
timeFrame: 1 minute after extubation
measure: heart rate (HR)
timeFrame: 5 minutes after extubation
measure: heart rate (HR)
timeFrame: 10 minutes after extubation
measure: heart rate (HR)
timeFrame: 15 minutes after extubation
measure: heart rate (HR)
timeFrame: 20 minutes after extubation
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University hospital
state: Madīnat Al Fayyūm, Faiyum Governorate, Egypt
Study officials:
affiliation: Fayoum University Hospitals
name: Atef S Khalil, MD
role: PRINCIPAL_INVESTIGATOR
References: