Smooth Extubation With Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary

Overview

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.

Full Title of Study: “Reliable and Rapid Smooth Extubation After Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary: A Randomized Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 12, 2020

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 ugkg and atracurium 0.5 mgkg. After tracheal intubation, general anesthesia maintained by isoflurane 1.5 volume % in 2 Lmin oxygen-air mixture 50:50 and atracurium 0.1 mgkg 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 0.01mgkg. 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.

Interventions

  • Drug: Ketofol as induction agent
    • Patients who received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia
  • Drug: Propofol as induction agent
    • Patients who received propofol (2mg/kg) only at the induction of general anesthesia.

Arms, Groups and Cohorts

  • Active Comparator: Group K
    • Ketofol group
  • Active Comparator: Group P
    • propofol group

Clinical Trial Outcome Measures

Primary Measures

  • smoothness of extubation
    • Time Frame: 5 minutes after extubation
    • Smoothness of extubation Grade Description No coughing on endotracheal tube Coughing on the tube Vomiting Laryngospasm

Secondary Measures

  • airway response to laryngoscopy and suction
    • Time Frame: 5 minutes after extubation
    • Grading of air way reflexes Grade Description Excellent(breathing well, no response to laryngoscopy& suctioning) Good(breathing well, minimal grimacing response to laryngoscope& suctioning) Satisfactory (breathing well coughing attempt to laryngoscopy& suctioning) Poor (breathing well, coughing on tube laryngoscopy) Very poor (breathing well, coughing on tube laryngoscopy)
  • sedation score
    • 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
  • Age
    • Time Frame: 6 hours before intervention
    • In years
  • weight
    • Time Frame: 6 hours before intervention
    • In kilograms
  • Height
    • Time Frame: 6 hours before intervention
    • In meters
  • BMI
    • Time Frame: 6 hours before intervention
    • In kilogram per square meter
  • mean arterial pressure (MAP)
    • Time Frame: 5 minutes before extubation
    • hemodynamic parameter
  • mean arterial pressure (MAP)
    • Time Frame: 1 minute after extubation
    • hemodynamic parameter
  • mean arterial pressure (MAP)
    • Time Frame: 5 minutes after extubation
    • hemodynamic parameter
  • mean arterial pressure (MAP)
    • Time Frame: 10 minutes after extubation
    • hemodynamic parameter
  • mean arterial pressure (MAP)
    • Time Frame: 15 minutes after extubation
    • hemodynamic parameter
  • mean arterial pressure (MAP)
    • Time Frame: 20 minutes after extubation
    • hemodynamic parameter
  • heart rate (HR)
    • Time Frame: 5 minutes before extubation
    • hemodynamic parameter
  • heart rate (HR)
    • Time Frame: 1 minute after extubation
    • hemodynamic parameter
  • heart rate (HR)
    • Time Frame: 5 minutes after extubation
    • hemodynamic parameter
  • heart rate (HR)
    • Time Frame: 10 minutes after extubation
    • hemodynamic parameter
  • heart rate (HR)
    • Time Frame: 15 minutes after extubation
    • hemodynamic parameter
  • heart rate (HR)
    • Time Frame: 20 minutes after extubation
    • hemodynamic parameter

Participating in This Clinical Trial

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.

Gender Eligibility: Female

patient with polycystic ovary.

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fayoum University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Atef Mohamed Sayed mahmoud, Lecturer – Fayoum University Hospital
  • Overall Official(s)
    • Atef S Khalil, MD, Principal Investigator, Fayoum University Hospitals

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