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

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ClinicalTrials.gov Identifier: NCT04365686
Recruitment Status : Completed
First Posted : April 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Atef Mohamed Sayed mahmoud, Fayoum University Hospital

Tracking Information
First Submitted Date  ICMJE April 23, 2020
First Posted Date  ICMJE April 28, 2020
Last Update Posted Date April 28, 2020
Actual Study Start Date  ICMJE April 1, 2019
Actual Primary Completion Date April 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
smoothness of extubation [ Time Frame: 5 minutes after extubation ]
Smoothness of extubation Grade Description
  1. No coughing on endotracheal tube
  2. Coughing on the tube
  3. Vomiting
  4. Laryngospasm
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
  • airway response to laryngoscopy and suction [ Time Frame: 5 minutes after extubation ]
    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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smooth Extubation With Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary
Official Title  ICMJE Reliable and Rapid Smooth Extubation After Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary: A Randomized Controlled Trial.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Smooth Extubation
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Group K
    Ketofol group
    Intervention: Drug: Ketofol as induction agent
  • Active Comparator: Group P
    propofol group
    Intervention: Drug: Propofol as induction agent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2020)
106
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 20, 2020
Actual Primary Completion Date April 12, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: patient with polycystic ovary.
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04365686
Other Study ID Numbers  ICMJE R83
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Atef Mohamed Sayed mahmoud, Fayoum University Hospital
Study Sponsor  ICMJE Fayoum University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Atef S Khalil, MD Fayoum University Hospitals
PRS Account Fayoum University Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP