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

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

Tracking Information

• First Submitted Date: April 23, 2020
• First Posted Date: April 28, 2020
• Last Update Posted Date: April 28, 2020
• Actual Study Start Date: April 1, 2019
• Actual Primary Completion Date: April 12, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Smooth Extubation

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 24, 2020): 106
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 20, 2020
• Actual Primary Completion Date: April 12, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: patient with polycystic ovary.

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04365686
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Atef Mohamed Sayed mahmoud, Fayoum University Hospital
• Study Sponsor: Fayoum University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Atef S Khalil, MD; Fayoum University Hospitals

• PRS Account: Fayoum University Hospital
• Verification Date: April 2020