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

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

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.

Study Overview

• Status: Completed
• Conditions: Smooth Extubation
• Intervention / Treatment: Drug: Ketofol as induction agent; Drug: Propofol as induction agent

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
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Madīnat Al Fayyūm, Faiyum Governorate, Egypt
    • Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, Egypt, 63514
      • Fayoum University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group K; Ketofol group	Drug: Ketofol as induction agent; Patients who received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia
Active Comparator: Group P; propofol group	Drug: Propofol as induction agent; Patients who received propofol (2mg/kg) only at the induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
airway response to laryngoscopy and suction	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)	5 minutes after extubation
sedation score	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	5 minutes after extubation
Age	In years	6 hours before intervention
weight	In kilograms	6 hours before intervention
Height	In meters	6 hours before intervention
BMI	In kilogram per square meter	6 hours before intervention
mean arterial pressure (MAP)	hemodynamic parameter	5 minutes before extubation
mean arterial pressure (MAP)	hemodynamic parameter	1 minute after extubation
mean arterial pressure (MAP)	hemodynamic parameter	5 minutes after extubation
mean arterial pressure (MAP)	hemodynamic parameter	10 minutes after extubation
mean arterial pressure (MAP)	hemodynamic parameter	15 minutes after extubation
mean arterial pressure (MAP)	hemodynamic parameter	20 minutes after extubation
heart rate (HR)	hemodynamic parameter	5 minutes before extubation
heart rate (HR)	hemodynamic parameter	1 minute after extubation
heart rate (HR)	hemodynamic parameter	5 minutes after extubation
heart rate (HR)	hemodynamic parameter	10 minutes after extubation
heart rate (HR)	hemodynamic parameter	15 minutes after extubation
heart rate (HR)	hemodynamic parameter	20 minutes after extubation

Collaborators and Investigators

• Sponsor: Fayoum University Hospital
• Investigators: Principal Investigator: Atef S Khalil, MD, Fayoum University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): April 12, 2020
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Propofol; Ketofol; Laparoscopic Drilling of Polycystic Ovary
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: R83

Drug and device information, study documents

• 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