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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Smooth Extubation

Intervention / Treatment
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* Drug: Ketofol as induction agent
* Drug: Propofol as induction agent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketofol, Propofol, Laparoscopic Drilling of Polycystic Ovary