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

Smooth Extubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365686
• Other study ID #: R83
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: April 20, 2020

Study information

• Verified date: April 2020
• Source: Fayoum University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 20, 2020
• Est. primary completion date: April 12, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• 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
• Propofol as induction agent
Patients who received propofol (2mg/kg) only at the induction of general anesthesia.

Locations

Country	Name	City	State
Egypt	Fayoum University hospital	Fayoum	Madinat Al Fayyum, Faiyum Governorate, Egypt

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoothness of extubation	Smoothness of extubation Grade Description; No coughing on endotracheal tube; Coughing on the tube; Vomiting; Laryngospasm	5 minutes after extubation
Secondary	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
Secondary	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
Secondary	Age	In years	6 hours before intervention
Secondary	weight	In kilograms	6 hours before intervention
Secondary	Height	In meters	6 hours before intervention
Secondary	BMI	In kilogram per square meter	6 hours before intervention
Secondary	mean arterial pressure (MAP)	hemodynamic parameter	5 minutes before extubation
Secondary	mean arterial pressure (MAP)	hemodynamic parameter	1 minute after extubation
Secondary	mean arterial pressure (MAP)	hemodynamic parameter	5 minutes after extubation
Secondary	mean arterial pressure (MAP)	hemodynamic parameter	10 minutes after extubation
Secondary	mean arterial pressure (MAP)	hemodynamic parameter	15 minutes after extubation
Secondary	mean arterial pressure (MAP)	hemodynamic parameter	20 minutes after extubation
Secondary	heart rate (HR)	hemodynamic parameter	5 minutes before extubation
Secondary	heart rate (HR)	hemodynamic parameter	1 minute after extubation
Secondary	heart rate (HR)	hemodynamic parameter	5 minutes after extubation
Secondary	heart rate (HR)	hemodynamic parameter	10 minutes after extubation
Secondary	heart rate (HR)	hemodynamic parameter	15 minutes after extubation
Secondary	heart rate (HR)	hemodynamic parameter	20 minutes after extubation