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

Phase 4

Completed

• Conditions: Smooth Extubation
• Interventions: Drug: Ketofol as induction agent; Drug: Propofol as induction agent

• Registration Number: NCT04365686
• Lead Sponsor: Fayoum University Hospital

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 Timeline

• Study Start: 2019-04-01
• Status Verified: 2020-04
• Primary Completion: 2020-04-12
• Study Completion: 2020-04-20
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-24
• Last Update Submitted: 2020-04-24
• Study First Posted: 2020-04-28
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group K	Ketofol as induction agent	Ketofol group
Group P	Propofol as induction agent	propofol group

Primary Outcome Measures

Name	Time	Method
smoothness of extubation	5 minutes after extubation	Smoothness of extubation Grade Description; 1. No coughing on endotracheal tube; 2. Coughing on the tube; 3. Vomiting; 4. Laryngospasm

Secondary Outcome Measures

Name	Time	Method
Age	6 hours before intervention	In years
weight	6 hours before intervention	In kilograms
Height	6 hours before intervention	In meters
BMI	6 hours before intervention	In kilogram per square meter
mean arterial pressure (MAP)	20 minutes after extubation	hemodynamic parameter
heart rate (HR)	20 minutes after extubation	hemodynamic parameter
airway response to laryngoscopy and suction	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	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

Trial Locations

Locations (1)

Fayoum University hospital; 🇪🇬 Fayoum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, Egypt