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

Fayoum University Hospital

Status and phase: Completed; Phase 4

Conditions: Smooth Extubation

Treatments: Drug: Ketofol as induction agent; Drug: Propofol as induction agent

Study type: Interventional

Funder types: Other

Identifiers

NCT04365686

R83

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Group K

Active Comparator group

Description:

Ketofol group

Treatment:

Drug: Ketofol as induction agent

Group P

Active Comparator group

Description:

propofol group

Treatment:

Drug: Propofol as induction agent