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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04365686
Enrollment
106
Registered
2020-04-28
Start date
2019-04-01
Completion date
2020-04-20
Last updated
2020-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smooth Extubation

Keywords

Ketofol, Propofol, Laparoscopic Drilling of Polycystic Ovary

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.

Interventions

DRUGKetofol as induction agent

Patients who received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia

DRUGPropofol as induction agent

Patients who received propofol (2mg/kg) only at the induction of general anesthesia.

Sponsors

Fayoum University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
smoothness of extubation5 minutes after extubationSmoothness of extubation Grade Description 1. No coughing on endotracheal tube 2. Coughing on the tube 3. Vomiting 4. Laryngospasm

Secondary

MeasureTime frameDescription
sedation score5 minutes after extubationObserver 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
Age6 hours before interventionIn years
weight6 hours before interventionIn kilograms
airway response to laryngoscopy and suction5 minutes after extubationGrading 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)
BMI6 hours before interventionIn kilogram per square meter
mean arterial pressure (MAP)5 minutes before extubationhemodynamic parameter
heart rate (HR)5 minutes before extubationhemodynamic parameter
Height6 hours before interventionIn meters

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026