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Completed

NCT Number: NCT04365686

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Fayoum University hospital

Al Fayyum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, 63514, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketofol as induction agent

Drug

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

Propofol as induction agent

Drug

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

Primary outcomes

  1. smoothness of extubation

    Time frame: 5 minutes after extubation

    Smoothness of extubation Grade Description

    • No coughing on endotracheal tube
    • Coughing on the tube
    • Vomiting
    • Laryngospasm

Secondary outcomes

  1. airway response to laryngoscopy and suction

    Time frame: 5 minutes after extubation

    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)
  2. sedation score

    Time frame: 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

  3. Age

    Time frame: 6 hours before intervention

    In years

  4. weight

    Time frame: 6 hours before intervention

    In kilograms

  5. Height

    Time frame: 6 hours before intervention

    In meters

  6. BMI

    Time frame: 6 hours before intervention

    In kilogram per square meter

  7. mean arterial pressure (MAP)

    Time frame: 5 minutes before extubation

    hemodynamic parameter

  8. mean arterial pressure (MAP)

    Time frame: 1 minute after extubation

    hemodynamic parameter

  9. mean arterial pressure (MAP)

    Time frame: 5 minutes after extubation

    hemodynamic parameter

  10. mean arterial pressure (MAP)

    Time frame: 10 minutes after extubation

    hemodynamic parameter

  11. mean arterial pressure (MAP)

    Time frame: 15 minutes after extubation

    hemodynamic parameter

  12. mean arterial pressure (MAP)

    Time frame: 20 minutes after extubation

    hemodynamic parameter

  13. heart rate (HR)

    Time frame: 5 minutes before extubation

    hemodynamic parameter

  14. heart rate (HR)

    Time frame: 1 minute after extubation

    hemodynamic parameter

  15. heart rate (HR)

    Time frame: 5 minutes after extubation

    hemodynamic parameter

  16. heart rate (HR)

    Time frame: 10 minutes after extubation

    hemodynamic parameter

  17. heart rate (HR)

    Time frame: 15 minutes after extubation

    hemodynamic parameter

  18. heart rate (HR)

    Time frame: 20 minutes after extubation

    hemodynamic parameter

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2020
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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