Smooth ExtubationPhase 4NCT04365686
Smooth Extubation With Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary
A Phase 4 study testing Ketofol as induction agent and Propofol as induction agent in people with Smooth Extubation, run by Fayoum University Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Smooth Extubation
- What is being tested?
- Ketofol as induction agent and Propofol as induction agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 20 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists Physical status ''ASA PS'' class I and II scheduled for laparoscopic drilling for polycystic ovary under general anesthesia.
Who cannot join
- from cardiac, hepatic, renal diseases, history of epilepsy
- Patient refusal.
- known drug allergy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fayoum University hospital
Al Fayyum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, 63514
About this study
Official title: Reliable and Rapid Smooth Extubation After Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary: A Randomized Controlled Trial.
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.
Read the 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.
- Conditions
- Smooth Extubation
- Being tested
- Ketofol as induction agent, Propofol as induction agent
- Keywords
- Ketofol, Propofol, Laparoscopic Drilling of Polycystic Ovary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketofol as induction agentDrug
Patients who received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia
Propofol as induction agentDrug
Patients who received propofol (2mg/kg) only at the induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group K | Active comparator | Ketofol group Receives: Drug: Ketofol as induction agent |
| Group P | Active comparator | propofol group Receives: Drug: Propofol as induction agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoothness of extubation
Smoothness of extubation Grade Description
- No coughing on endotracheal tube
- Coughing on the tube
- Vomiting
- Laryngospasm
Measured: 5 minutes after extubation
Secondary outcomes (18)
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)
Measured: 5 minutes after extubation
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
Measured: 5 minutes after extubation
Age
In years
Measured: 6 hours before intervention
weight
In kilograms
Measured: 6 hours before intervention
Height
In meters
Measured: 6 hours before intervention
BMI
In kilogram per square meter
Measured: 6 hours before intervention
mean arterial pressure (MAP)
hemodynamic parameter
Measured: 5 minutes before extubation
mean arterial pressure (MAP)
hemodynamic parameter
Measured: 1 minute after extubation
mean arterial pressure (MAP)
hemodynamic parameter
Measured: 5 minutes after extubation
mean arterial pressure (MAP)
hemodynamic parameter
Measured: 10 minutes after extubation
mean arterial pressure (MAP)
hemodynamic parameter
Measured: 15 minutes after extubation
mean arterial pressure (MAP)
hemodynamic parameter
Measured: 20 minutes after extubation
heart rate (HR)
hemodynamic parameter
Measured: 5 minutes before extubation
heart rate (HR)
hemodynamic parameter
Measured: 1 minute after extubation
heart rate (HR)
hemodynamic parameter
Measured: 5 minutes after extubation
heart rate (HR)
hemodynamic parameter
Measured: 10 minutes after extubation
heart rate (HR)
hemodynamic parameter
Measured: 15 minutes after extubation
heart rate (HR)
hemodynamic parameter
Measured: 20 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Apr 2019
- Primary completion12 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smooth ExtubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atef Mohamed Sayed mahmoud, Fayoum University Hospital
- Investigators
- Atef S Khalil, MD, Principal investigator, Fayoum University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365686
- Sponsor's protocol ID
- R83
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliable and Rapid Smooth Extubation After Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04365686
- Acronym / sponsor ID
- R83
- Conditions
- Smooth Extubation
- Keywords
- Ketofol, Propofol, Laparoscopic Drilling of Polycystic Ovary
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 12 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group K | Active comparator | Drug: Ketofol as induction agentKetofol group |
| Group P | Active comparator | Drug: Propofol as induction agentpropofol group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists Physical status ''ASA PS'' class I and II scheduled for laparoscopic drilling for polycystic ovary under general anesthesia.
Key exclusion criteria (3 listed)
- from cardiac, hepatic, renal diseases, history of epilepsy
- Patient refusal.
- known drug allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketofol as induction agentPatients who received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia | Drug | Group K |
| Propofol as induction agentPatients who received propofol (2mg/kg) only at the induction of general anesthesia. | Drug | Group P |
Primary outcome
smoothness of extubation
Time frame: 5 minutes after extubation
Smoothness of extubation Grade Description 1. No coughing on endotracheal tube 2. Coughing on the tube 3. Vomiting 4. Laryngospasm
18 secondary outcomes
airway response to laryngoscopy and suction
Time frame: 5 minutes after extubation
sedation score
Time frame: 5 minutes after extubation
Age
Time frame: 6 hours before intervention
weight
Time frame: 6 hours before intervention
Height
Time frame: 6 hours before intervention
BMI
Time frame: 6 hours before intervention
mean arterial pressure (MAP)
Time frame: 5 minutes before extubation
mean arterial pressure (MAP)
Time frame: 1 minute after extubation
mean arterial pressure (MAP)
Time frame: 5 minutes after extubation
mean arterial pressure (MAP)
Time frame: 10 minutes after extubation
mean arterial pressure (MAP)
Time frame: 15 minutes after extubation
mean arterial pressure (MAP)
Time frame: 20 minutes after extubation
heart rate (HR)
Time frame: 5 minutes before extubation
heart rate (HR)
Time frame: 1 minute after extubation
heart rate (HR)
Time frame: 5 minutes after extubation
heart rate (HR)
Time frame: 10 minutes after extubation
heart rate (HR)
Time frame: 15 minutes after extubation
heart rate (HR)
Time frame: 20 minutes after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
Related trials for Smooth Extubation
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
Not yet recruitingPhase 4
Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation
FESS Operation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atef S Khalil, MD principal investigator
Fayoum University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketofol as induction agent and Propofol as induction agent in people with Smooth Extubation, run by Fayoum University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
smoothness of extubation (time frame: 5 minutes after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.