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

Primary Purpose

Smooth Extubation

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ketofol as induction agent
Propofol as induction agent
Sponsored by
Fayoum University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smooth Extubation focused on measuring Ketofol, Propofol, Laparoscopic Drilling of Polycystic Ovary

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Fayoum University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group K

Group P

Arm Description

Ketofol group

propofol group

Outcomes

Primary Outcome Measures

smoothness of extubation
Smoothness of extubation Grade Description No coughing on endotracheal tube Coughing on the tube Vomiting Laryngospasm

Secondary Outcome Measures

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)
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
Age
In years
weight
In kilograms
Height
In meters
BMI
In kilogram per square meter
mean arterial pressure (MAP)
hemodynamic parameter
mean arterial pressure (MAP)
hemodynamic parameter
mean arterial pressure (MAP)
hemodynamic parameter
mean arterial pressure (MAP)
hemodynamic parameter
mean arterial pressure (MAP)
hemodynamic parameter
mean arterial pressure (MAP)
hemodynamic parameter
heart rate (HR)
hemodynamic parameter
heart rate (HR)
hemodynamic parameter
heart rate (HR)
hemodynamic parameter
heart rate (HR)
hemodynamic parameter
heart rate (HR)
hemodynamic parameter
heart rate (HR)
hemodynamic parameter

Full Information

First Posted
April 23, 2020
Last Updated
April 24, 2020
Sponsor
Fayoum University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04365686
Brief Title
Smooth Extubation With Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary
Official Title
Reliable and Rapid Smooth Extubation After Ketofol for Induction of General Anesthesia in Laparoscopic Drilling of Polycystic Ovary: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 12, 2020 (Actual)
Study Completion Date
April 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smooth Extubation
Keywords
Ketofol, Propofol, Laparoscopic Drilling of Polycystic Ovary

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group K
Arm Type
Active Comparator
Arm Description
Ketofol group
Arm Title
Group P
Arm Type
Active Comparator
Arm Description
propofol group
Intervention Type
Drug
Intervention Name(s)
Ketofol as induction agent
Intervention Description
Patients who received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol as induction agent
Intervention Description
Patients who received propofol (2mg/kg) only at the induction of general anesthesia.
Primary Outcome Measure Information:
Title
smoothness of extubation
Description
Smoothness of extubation Grade Description No coughing on endotracheal tube Coughing on the tube Vomiting Laryngospasm
Time Frame
5 minutes after extubation
Secondary Outcome Measure Information:
Title
airway response to laryngoscopy and suction
Description
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)
Time Frame
5 minutes after extubation
Title
sedation score
Description
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
Time Frame
5 minutes after extubation
Title
Age
Description
In years
Time Frame
6 hours before intervention
Title
weight
Description
In kilograms
Time Frame
6 hours before intervention
Title
Height
Description
In meters
Time Frame
6 hours before intervention
Title
BMI
Description
In kilogram per square meter
Time Frame
6 hours before intervention
Title
mean arterial pressure (MAP)
Description
hemodynamic parameter
Time Frame
5 minutes before extubation
Title
mean arterial pressure (MAP)
Description
hemodynamic parameter
Time Frame
1 minute after extubation
Title
mean arterial pressure (MAP)
Description
hemodynamic parameter
Time Frame
5 minutes after extubation
Title
mean arterial pressure (MAP)
Description
hemodynamic parameter
Time Frame
10 minutes after extubation
Title
mean arterial pressure (MAP)
Description
hemodynamic parameter
Time Frame
15 minutes after extubation
Title
mean arterial pressure (MAP)
Description
hemodynamic parameter
Time Frame
20 minutes after extubation
Title
heart rate (HR)
Description
hemodynamic parameter
Time Frame
5 minutes before extubation
Title
heart rate (HR)
Description
hemodynamic parameter
Time Frame
1 minute after extubation
Title
heart rate (HR)
Description
hemodynamic parameter
Time Frame
5 minutes after extubation
Title
heart rate (HR)
Description
hemodynamic parameter
Time Frame
10 minutes after extubation
Title
heart rate (HR)
Description
hemodynamic parameter
Time Frame
15 minutes after extubation
Title
heart rate (HR)
Description
hemodynamic parameter
Time Frame
20 minutes after extubation

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
patient with polycystic ovary.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atef S Khalil, MD
Organizational Affiliation
Fayoum University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fayoum University hospital
City
Fayoum
State/Province
Madīnat Al Fayyūm, Faiyum Governorate, Egypt
ZIP/Postal Code
63514
Country
Egypt

12. IPD Sharing Statement

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

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