Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651749
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-19
Brief Title:
Hemodynamic Effects of a High Dose Versus Low Dose Propofol During Induction of Anesthesia a Randomized Comparative Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Hemodynamic Effects of a High Dose Versus Low Dose Propofol During Induction of Anesthesia a Randomized Comparative Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators will test the hemodynamic effects of a high dose versus low dose Propofol during induction of anethesia
Detailed Description:
A Preoperative settings
In the anesthesia clinic an informed written consent will be obtained from every patient one day before the surgery All patients will be assessed preoperatively by careful history taking full physical examination and laboratory evaluation
B Intraoperative settings
On the arrival to operation room standerd ASA monitors will be attached automatic blood pressure measurements five-lead ECG monitor capnography and finger pulse oximetry will be applied The baseline value was measured
Measurement of mean arterial blood pressure by non-invasive blood pressure monitoringNIBP at selected time interval would be obtained as follows
baseline value NIBP systolic diastolic and mean value and HR 1 minute pre-injection
1 minute post injection
3 minutes post injection
5 minutes post injection
Final value 7 minutes post injection
We will calculate the percentage difference of lowest mean arterial blood pressure from baseline value using the following formula
Baseline mean blood pressure - lowest value mean blood pressure Baseline mean blood pressure
An intravenous infusion of ringer acetate 3mlkg will be started
Pre-oxygenation with 100 O2 on 8 Lmin for 3 min via face mask will be started
Induction of anesthesia would be done by using propofol dosage according to the group
1 Group LDP will receive 15mgkg propofol during induction of anesthesia
2 Group HDP will receive 25mgkg propofol during induction of anesthesia
In group LDP if the patient is still showing signs of awareness or intact eyelash reflex within two minutes post injection we will add 1mgkg propofol and the patient will be shifted to the HDP group
Fentanyl would be given during induction 2mickg IV
Atracurium besylate 05 mgkg IV will be given to facilitate tracheal intubation and anaesthesia will be maintained with 1 to 15 isoflurane
After orotracheal intubation mechanical ventilation will be started controlled mechanical ventilation will be achieved by tidal volumes of 8-10 mLKg and frequency of ventilation of up to 12-14 breathsmin to maintain normocapnia end-tidal pressure CO2 ET CO2 at the level of 35 5 mm Hg and Positive End Expiratory Pressure PEEP of 5-10 cm H2O
Supplemental boluses of Atracurium besylate 01 mgkg IV will be administered every 20 minutes to maintain muscle relaxation during surgery Anaesthesia will be maintained with isoflurane 1-15 to maintain the HR and MAP within 20 of pre-induction values andor Heart Rate HR 85 beats min during surgical stimulation
Regular automated monitoring NIBP systolic diastolic and mean value and HR 5minutes
At the end of the surgery each patient will be extubated upon meeting the extubation criteria
Intraoperatively any increase or decrease of HR hypotension or hypertension will be managed as required
If the patient sustains Bradycardia defined as HR 50 bpm for 3 minutes atropine 06 mgkg increments will be administered till acceptable response
If the patient sustains Hypotension defined as a decrease in systolic blood pressure 20-30 of baseline value for 3 minutes administration of ephedrine5-6 mg increments and fast intravenous fluid bolus 250 ml crystalloids
If the patient sustains Hypertension defined as an increase in systolic blood pressure 20-30 of baseline value for 3 minutes raising the end-tidal isoflurane concentration to 2 and 05 μgkg IV bolus of fentanyl will be administered till acceptable response after exclusion of causes other than sympathetic response to surgical stimulus
The whole study period will be attended and supervised by the most skilled person in the study group
cPostoperative settings The patients will be transferred to the post-anaesthesia care unit and will be put under observation
In the anesthesia clinic an informed written consent will be obtained from every patient one day before the surgery All patients will be assessed preoperatively by careful history taking full physical examination and laboratory evaluation
B Intraoperative settings
On the arrival to operation room standerd ASA monitors will be attached automatic blood pressure measurements five-lead ECG monitor capnography and finger pulse oximetry will be applied The baseline value was measured
Measurement of mean arterial blood pressure by non-invasive blood pressure monitoringNIBP at selected time interval would be obtained as follows
baseline value NIBP systolic diastolic and mean value and HR 1 minute pre-injection
1 minute post injection
3 minutes post injection
5 minutes post injection
Final value 7 minutes post injection
We will calculate the percentage difference of lowest mean arterial blood pressure from baseline value using the following formula
Baseline mean blood pressure - lowest value mean blood pressure Baseline mean blood pressure
An intravenous infusion of ringer acetate 3mlkg will be started
Pre-oxygenation with 100 O2 on 8 Lmin for 3 min via face mask will be started
Induction of anesthesia would be done by using propofol dosage according to the group
1 Group LDP will receive 15mgkg propofol during induction of anesthesia
2 Group HDP will receive 25mgkg propofol during induction of anesthesia
In group LDP if the patient is still showing signs of awareness or intact eyelash reflex within two minutes post injection we will add 1mgkg propofol and the patient will be shifted to the HDP group
Fentanyl would be given during induction 2mickg IV
Atracurium besylate 05 mgkg IV will be given to facilitate tracheal intubation and anaesthesia will be maintained with 1 to 15 isoflurane
After orotracheal intubation mechanical ventilation will be started controlled mechanical ventilation will be achieved by tidal volumes of 8-10 mLKg and frequency of ventilation of up to 12-14 breathsmin to maintain normocapnia end-tidal pressure CO2 ET CO2 at the level of 35 5 mm Hg and Positive End Expiratory Pressure PEEP of 5-10 cm H2O
Supplemental boluses of Atracurium besylate 01 mgkg IV will be administered every 20 minutes to maintain muscle relaxation during surgery Anaesthesia will be maintained with isoflurane 1-15 to maintain the HR and MAP within 20 of pre-induction values andor Heart Rate HR 85 beats min during surgical stimulation
Regular automated monitoring NIBP systolic diastolic and mean value and HR 5minutes
At the end of the surgery each patient will be extubated upon meeting the extubation criteria
Intraoperatively any increase or decrease of HR hypotension or hypertension will be managed as required
If the patient sustains Bradycardia defined as HR 50 bpm for 3 minutes atropine 06 mgkg increments will be administered till acceptable response
If the patient sustains Hypotension defined as a decrease in systolic blood pressure 20-30 of baseline value for 3 minutes administration of ephedrine5-6 mg increments and fast intravenous fluid bolus 250 ml crystalloids
If the patient sustains Hypertension defined as an increase in systolic blood pressure 20-30 of baseline value for 3 minutes raising the end-tidal isoflurane concentration to 2 and 05 μgkg IV bolus of fentanyl will be administered till acceptable response after exclusion of causes other than sympathetic response to surgical stimulus
The whole study period will be attended and supervised by the most skilled person in the study group
cPostoperative settings The patients will be transferred to the post-anaesthesia care unit and will be put under observation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None