Comparison of the Hemodynamic Effect of Three Positions During Induction of Anesthesia
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|ClinicalTrials.gov Identifier: NCT03996213|
Recruitment Status : Not yet recruiting
First Posted : June 24, 2019
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post-induction Hypotension||Other: head down position Other: leg elevation position||Not Applicable|
Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and routine pre-medications (ranitidine 50 mg and midazolam 3-5 mg) will be administrated.
Before induction of anesthesia, patients will be randomly allocated into:supine group, head-down group or leg elevation group Baseline mean arterial blood pressure will be obtained as average of 3 reading before induction of anesthesia at supine position.
Induction of anesthesia will be achieved using fentanyl (2 mcg/Kg), propofol (2 mg/Kg), and atracurium (0.5 mg/Kg). Endotracheal tube will be inserted after 3 minutes of mask ventilation. Anesthesia will be maintained by isoflurane (1-1.5%) and atracurium 10 mg increments every 20 minutes. Ringer lactate solution will be infused at a rate of 2 mL/Kg/hour.
Any episode of hypotension (defined as mean arterial pressure < 80% of the baseline reading) will be managed by 5 mcg norepinephrine. If the hypotensive episode persisted for 2 minutes, another bolus of norepinephrine will be administered.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial Evaluating Head-down Position Versus Leg Elevation Position Versus Supine Position During Induction of General Anesthesia and Its Effect on the Incidence of Postinduction Hypotension|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
No Intervention: supine group
induction of anesthesia will be initiated while patient in supine position
Active Comparator: head down
induction of anesthesia will be initiated while patient in head down position
Other: head down position
Head-down position will be achieved by 30 degrees tilting of the whole operating table 1-minute before induction of anesthesia. The position will be maintained for 15 minutes after induction of anesthesia
Active Comparator: leg elevation
induction of anesthesia will be initiated while patient in leg elevation position
Other: leg elevation position
Leg elevation position will be achieved by raising the patient legs for 30 cm using two standard pillows positioned under the heels 1-minute before induction of anesthesia. The position will be maintained for 15 minutes after induction of anesthesia
- Incidence of post-induction hypotension [ Time Frame: during 15 minutes after induction of anesthesia ]mean arterial pressure < 80% of the baseline reading
- Incidence of severe post-induction hypotension [ Time Frame: during 15 minutes after induction of anesthesia ]defined as mean arterial pressure < 60% of the baseline reading
- Norepinephrine consumption [ Time Frame: during 15 minutes after induction of anesthesia ]mcg
- mean arterial pressure [ Time Frame: 1-minute intervals starting 1 minutes before induction of anesthesia till 15 minutes post-induction of anesthesia ]mmHg
- heart rate [ Time Frame: 1-minute intervals starting 1 minutes before induction of anesthesia till 15 minutes post-induction of anesthesia ]beat per minutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996213
|Contact: Maha MA Mostafa, M.D||01000365115 ext +email@example.com|
|Ahmed Mohamed Hasanin|
|Cairo, Egypt, 11432|