Comparison of the Hemodynamic Effect of Three Positions During Induction of Anesthesia

Not Applicable

• Conditions: Post-induction Hypotension
• Interventions: Other: leg elevation position; Other: head down position

• Registration Number: NCT03996213
• Lead Sponsor: Cairo University

Brief Summary

The most common methods for prevention of post-induction hypotension are preoperative fluid loading and vasopressors. Leg elevation induces an intrinsic transfusion of 150 mL blood from the lower limbs to the central fluid compartment. Leg elevation was previously reported by our group to decrease the incidence of maternal hypotension after spinal anesthesia for caesarean delivery. Passive leg raising was also reported to provide a stable hemodynamic profile during induction of anesthesia for cardiac surgery. Head-down position was previously reported as a useful measure for management of hypovolemia in various patient groups. No studies to the best of our knowledge had evaluated the compare both positions (leg elevation position and head-down position) during induction of anesthesia in non-cardiac surgery

Detailed Description

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 Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Last Update Submitted: 2019-06-22
• Study First Posted: 2019-06-24
• Last Update Posted: 2019-06-25
• Study Start: 2019-07
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• adult patients (18-60 years), american society of anesthesiologist physical status I-II, scheduled for elective non-cardiac surgery under general anesthesia

Exclusion Criteria

• Patients with cardiac morbidities (impaired contractility with ejection fraction < 50%, heart block, arrhythmias, tight valvular lesions), patients on antihypertensive medications, and patients with uncontrolled hypertension will be excluded from the study. Patient with decompensated respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation < 90% on room air), patients at increased risk of aspiration (Inadequate fasting time, chronic renal failure, diabetes mellitus, BMI≥40 kg/m2, Gastroesophageal reflux disease, Gastrointestinal obstruction, Previous upper gastrointestinal surgery and/or undergoing Upper gastrointestinal surgery), pregnant patients and patients with increased intracranial tension will be also excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
leg elevation	leg elevation position	induction of anesthesia will be initiated while patient in leg elevation position
head down	head down position	induction of anesthesia will be initiated while patient in head down position

Primary Outcome Measures

Name	Time	Method
Incidence of post-induction hypotension	during 15 minutes after induction of anesthesia	mean arterial pressure \< 80% of the baseline reading

Secondary Outcome Measures

Name	Time	Method
Incidence of severe post-induction hypotension	during 15 minutes after induction of anesthesia	defined as mean arterial pressure \< 60% of the baseline reading
heart rate	1-minute intervals starting 1 minutes before induction of anesthesia till 15 minutes post-induction of anesthesia	beat per minutes
Norepinephrine consumption	during 15 minutes after induction of anesthesia	mcg
mean arterial pressure	1-minute intervals starting 1 minutes before induction of anesthesia till 15 minutes post-induction of anesthesia	mmHg

Trial Locations

Locations (1)

Ahmed Mohamed Hasanin; 🇪🇬 Cairo, Egypt