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

NCT ID: NCT03996213

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2019-10-31

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.

Conditions

Post-induction Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

supine group

induction of anesthesia will be initiated while patient in supine position

Group Type: NO_INTERVENTION

No interventions assigned to this group

head down

induction of anesthesia will be initiated while patient in head down position

Group Type: ACTIVE_COMPARATOR

head down position

Intervention Type: OTHER

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

leg elevation

induction of anesthesia will be initiated while patient in leg elevation position

Group Type: ACTIVE_COMPARATOR

leg elevation position

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hasanin

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Mohamed Hasanin

Cairo, , Egypt

Countries

Egypt

Central Contacts

Maha MA Mostafa, M.D

Role: CONTACT

maha.mostafa@cu.edu.eg

01000365115 ext. +2

References

Fakhari S, Bilehjani E, Farzin H, Pourfathi H, Chalabianlou M. The effect of passive leg-raising maneuver on hemodynamic stability during anesthesia induction for adult cardiac surgery. Integr Blood Press Control. 2018 Jun 7;11:57-63. doi: 10.2147/IBPC.S126514. eCollection 2018.

Reference Type: BACKGROUND

PMID: 29922085 (View on PubMed)

Geerts BF, van den Bergh L, Stijnen T, Aarts LP, Jansen JR. Comprehensive review: is it better to use the Trendelenburg position or passive leg raising for the initial treatment of hypovolemia? J Clin Anesth. 2012 Dec;24(8):668-74. doi: 10.1016/j.jclinane.2012.06.003.

Reference Type: BACKGROUND

PMID: 23228872 (View on PubMed)

Other Identifiers

N-116-2018

Identifier Type: -

Identifier Source: org_study_id