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

NCT03996213 | Unknown

• 1 other identifier: N-116-2018
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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

Conditions

Post-induction Hypotension

Outcome Measures

Primary Outcomes (1)

• Incidence of post-induction hypotension

  mean arterial pressure \< 80% of the baseline reading

  during 15 minutes after induction of anesthesia

Secondary Outcomes (4)

• Incidence of severe post-induction hypotension

  during 15 minutes after induction of anesthesia

• Norepinephrine consumption

  during 15 minutes after induction of anesthesia

• mean arterial pressure

  1-minute intervals starting 1 minutes before induction of anesthesia till 15 minutes post-induction of anesthesia

• heart rate

  1-minute intervals starting 1 minutes before induction of anesthesia till 15 minutes post-induction of anesthesia

Study Arms (3)

supine group

NO INTERVENTION

induction of anesthesia will be initiated while patient in supine position

head down

ACTIVE COMPARATOR

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

Other: head down position

leg elevation

ACTIVE COMPARATOR

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

Other: leg elevation position

Interventions

head down position 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

head down

leg elevation position 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

leg elevation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

Location

Related Publications (2)

• 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.

  PMID: 29922085 BACKGROUND

• 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.

  PMID: 23228872 BACKGROUND

MeSH Terms

Interventions

Head-Down Tilt

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Maha MA Mostafa, M.D

CONTACT

01000365115; maha.mostafa@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 21, 2019
• First Posted: June 24, 2019
• Study Start: July 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 25, 2019

Record last verified: 2019-06

Locations

EG (1)