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

• ClinicalTrials.gov Identifier: NCT03996213
• Recruitment Status: Not yet recruiting
• First Posted: June 24, 2019
• Last Update Posted: June 25, 2019
• Sponsor: Cairo University
• Information provided by (Responsible Party): Ahmed Hasanin, Cairo University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Post-induction Hypotension	Other: head down position; Other: leg elevation position	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 123 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Incidence of post-induction hypotension [ Time Frame: during 15 minutes after induction of anesthesia ]
   mean arterial pressure < 80% of the baseline reading

Secondary Outcome Measures :

1. 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
2. Norepinephrine consumption [ Time Frame: during 15 minutes after induction of anesthesia ]
   mcg
3. mean arterial pressure [ Time Frame: 1-minute intervals starting 1 minutes before induction of anesthesia till 15 minutes post-induction of anesthesia ]
   mmHg
4. heart rate [ Time Frame: 1-minute intervals starting 1 minutes before induction of anesthesia till 15 minutes post-induction of anesthesia ]
   beat per minutes

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Maha MA Mostafa, M.D; 01000365115 ext +2; maha.mostafa@cu.edu.eg

Locations

Egypt

Ahmed Mohamed Hasanin

Cairo, Egypt, 11432

Sponsors and Collaborators

Cairo University

More Information

Publications:

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.

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. Review.

• Responsible Party: Ahmed Hasanin, assistant professor, Cairo University
• ClinicalTrials.gov Identifier: NCT03996213
• Other Study ID Numbers: N-116-2018
• First Posted: June 24, 2019
• Last Update Posted: June 25, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypotension; Vascular Diseases; Cardiovascular Diseases