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

Primary Purpose

Post-induction Hypotension

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
head down position
leg elevation position
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-induction Hypotension

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ahmed Mohamed Hasanin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

supine group

head down

leg elevation

Arm Description

induction of anesthesia will be initiated while patient in supine position

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

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

Outcomes

Primary Outcome Measures

Incidence of post-induction hypotension
mean arterial pressure < 80% of the baseline reading

Secondary Outcome Measures

Incidence of severe post-induction hypotension
defined as mean arterial pressure < 60% of the baseline reading
Norepinephrine consumption
mcg
mean arterial pressure
mmHg
heart rate
beat per minutes

Full Information

First Posted
June 21, 2019
Last Updated
June 22, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03996213
Brief Title
Comparison of the Hemodynamic Effect of Three Positions During Induction of Anesthesia
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-induction Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
supine group
Arm Type
No Intervention
Arm Description
induction of anesthesia will be initiated while patient in supine position
Arm Title
head down
Arm Type
Active Comparator
Arm Description
induction of anesthesia will be initiated while patient in head down position
Arm Title
leg elevation
Arm Type
Active Comparator
Arm Description
induction of anesthesia will be initiated while patient in leg elevation position
Intervention Type
Other
Intervention Name(s)
head down position
Intervention Description
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
Intervention Name(s)
leg elevation position
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of post-induction hypotension
Description
mean arterial pressure < 80% of the baseline reading
Time Frame
during 15 minutes after induction of anesthesia
Secondary Outcome Measure Information:
Title
Incidence of severe post-induction hypotension
Description
defined as mean arterial pressure < 60% of the baseline reading
Time Frame
during 15 minutes after induction of anesthesia
Title
Norepinephrine consumption
Description
mcg
Time Frame
during 15 minutes after induction of anesthesia
Title
mean arterial pressure
Description
mmHg
Time Frame
1-minute intervals starting 1 minutes before induction of anesthesia till 15 minutes post-induction of anesthesia
Title
heart rate
Description
beat per minutes
Time Frame
1-minute intervals starting 1 minutes before induction of anesthesia till 15 minutes post-induction of anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha MA Mostafa, M.D
Phone
01000365115
Ext
+2
Email
maha.mostafa@cu.edu.eg
Facility Information:
Facility Name
Ahmed Mohamed Hasanin
City
Cairo
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29922085
Citation
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.
Results Reference
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PubMed Identifier
23228872
Citation
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.
Results Reference
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Comparison of the Hemodynamic Effect of Three Positions During Induction of Anesthesia

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