Goal-directed Therapy in High-risk Surgery

Guangzhou First People's Hospital

Status: Unknown

Conditions: Hypovolemia; Perioperative/Postoperative Complications; Hypoxia

Treatments: Procedure: Protocol group 2; Procedure: Protocol group 1

Study type: Interventional

Funder types: Other

Identifiers

NCT01681238

GZZD-025

Details and patient eligibility

About

There is growing evidence that the risk of postoperative complications can be decreased by optimizing the amount and type of infusion fluids given during surgery, steered by goal-directed therapy based on flow-related hemodynamic parameters, particularly in high-risk patients. This study is undertaken subsequently to test the hypothesis that the intraoperative goal-directed strategy based on FloTrac/Vigileo, a minimally invasive monitor, can partially prevented postoperative complications and shorten hospital stay in the elderly high-risk patients undergoing total hip replacement with continuous spinal anaesthesia .

Full description

After sedated with IV 0.02 mg/kg midazolam, all patients will receive arterial, central venous, and L3-4 intrathecal catheterizations. A T12 sensory level block was attained with ropivacaine through the intrathecal catheter. Besides currently recommended monitoring during the intraoperative period, arterial blood pressure, stroke volume (Edwards Lifesciences, Irvine, Calif.), and central venous oxygen saturation (Edwards Lifesciences) will be measured and recorded. All Patients will receive intranasal oxygen 2 mL/min and be kept normothermic (body temperature > 36°C). Patients in both groups receive 8 mL/kg/hour of Ringer's lactate solution from 30 minutes prior to induction of anaesthesia through the end of surgery, when the rate will be decreased to 100 mL/hour. In addition, boluses of colloid will be given to different protocol group according to the study arm to which the patient allocated.Postoperative care and discharge criteria were predefined using the hospital care map and protocol.

Enrollment: 72 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Adult patients scheduled for total hip replacement at this institution.
• 2. American Society of Anaesthesiologists (ASA) physical status of III or VI.
• 3. Two or more risk factors according to risk index of Lee .

Exclusion criteria

• 1. Age under 70years old
• 2. idiopathic coagulopathy: with warfarin or heparin
• 3. systemic or local infection
• 4. unable to cooperate
• 5. spinal trauma or severe low back pain history
• 6. patient refusal.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 2 patient groups

Protocol group 1

Other group

Description:

Using standard hemodynamic therapy

Treatment:

Procedure: Protocol group 1

Protocol group 2

Experimental group

Description:

Using goal-directed therapy

Treatment:

Procedure: Protocol group 2