Goal-directed Therapy in High-risk Surgery

Not Applicable

• Conditions: Perioperative/Postoperative Complications; Hypovolemia; Hypoxia
• Interventions: Procedure: Protocol group 2; Procedure: Protocol group 1

• Registration Number: NCT01681238
• Lead Sponsor: Guangzhou First People's Hospital

Brief Summary

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 .

Detailed 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.

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-05
• Last Update Submitted: 2012-09-05
• Study First Posted: 2012-09-07
• Last Update Posted: 2012-09-07
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocol group 2	Protocol group 2	Using goal-directed therapy
Protocol group 1	Protocol group 1	Using standard hemodynamic therapy

Primary Outcome Measures

Name	Time	Method
length of postoperative hospital stay	28 days	days from end of surgery to hospital discharge.

Secondary Outcome Measures

Name	Time	Method
postoperative complications and mortality	28 days	1. Major complications: Infection , Major cardiovascular complications , Pulmonary Embolism, Renal Failure, Anaemia requiring blood transfusion in the presence of shock.; 2. Minor complications: Hypotension (systolic blood pressure \< 90 mmHg) requiring fluid boluses, Uncomplicated infections (not requiring intra-venous antibiotic therapy and with no signs of sepsis, i.e. uncomplicated urinary tract infections), Anemia requiring blood transfusions in the absence of shock.; 3. PONV: Postoperative Nausea and Vomiting; 4. delirium and postoperative cognitive dysfunction; 5. mortality

Trial Locations

Locations (1)

Guangzhou First Municipal People's Hospital; 🇨🇳 Guangzhou, Guangdong, China