Goal-directed Therapy in High-risk Surgery
This trial is active, not recruiting.
|Conditions||perioperative/postoperative complications, hypovolemia, hypoxia|
|Treatments||protocol group 2, protocol group 1|
|Sponsor||Guangzhou First Municipal People’s Hospital|
|Start date||September 2012|
|End date||June 2013|
|Trial size||72 participants|
|Trial identifier||NCT01681238, GZZD-025|
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 .
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
length of postoperative hospital stay
time frame: 28 days
postoperative complications and mortality
time frame: 28 days
Male or female participants at least 70 years old.
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.
|Official title||A Randomized Study of Goal-directed Therapy in the Elderly High-risk Patients Undergoing Total Hip Replacement|
|Principal investigator||Xiangcai Ruan, MD, PHD|
|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.|
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