Effect of Preoperative Intravenous Fluid Infusion on Postoperative Complications
Study Details
Study Description
Brief Summary
Hypotension is associated with postoperative complications. Preoperative fluid infusion can effectively prevent post-induction hypotension of general anesthesia. Previous studies only focused on the hemodynamics after preoperative fluid infusion. Pre-operative fluid infusion can reduce the incidence of post-operative complications by preventing post-induction hypotension. The patients who is 18 years or older and undergo elective non-cardiac surgery with general anesthsia will be enrolled. The intervention is intravenous infusion of colloids or crytalloids before induction of general anesthesia. The primary outcome is the incidence of post-operative complications within 30 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Post-induction hypotension occurs in 30-40% of patients undergoing surgery under general anesthesia. Perioperative hypotension is a significant independent risk factor for post-operative myocardial injury, acute kidney injury, stroke, and significantly increases 30-day mortality rate after surgery. Perioperative hypotension has been attributed to absolute or relative hypovolaemia secondary to pre-operative fasting and to the vasodilatory and negative inotropic effects of certain induction agents. Low baseline blood volume is a risk factor for post-induction hypotension. The general consensus remains that patients entering the operating room require fluids to make up for reduced pre-operative intake. Intravenous administration of 500 mL of crystalloid solution before induction of anaesthesia did not decrease the overall incidence of cardiovascular collapse during tracheal intubation of critically ill adults compared with no fluid bolus. Among patients in the intensive care unit requiring fluid challenges, intravenous crystalloid boluses of 250 ml before intubation did not reduce 90-day mortality. Preloading colloids reduced the occurrence of post-induction hypotension and vasopressor use, improved CI, and reduced SVV during the early intraoperative period. It is unknown whether pre-operative colloids infusion can reduce the incidence of post-operative complications by preventing post-induction hypotension. We will enroll patients with 18 years or older and undergoing elective surgery under general anesthsia. The participants in colloid group will receive intravenous colloids 5ml/kg before induction of anesthesia; who in crystalloid group will receive intravenous Ringer's solution 5ml/kg before induction of anesthesia. The primary outcome in this study is the incidence of post-operative complications (Clavien-Dindo) within 30 days. The secondary outcomes include the incidence of post-induction hypotension, the doses of vasopressors and inotropes intra-operatively, lengths of stay in hospital (LOS) post-operatively, optimal recovery post-operatively within 5 days.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: colloid group The participants in colloid group will received intravenous HES130/0.4 of 5ml/kg before the Induction of anesthesia. |
Drug: Intravenous HES130/0.4 of 5ml/kg
HES130/0.4 of 5ml/kg
Other Names:
|
| Active Comparator: crystalloid group The participants in crystalloid group will received intravenous Lactated Ringer's solution of 5ml/kg before the Induction of anesthesia. |
Drug: intravenous Lactated Ringer's solution
intravenous Lactated Ringer's solution of 5ml/kg
|
Outcome Measures
Primary Outcome Measures
- The incidence of post-operative complications [within 30 days after operation]
Modified Clavien-Dindo Classification ≥ grade I
Secondary Outcome Measures
- Post-induction hypotension (PIH) [during procedure ( the time from induction of anesthesia to incision)]
MAP < 65mmHg or 20% lower than the baseline from the time of anesthsia induction to incison
- The doses of vasopressors and inotropes [intra-operatively，the time from induction of anesthesia to discharge from operating room]
including epinephrine, norepinephrine, dopamine.
- Lengths of stay in hospital (LOS) post-operatively [postoperatively within 30 days]
The time from the end of operation to discharge from hospital
- the incidence of optimal recovery [post-operatively within 5 days]
Defined as discharge within 5 days of surgery with no major complications (Clavien-Dindo ≥ III), no infections of incisions, no re-admissions to hospital, and no deaths post-operatively
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years or older
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ASA I-III
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Undergoing elective non-cardiac surgery under general aneathesia
Exclusion Criteria:
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Allergic to colloids
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Severe heart diseases ( Ejection Fraction lower than 35%)
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Presence of renal failure pre-operatively (defined as creatinine >132 μg/L and/or patient receiving renal replacement therapy)
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Body mass index greater than 35 kg/m2
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Presence of a coagulopathy at screening (defined as platelet count < 100 × 109/L and/or a prothrombin time < 70% and/or an activated partial thromboplastin time (aPTT)
35 s and/or fibrinogen <1 g/ L)
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Presence of liver injury (defined as aspartate aminotransferase and/or alanine aminotransferase >80 IU/L)
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Pre-operative electrolyte disturbances with Na >150 mmol/L and/or Cl >110 mmol/L
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xijing Hospital | Xi'an | Shaanxi | China | 710032 |
Sponsors and Collaborators
- Xijing Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY20222318