Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ningbo No.2 Hospital | OTHER |
| The Affiliated Hospital Of Guizhou Medical University | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| colloid group | Experimental | The participants in colloid group will received intravenous Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg before the Induction of general anesthesia. |
|
| crystalloid group | Active Comparator | The participants in crystalloid group will received intravenous multiple electrolyte injection of 5ml/kg before the Induction of general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg | Drug | Intravenous Hydroxyethyl Starch 130/0.4 and Electrolyte injection of 5ml/kg before induction of general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of post-operative complications | Modified Clavien-Dindo Classification ≥ grade I | within 30 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Post-induction hypotension (PIH) | MAP < 65mmHg or 20% lower than the baseline from the time of anesthsia induction to incison | during procedure ( the time from induction of anesthesia to incision) |
| The doses of vasopressors and inotropes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Xi'an | Shaanxi | 710032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 19, 2025 | Mar 25, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
Not provided
Not provided
| The Second Affiliated Hospital of Dalian Medical University |
| OTHER |
| Yan'an University Affiliated Hospital | OTHER |
| Shenzhen University General Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
|
| Multiple Electrolytes injection of 5 ml/kg | Drug | Intravenous Multiple Electrolytes injection of 5ml/kg before induction of general anesthesia |
|
|
including epinephrine, norepinephrine, dopamine.
| intra-operatively,the time from induction of anesthesia to discharge from operating room |
| Lengths of stay in hospital (LOS) post-operatively | The time from the end of operation to discharge from hospital | postoperatively within 30 days |
| the incidence of optimal recovery | 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 | post-operatively within 5 days |
| D011134 |
| Polysaccharides |