Abdominal Neoplasms, Immunization, Perioperative Care, Surgery
Conditions
Brief summary
The purpose of this study is to find out whether perioperative fluid restriction influence on postoperative immunological function. And discuss the probable mechanism that fluid restriction regime effect on clinical data.
Detailed description
Perioperative fluid administration is a common therapy in clinical practice, and recent regime has a history about 50 years. Recently, clinicians found that traditional regime had some disadvantages, for example, pulmonary edema, increased cardiac load, increased body weight. And thus, perioperative fluid restriction regimen has been suggested and proved could reduce cardiopulmonary complications and mortality rates after major elective gastrointestinal surgery. Patients were divided into two groups randomly and underwent restricted fluid regimen or traditional fluid regimen. We determined the complications and immunological function in two groups, and analyzed the relationship between complications and immunological changes. Based on this we decide the probable mechanism that perioperative fluid restriction effects on complications.
Interventions
BEHAVIORALperioperative fluid management
No preloading of epidural analgesia,7ml/kg lactated ringer's solution was administered in first hour,and 5ml/kg.h during the following hours,and 1000ml of glucose 5% was administered on the rest of the day during operation.1000\ 1500ml crystalloid was administered on the days following operation
BEHAVIORALperioperative fluid treatment
500 mL HAES 6% was accepted as preloading of epidural analgesia,12ml/kg.h lactated ringer's solution was administered during the operation ,and 1000ml of glucose 5% was administered on the rest of the day during operation.2000\ 2500ml crystalloid was administered on the days following operation
Sponsors
Nanjing PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients(age≧65y) who was admitted for gastrointestinal cancer surgery were considered eligible if they had no life-threatening systemic disease (ASA groups 1\ 3)
Exclusion criteria
* lactation * mental disorders * language problems * smoking within two weeks * diabetes mellitus * renal insufficiency * disseminated cancer * secondary cancers * inflammatory bowel disease, or diseases hindering epidural analgesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical perioperative complications | 30 days after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| death | 30 days after surgery | — |
| adverse effects | 30 days after surgery | ischemia and impairment of renal function |
Outcome results
None listed