Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients of ASA physical status I and II scheduled for elective major open abdominal surgery
Exclusion criteria
Exclusion criteria: Diabetic COPD or asthma History of peptic ulcer disease Current or recent steroid intake within last 4 weeks Any concurrent infection BMI more than 35 Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a)mean post-operative CRP level b)mean post-operative VAS score (by asking patients to grade the worst pain experienced by them during the preceding 12 hours) Timepoint: a)postoperative days 1 and 3 and 5 b)recorded twice daily at 8-9 am and 8-9 pm up to postoperative day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| d) incidence of postoperative nausea and vomiting (PONV) and the additional use of postoperative antiemeticsTimepoint: recorded daily for the first 7 post-operative days;duration of ICU stay, duration of hospital stayTimepoint: recorded daily for the first 7 post-operative days;g) time to GI-2 recovery – defined as time to the later of upper (first tolerance of solid food) and lower (first bowel movement) gastrointestinal recovery (for patients with a stoma creation, first bowel movement was defined as more than 50–100 mL of bowel contents in the stoma bag after surgery)Timepoint: recorded daily for the first 7 post-operative days;incidence of GI bleed before hospital dischargeTimepoint: recorded daily for the first 7 post-operative days;incidence of prolonged post-operative ileus, defined as meeting 2 or more of the following criteria on or after postoperative day (POD) 4: (1) nausea or vomiting, (2) inability to tolerate an oral diet over the last 24 hours, (3) abdominal distension, and (4) radiologic confirmation.Timepoint: recorded daily for the first 7 post-operative days;incidence of surgical site infection prior to hospital dischargeTimepoint: recorded daily for the first 7 post-operative days;major postoperative complications (defined as Clavien-Dindo grade 3-4)Timepoint: recorded daily for the first 7 post-operative days;mean post-operative IL6 level Timepoint: measured on POD1, 3 & 5 ;mean SOFA scoreTimepoint: recorded daily for the first 7 post-operative days;need for rescue analgesicsTimepoint: recorded daily for the first 7 post-operative days | — |
Countries
India
Contacts
All India Institute of Medical Sciences