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Giving medicine dexamethasone two times as compared to one time only to decrease pain and edema after major surgery of the abdomen.

Effect of two dose versus single dose dexamethasone on pain and post-operative inflammatory response in patients undergoing major abdominal surgery: A double- blinded randomised controlled trial. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069469
Enrollment
130
Registered
2024-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Two dose dexamethasone: First dose of dexamethasone 0.2 mg/kg IV infusion in 100 ml normal saline will be given immediately following induction of anaesthesia, and second dose 0.2 mg/kg

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Priyankar Kumar Datta

All India Institute of Medical Sciences

ajishaa@gmail.com01126593212

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026